Imaging Study in Advanced Ovarian Cancer (ISAAC)

A Comparison Between Ultrasound, CT (CT) and Whole-body Diffusion-weighted MRI (WB-DWI/MRI) in the Assessment of Operability in Patients With Ovarian Cancer

The aim of the study is the assessment of tumour sites critical for the achievement of optimal cytoreduction in patients with advanced ovarian cancer using Ultrasound, CT and WB-DWI/MRI. The study uses an equivalence design with a hypothesis that cases with non-resectable disease identified by Index test (Ultrasound, CT and WB-DWI MRI) are equivalent to a portion of cases identified during surgery.

Study Overview

• Status: Unknown
• Conditions: Ovarian Cancer
• Intervention / Treatment: Diagnostic test: Ultrasound, CT and WB-DWI/MRI

Detailed Description

Patients with abdominal or pelvic mass suspicious of primary ovarian, tubal or peritoneal cancer using subjective assessment by experienced sonographer (principal investigator) will be enrolled in the study and send to surgical planning. During surgical planning, the CT and MRI will be scheduled and the patient ́s consent will be requested if inclusion criteria are fulfilled. Please note, tumors with atypical morphology and/or tumor spread suspicious for secondary ovarian cancer will be first subjected to a tru-cut biopsy and will be included if histopathology confirms adnexal or peritoneal cancer.

Ultrasound will be always performed by the principal investigator in each center. Principal investigator is an ultrasound expert with level II or III EFSUMB accreditation (http://www.efsumb.org/). Operators performing ultrasound scan and radiologists performing CT or MRI will be well instructed and educated about standardized approach and criteria of inoperability. Sonographers and radiologists will be blinded to the results of other imaging modalities. If a patient already had CT or WB-DWI/MRI done by the referring hospital, the study radiologists will decide about the quality of imaging and necessity to repeat CT or WB-DWI/MRI.

The decision to treat by PDS (primary debulking surgery), or by NACT (neoadjuvant chemotherapy) with IDS (interval debulking surgery) will be based on departmental guidelines taking into account medical comorbidities and disease-related factors. If a patient is indicated for NACT a tru-cut biopsy or/and a diagnostic laparoscopy are performed. The clinicians will document why the primary debulking surgery was not considered. The surgery (laparoscopy, primary or interval debulking surgery) should always be performed within four weeks after the index test. Patients without surgical exploration will be excluded.

Surgeons performing laparoscopy will describe site to site involvement and in case of inoperability will take a biopsy and document reasons for abandoning laparotomy. In operable cases surgeons performing laparotomy will describe site to site involvement and where applicable reasons for not achieving optimal cytoreduction defined as no residual tumor left in situ at the end of surgery (R0).

If the patient has only ultrasound and CT (and not WB-DWI/MRI) she can still be included in the study. Similarly if the patient undergoes interval debulking surgery she can be included in the study if the index tests will be performed less than 4 week before IDS.

Clinical data and four evaluation forms will be filled in (Ultrasound, CT, MRI, Surgery) immediately after the procedure using electronic database. The evaluation form from histopathology will be filled when available by principal investigator. The database cannot be saved unless all the information required are filled in and it will not be available to any other investigator. Data will be submitted for statistical analysis.

• Study Type: Observational
• Enrollment (Anticipated): 400

Contacts and Locations

Study Locations

• Czechia
  • Prague, Czechia, 15000
    • Gynecologic Oncology Center in Prague

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Patients with an abdominal or pelvic mass suspicious of primary ovarian, tubal or peritoneal cancer

Description

Inclusion Criteria:

1. Abdominal or pelvic mass suspicious of primary ovarian, tubal or peritoneal cancer using subjective assessment by experienced sonographer.
2. Surgery (PDS or IDS) within 4 weeks from the index test.
3. 18 > Age < 80.
4. ECOG (Eastern Cooperative Oncology Group) grade < 3.
5. Patients after NACT can be included.

Exclusion Criteria:

1. Lesions suspected as being borderline ovarian tumors (BOT) on ultrasound.
2. Patients with supradiaphragmatic metastases
3. Contraindications to CT
4. Medical contraindications to surgery
5. Refusal or withdrawal of written informed consent
6. Time lapse between ultrasound and surgery more than 4 weeks
7. Current pregnancy

