Evaluation of Response to the Neoadjuvant Chemotherapy for Advanced Ovarian Cancer by Multimodal Functional Imaging (IMOVA)

Evaluation of Response to the Neoadjuvant Chemotherapy for Advanced Ovarian Cancer by Multimodal Functional Imaging (Fusion MRI and FDG-PET-CT)

This study evaluates the therapeutic response by modern FMRI and PET techniques with the perspective to exploit multimodal data (fusion MRI/PET). The Sponsor would like to optimize the respective performances and to define the early assessment criteria, at the first detox, of the treatment efficacy, with and without antiangiogenic agent.

Study Overview

• Status: Completed
• Conditions: Ovarian Cancer
• Intervention / Treatment: Device: Functional Imaging previous the second course; Device: Functional Imaging previous the surgery

Detailed Description

This study evaluates the therapeutic response by modern FMRI and PET techniques with the perspective to exploit multimodal data (fusion MRI/PET). The Sponsor would like to optimize the respective performances and to define the early assessment criteria, at the first detox, of the treatment efficacy, with and without antiangiogenic agent. It is a single center evaluation of the study treatment.

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Gironde
    • Bordeaux, Gironde, France, 33076
      • Institut Bergonie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Epithelial ovarian carcinoma, fallopian tube, or primary peritoneal carcinoma FIGO IIIC-IV histologically confirmed by biopsy and documented stage and untreated
• Pre-treatment abdominopelvic PET-CT and MRI within 4 weeks before neoadjuvant chemotherapy.
• During laparoscopy performed by an experienced surgeon in the treatment of ovarian cancer, patient considered ineligible for tumor cell kill at the outset.
• A life expectancy of greater than three months
• An eligible patient for Paclitaxel and Carboplatine based chemotherapy.
• Membership of a social security scheme
• Patient information and signed, dated written informed consent

Exclusion Criteria:

• Pre-treated using chemotherapy, radiology, or surgery for an ovarian cancer.
• Contraindication to MRI with the injection of contrast product, i.e, the first three months pregnancy, claustrophobia, major allergic antecedents, pacemaker, some surgery clips, some heart valves, cava filter, implanter pumps, cochlear implants, metallic extraneous malter.
• Uncontrolled diabetes
• Pregnancy and nursing
• Other uncontrolled medical conditions as thyroid pathology, neuropsychiatric disease, infection, coronary insufficiency or grade 3 - 4 heart disease established by association "New York Heart"
• Patient deprived of liberty and legally protect adult, or not in position to give consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Functional imaging; A pilot study to evaluate the response to neoadjuvant chemotherapy for advanced ovarian cancer by multimodal functional imaging (Fusion MRI and FDG-PET-CT)

Device: Functional Imaging previous the second course; Functional Imaging before and after 1 cycle of chemotherapy treatment, in the previous 4 days before the second course: PET1 and MRI1; Device: Functional Imaging previous the surgery; Functional Imaging after 4 cycles of chemotherapy treatment, in the 3 weeks after the chemotherapy, before the interval surgery: PET4 and MRI4 The RECIST evaluation will be done, usually, by scanner to 4 courses of chemotherapy before the surgery interval

