- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03965481
PET/MR Versus CECT Scans in Imaging Patients With Ovarian Cancer or Highly Suspected Ovarian Cancer
Comparing Accuracy of PET/MR vs. CECT in Assessment of Peritoneal Disease for Resectability in Patients With Ovarian Cancer or Highly Suspected Ovarian Cancer
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVE:
I. To compare PET/MR and contrast enhanced computed tomography (CT) to determine the accuracy in patients with advanced-stage serous ovarian cancer or highly suspected ovarian cancer using diagnostic laparoscopy as the gold standard with respect to lesion detection.
SECONDARY OBJECTIVES (EXPLORATORY):
I. Correlating imaging findings such as enhancement pattern, apparent diffusion coefficient (ADC) values, standardized uptake value (SUV) values, and advanced image analytics such as texture with pathology and genomic analysis for those lesions evaluated as a discovery arm.
II. Assess whether MR (multiparametric and functional) and PET findings predict response to platinum based chemotherapy.
III. To compare PET/MR and contrast enhanced CT to predict tumor negative (R0) resection using surgery as the gold standard.
OUTLINE:
Patients undergo standard of care CECT scan and PET-MRI scan over 90-120 minutes within 30 days before laparoscopy or cytoreduction. Patients who do not undergo cytoreduction based on diagnostic laparoscopy undergo additional PET-MRI and standard of care CECT scans after completion of chemotherapy and before cytoreduction.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Texas
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Houston, Texas, United States, 77030
- M D Anderson Cancer Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients with ovarian cancer or highly suspected ovarian cancer who are eligible to undergo laparoscopic evaluation for resectability will be enrolled in the trial.
- Patients who have estimated glomerular filtration rate (eGFR) > 30.
Exclusion Criteria:
- Patients allergic to gadolinium.
- Patients who have eGRF < 30.
- Patients with cardiac pacers.
- Pediatric patients.
- Greater than 400 pounds in weight.
- Blood glucose (> 200 mg/dl).
- Pregnant women.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Diagnostic (CECT, PET-MRI)
Patients undergo standard of care CECT scan and PET-MRI scan over 90-120 minutes within 30 days before laparoscopy or cytoreduction.
Patients who do not undergo cytoreduction based on diagnostic laparoscopy undergo additional PET-MRI and standard of care CECT scans after completion of chemotherapy and before cytoreduction.
|
Undergo standard CECT
Other Names:
Undergo PET/MRI scan
Other Names:
Undergo PET/MRI scan
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Lesion detection accuracy
Time Frame: Up to 3 years
|
Lesion detection accuracy will be summarized using frequencies and percentages by modality.
McNemar's test will be used to compare accuracies between positron emission tomography (PET)/magnetic resonance (MR) and contrast enhanced computerized tomography (CECT).
Other diagnostic metrics (sensitivity, specificity, positive predictive value, and negative predictive value) will be estimated along with 95% confidence intervals.
Logistic regression model will be used to assess effect of patient and tumor characteristics on diagnostic accuracy.
|
Up to 3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Diagnostic accuracy by location
Time Frame: Up to 3 years
|
Will be analyzed using linear regression or generalized linear regression models where applicable.
|
Up to 3 years
|
Response status
Time Frame: Up to 3 years
|
Will be analyzed using linear regression or generalized linear regression models where applicable.
|
Up to 3 years
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Imaging and genomic data analysis
Time Frame: Up to 3 years
|
Correlation between imaging and genomic data will be analyzed using linear regression or generalized linear regression models where applicable.
|
Up to 3 years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Priya R Bhosale, M.D. Anderson Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Genital Diseases
- Genital Diseases, Female
- Ovarian Neoplasms
- Carcinoma, Ovarian Epithelial
Other Study ID Numbers
- 2017-0442 (Other Identifier: M D Anderson Cancer Center)
- NCI-2019-02455 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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