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Ovarian cancer patients; Patients with abdominal or pelvic mass suspicious of primary ovarian, tubal or peritoneal cancer submitted to the index test (Ultrasound, CT and WB/DWI-MRI) with perspective of primary surgery	Diagnostic test: Ultrasound, CT and WB-DWI/MRI; Preoperative assessment with Ultrasound, CT and WB-DWI/MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Preoperative identification of patients with ovarian/tubal cancer in whom optimal debulking (R0/R1) can not be achieved by US and CT scan.	Optimal debulking is defined as residual disease <1cm	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of the diagnostic performance in the detection of involvement of individual sites relevant for clinical management and in the detection of 24 individual sites described in the evaluation form.	Detection of involvement of individual sites relevant for clinical management:RectosigmoidColon (except ileocecum)IleocaecumLesser omentumSmall intestineLiverDiaphragmPleura; Detection of 24 individual sites described in the evaluation form (17 peritoneal sites and 7 lymph nodes sites). The aim is to clarify the diagnostic performance of the different imaging methods in the assessment of tumor extent in form of peritoneal carcinomatosis and metastatic lymph nodes. The investigators want to establish the overall accuracy of each imaging modality in all the metastatic sites. The major interest lies in the sites that determine the extent of surgery and optimal cytoreduction, in particular bowel resection, lesser omentum, superficial liver metastases, diaphragm or pleura.	24 months
Prediction model of achievement of optimal cytoreduction.	Prediction of optimal cytoreduction based on preoperative imaging. Optimal cytoreduction is defined as no residual tumor left at the end of surgery (R0).	24 months
Markers influencing accuracy - FIGO stage	Assessment of markers influencing diagnostic accuracy of individual methods: FIGO stage - it will be analised if the accuracy of the imaging methods change between early stages (I-II) and late stages (III-IV) of the disease	24 months
Markers influencing accuracy - Histological type	Assessment of markers influencing diagnostic accuracy of individual methods: Histological type - it will be analised if the accuracy of the imaging methods change between serous type and other histological types	24 months
Markers influencing accuracy - Origin	Assessment of markers influencing diagnostic accuracy of individual methods: Origin - it will be analised if the accuracy of the imaging methods change between ovarian origin and tubal origin	24 months
Markers influencing accuracy - Intraperitoneal fluid	Assessment of markers influencing diagnostic accuracy of individual methods: Intraperitoenal fluid - it will be analised if the accuracy of the imaging methods change between < or = 400 mL and > 400 mL	24 months
Markers influencing accuracy - Age	Assessment of markers influencing diagnostic accuracy of individual methods: Age - it will be analised if the accuracy of the imaging methods change between women with < or = 65 and > 65 years old	24 months
Markers influencing accuracy - CA 125	Assessment of markers influencing diagnostic accuracy of individual methods: CA 125 - it will be analised if the accuracy of the imaging methods change between < or = 300 U/mL and > 300 U/mL	24 months
Markers influencing accuracy - Postmenopausal status	Assessment of markers influencing diagnostic accuracy of individual methods: Postmenopausal status - it will be analised if the accuracy of the imaging methods change between premnopausal and postmenopausal status	24 months
Markers influencing accuracy - Body mass index	Assessment of markers influencing diagnostic accuracy of individual methods: Body mass índex - it will be analised if the accuracy of the imaging methods change between < or = 25 kg/m2 and > 25 kg/m2	24 months
Markers influencing accuracy - Image quality	Assessment of markers influencing diagnostic accuracy of individual methods: Image quality - it will be analised if the accuracy of the imaging methods change between good, moderate and poor image quality	24 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Method Friendly Questionnaire	Evaluation of patients' experience of the imaging modalities using Patient Method Friendly Questionnaire. The aim of the questionnaire is to evaluate the overall experience through the different imaging methods and to evaluate relevant factors that may had a negative impact on the examination. The answers should be in a 4-point scale (1-very disappointing; 2-disappointing; 3- satisfied; 4-very satisfied) except the level of pain that should be in a 10-scale of pain (1 - no pain; 10 - maximum pain)	24 months
Excluded patients	Monitorization of excluded patients using an evaluation form filled by the principal investigator or study coordinator in each center. It has to be chosen one of the next options: Age <18 or > 80 years old; Poor performance status ECOG >3; Histologic report of biopsy of a non-gynecologic cancer; Contraindications to upfront LPS or LPT (only tru-cut biopsy +/- NACT); Contraindications to CT; Consent not given by the patient (denial or withdrawal of oral informed consent); Absence of insurance; Time between ultrasound and surgery more than 4 weeks; Current pregnancy; Death; Others, please specify:	24 months
Record of choice of treatment	Record of multidisciplinary team choice of primary surgery or neoadjuvant chemotherapy to clarify personal and external factors in decision making	24 months

Collaborators and Investigators

• Sponsor: Charles University, Czech Republic
• Investigators: Study Chair: Daniela Fischerová, MD, PhD, Gynecologic Oncology Center, Department of Obstetrics and Gynecology, General University Hospital in Prague and 1st Medical Faculty of the Charles University, Prague, Czech Republic

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2020
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: October 28, 2018
• First Submitted That Met QC Criteria: January 15, 2019
• First Posted (Actual): January 18, 2019

Study Record Updates

• Last Update Posted (Actual): January 18, 2019
• Last Update Submitted That Met QC Criteria: January 15, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Ultrasound; Imaging; Ovarian cancer; CT; WB-DW/MRI
• 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: č.j. 29/18

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No