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inter-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Individual Intra-class Correlation Coefficients by Location	Individual intra-class correlation coefficients by location (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter SUVmax of functional imaging positron emission tomography. The functional imaging positron emission tomography will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.	Pre-therapeutic
Inter-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Average Intra-class Correlation Coefficients by Location	Average intra-class correlation coefficients(Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter SUVmax of functional imaging positron emission tomography. The functional imaging positron emission tomography will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.	Pre-therapeutic
Inter-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Individual Intra-class Correlation Coefficients by Location	Individual intra-class correlation coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter MTV of functional imaging Positron Emission Tomography. The functional imaging positron emission tomography will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.	Pre-therapeutic
Inter-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Average Intra-class Correlation Coefficients by Location	Average intra-class correlation coefficients (Absolute agreement) arepresented by location to evaluate the reliability between observers of quantization parameter MTV of functional imaging Positron Emission Tomography. The functional imaging Positron Emission Tomography will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.	Pre-therapeutic
Inter-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Individual Intra-class Correlation Coefficients by Location	Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter ADC of functional imaging Magnetic Resonance Imaging. The Magnetic Resonance Imaging will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.	Pretherapeutic
Inter-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Average Intra-class Correlation Coefficients by Location	Average intra-class correlation coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter ADC of functional imaging Magnetic Resonance Imaging. The Magnetic Resonance Imaging will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.	Pretherapeutic
Inter-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Individual Intra-class Correlation Coefficients by Location	Individual Intra-class Correlation (Absolute agreement) are presented by location to evaluate the reliability within observers of quantization parameter SUVmax of functional imaging Positron Emission Tomography (PET). The functional imaging Positron Emission Tomography (PET) will be interpreted twice by radiologist and nuclear medicine specialist.	After one cycle of chemotherapy, 3 weeks
Inter-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Average Intra-class Correlation Coefficients by Location	Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter SUVmax of functional imaging Positron Emission Tomography (PET) . The functional imaging Positron Emission Tomography (PET) will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.	After one cycle of chemotherapy, 3 weeks
Inter-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Individual Intra-class Correlation Coefficients by Location	Individual intra-class correlation coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter MTV of functional imaging Positron Emission Tomography (PET). The functional imaging Positron Emission Tomography (PET) will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.	After one cycle of chemoterapy, 3 weeks
Inter-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Average Intra-class Correlation Coefficients by Location	Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter MTV of functional imaging Positron Emission Tomography (PET). The functional imaging Positron Emission Tomography (PET) will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.	After one cycle of chemotherapy, 3 weeks
Inter-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Individual Intra-class Correlation Coefficients by Location	Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter ADC of Magnetic Resonance Imaging (MRI). The Magnetic Resonance Imaging will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.	After one cycle of chemotherapy, 3 weeks
Inter-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Average Intra-class Correlation Coefficients by Location	Average intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter ADC of Magnetic Resonance Imaging (MRI). The Magnetic Resonance Imaging will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.	After one cycle of chemotherapy, 3 weeks
Inter-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Individual Intra-class Correlation Coefficients by Location	Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter SUVmax of functional imaging positron emission tomography (PET) . The functional imaging positron emission tomography will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.	After four cycles of chemotherapy, 12 weeks
Inter-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Average Intra-class Correlation Coefficients by Location	Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter SUVmax of functional imaging positron emission tomography (PET). The functional imaging positron emission tomography will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.	After four cycles of chemotherapy, 12 weeks
Inter-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Individual Intra-class Correlation Coefficients by Location	Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter MTV of functional imaging Positron Emission Tomography (MTV). The functional imaging Positron Emission Tomography will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.	After four cycles of chemoterapy, 12 weeks
Inter-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - AverageIntra-class Correlation Coefficients by Location	Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter MTV of functional imaging Positron Emission Tomography (PET). The functional imaging Positron Emission Tomography will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.	After four cycles of chemotherapy, 12 weeks
Inter-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Individual Intra-class Correlation Coefficients by Location	Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter ADC of functional imaging Magnetic Resonance Imaging (MRI). The Magnetic Resonance Imaging will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.	After four cycles of chemotherapy, 12 weeks
Inter-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Average Intra-class Correlation Coefficients by Location	Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter of ADC functional imaging Magnetic Resonance Imaging (MRI). The Magnetic Resonance Imaging will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.	After four cycles of chemotherapy, 12 weeks
Intra-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Individual Intra-class Correlation Coefficients by Location	Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameter ADC of functional imaging positron emission tomography (PET). The functional imaging positron emission tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist.	Pre-therapeutic
Intra-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Average Intra-class Correlation Coefficients by Location	Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameter SUVmax of functional imaging positron emission tomography (PET) . The imaging positron emission tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist.	Pre-therapeutic
Intra-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Individual Intra-class Correlation Coefficients by Location	Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameters functional imaging Positron Emission Tomography (MTV). The functional imaging Positron Emission Tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist.	Pre-therapeutic
Intra-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Average Intra-class Correlation Coefficients by Location	Average Intra-class Correlation Coefficients by Location (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameters MTV of functional imaging Positron Emission Tomography. The functional imaging Positron Emission Tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist.	Pre-therapeutic
Intra-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Individual Intra-class Correlation Coefficients by Location	Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observers of quantization parameter ADC of Magnetic Resonance Imaging (MRI). The Magnetic Resonance Imaging will be interpreted independently twice by the same radiologist and nuclear medicine specialist.	Pretherapeutic
Intra-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Average Intra-class Correlation Coefficients by Location	Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observers of quantization parameter ADC of Magnetic Resonance Imaging (MRI) . The Magnetic Resonance Imaging will be interpreted independently twice by the same radiologist and nuclear medicine specialist.	Pretherapeutic
Intra-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Individual Intra-class Correlation Coefficients by Location	Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameter SUV max of functional imaging positron emission tomography (PET). The functional imaging positron emission tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist.	After one cycle of chemoterapy, 3 weeks
Intra-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Average Intra-class Correlation Coefficients by Location	Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameter SUVmax of functional imaging positron emission tomography (PET). The functional imaging positron emission tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist.	After once cycle of chemoterapy, 3 weeks
Intra-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Individual Intra-class Correlation Coefficients by Location	Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameter MTV of functional imaging Positron Emission Tomography (PET). The functional imaging Positron Emission Tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist.	After one cycle of chemoterapy, 3 weeks
Intra-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Average Intra-class Correlation Coefficients by Location	Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameter MTV of functional imaging Positron Emission Tomography (PET). The functional imaging Positron Emission Tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist.	After once cycle of chemotherapy, 3 weeks
Intra-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Individual Intra-class Correlation Coefficients by Location	Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observers of quantization parameter ADC of Magnetic Resonance Imaging (MRI). The Magnetic Resonance Imaging will be interpreted independently twice by the same radiologist and nuclear medicine specialist.	After one cycle of chemotherapy, 3 weeks
Intra-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Average Intra-class Correlation Coefficients by Location	Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observers of quantization parameter ADC of Magnetic Resonance Imaging (MRI). The Magnetic Resonance Imaging will be interpreted independently twice by the same radiologist and nuclear medicine specialist.	After one cycle of chemotherapy, 3 weeks
Individual Intra-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Individual Intra-class Correlation Coefficients by Location	Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameter SUVmax of functional imaging positron emission tomography (PET). The functional imaging positron emission tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist.	After four cycles of chemoterapy, 12 weeks
Intra-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Average Intra-class Correlation Coefficients by Location	Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameter SUVmax of functional imaging positron emission tomography (PET). The functional imaging positron emission tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist.	After four cycles of chemoterapy, 12 weeks
Intra-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Individual Intra-class Correlation Coefficients by Location	Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameter MTV functional imaging positron emission tomography (PET). The functional imaging positron emission tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist.	After four cycle of chemoterapy, 12 weeks
Intra-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Average Intra-class Correlation Coefficients by Location	Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameter MTV functional imaging positron emission tomography (PET). The functional imaging positron emission tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist.	After four cycles of chemotherapy, 12 weeks
Intra-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Individual Intra-class Correlation Coefficients by Location	Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observers of quantization parameter ADC of functional imaging Magnetic Resonance Imaging (MRI). The Magnetic Resonance Imaging will be interpreted independently twice by the same radiologist and nuclear medicine specialist.	After four cycles of chemotherapy, 12 weeks
Intra-rater Reliability of PET Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Average Intra-class Correlation Coefficients by Location	Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observers of quantization parameter ADC of Magnetic Resonance Imaging (MRI). The Magnetic Resonance Imaging will be interpreted independently twice by the same radiologist and nuclear medicine specialist.	After four cycles of chemotherapy, 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival		10 months
Spearman Correlation Coefficient Between Marker CA125 and the Relative Variations (Between Pretherapeutic and After One Cycle of Chemotherapy) of the PET Parameters (SUVmax, MTV, SUVN, SUL and TLG)	In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy). In other words, without paying attention to assessment times and the location of the lesion, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyse. The appearance of new lesions (not present at baseline) has not been taken into account in the calculation of relative variations. The disappearance of pre-existing lesions at baseline has been taken into account in the calculation of relative variations. Relative variations has been calculated as the difference between the values collected after 1 cycle of chemotherapy and the pre-therapeutic value divided by the pre-therapeutic value.	After one cycle of chemotherapy, 3 weeks
Spearman Correlation Coefficient Between Marker CA125 and the Relative Variations (Between Pre-therapeutic and After Four Cycles of Chemotherapy) of the PET Parameters (SUVmax, MTV, SUVN, SUL and TLG)	In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy). In other words, without paying attention to assessment times and the location of the lesion, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyse. The appearance of new lesions (not present at baseline) has not been taken into account in the calculation of relative variations. The disappearance of pre-existing lesions at baseline has been taken into account in the calculation of relative variations. Relative variations has been calculated as the difference between the values collected after 4 cycles of chemotherapy and the pre-therapeutic value divided by the pre-therapeutic value.	After four cycles of chemotherapy, 12 weeks
Spearman Correlation Test Between the Relative Variation of Apparent Diffusion Coefficient (ADC) and Marker CA125	In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses. The appearance of new lesions (not present at baseline) has not been taken into account in the calculation of relative variations. The disappearance of pre-existing lesions at baseline has been taken into account in the calculation of relative variations. Relative variations has been calculated as the difference between the values collected after 1 or 4 cycles of chemotherapy and the pre-therapeutic value divided by the pre-therapeutic value.	After one and four cycle(s) of chemotherapy (after 3 and 12 weeks)
Complete Surgery Resection		Interval surgery visit: up to 3 weeks after cycle 4 of chemotherapy and until the day before the surgery
Descriptive Statistics of Relative Variations of PET Parameter SUVmax by Response as Per RECIST V1.1	In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses. Relative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0).	After one cycle of chemotherapy, 3 weeks
Descriptive Statistics of Relative Variations of PET Parameter SUVmax by Response as Per RECIST V1.1	In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses. RRelative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0).	After four cycles of chemotherapy, 12 weeks
Descriptive Statistics of Relative Variations of PET Parameter MTV by Response as Per RECIST V1.1	In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses. Relative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0).	After four cycles of chemotherapy, 12 weeks
Descriptive Statistics of Relative Variations of PET Parameter MTV by Response as Per RECIST V1.1	In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses. Relative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0).	After one cycle of chemotherapy, 3 weeks
Descriptive Statistics of Relative Variations of PET Parameter SUVN by Response as Per RECIST V1.1	In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses. Relative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0).	After one cycle of chemotherapy, 3 weeks
Descriptive Statistics of Relative Variations of PET Parameter SUVN by Response as Per RECIST V1.1	In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses. Relative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0).	After four cycles of chemotherapy, 12 weeks
Descriptive Statistics of Relative Variations of PET Parameter TLG by Response as Per RECIST V1.1	In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses. Relative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0).	After one cycle of chemotherapy, 3 weeks
Descriptive Statistics of Relative Variations of PET Parameter TLG by Response as Per RECIST V1.1	In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses. Relative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0).	After four cycles of chemotherapy, 12 weeks
Descriptive Statistics of Relative Variations of PET Parameter SUL by Response as Per RECIST V1.1	In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses. Relative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0).	After one cycle of chemotherapy, 3 weeks
Descriptive Statistics of Relative Variations of PET Parameter SUL by Response as Per RECIST V1.1	In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses. Relative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0).	After four cycles of chemotherapy, 12 weeks
Descriptive Statistics of Relative Variations of MRI Parameter ADC by Response as Per RECIST V1.1	In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses. Relative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0).	After one cycle of chemotherapy, 3 weeks
Descriptive Statistics of Relative Variations of MRI Parameters ADC by Response as Per RECIST V1.1	In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses. Relative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0).	After four cycles of chemotherapy, 12 weeks
Peritoneal Extent Assessed by Fagotti Score Using MRI Data	The Fagotti score ranges from 0 to 14 and is used to evaluate the peritoneal damage of patients. This score was collected during pretherapy and after 4 cycles of chemotherapy. The higher the stage number is, the further the cancer has spread. The Fagotti questionnaire has 7 items. A subscale value of 0 or 2 is assigned depending on whether the disease is present in those specific sites : large omentum, peritoneal carcinosis , diaphragmatic carcinosis, mesenteric retraction, intestinal infiltration, stomach infiltration,liver metastases. The sum of subscale values corresponds to Fagotti score.	Pre-therapeutic
Peritoneal Extent Assessed by Fagotti Score Using MRI Data	TThe Fagotti score ranges from 0 to 14 and is used to evaluate the peritoneal damage of patients. This score was collected during pretherapy and after 4 cycles of chemotherapy. The higher the stage number is, the further the cancer has spread. The Fagotti questionnaire has 7 items. A subscale value of 0 or 2 is assigned depending on whether the disease is present in those specific sites : large omentum, peritoneal carcinosis , diaphragmatic carcinosis, mesenteric retraction, intestinal infiltration, stomach infiltration,liver metastases. The sum of subscales corresponds to Fagotti score.	Interval surgery visit: up to 3 weeks after cycle 4 of chemotherapy and until the day before the surgery
Progression-free Survival as Per RECIST v1.1		9, 13, 14 months

Collaborators and Investigators

• Sponsor: Institut Bergonié
• Collaborators: Roche Pharma AG; Ligue contre le cancer, France
• Investigators: Study Chair: Anne-Laure CAZEAU, MD, Institut Bergonie

Publications and helpful links

Helpful Links

• Site internet du promoteur, l'Institut Bergonié
• Registre des essais cliniques de l'Institut National du Cancer

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Actual): January 1, 2017
• Study Completion (Actual): August 1, 2017

Study Registration Dates

• First Submitted: April 26, 2016
• First Submitted That Met QC Criteria: June 2, 2016
• First Posted (Estimate): June 8, 2016

Study Record Updates

• Last Update Posted (Actual): April 21, 2021
• Last Update Submitted That Met QC Criteria: March 25, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Genital Neoplasms, Female; Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Endocrine Gland Neoplasms; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
• Other Study ID Numbers: IB 2013-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO