PET/MR Versus CECT Scans in Imaging Patients With Ovarian Cancer or Highly Suspected Ovarian Cancer
NCT ID: NCT03965481
Last Updated: 2025-10-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
21 participants
INTERVENTIONAL
2018-05-12
2027-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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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.
Dynamic Enhanced CT
Undergo standard CECT
Magnetic Resonance Imaging
Undergo PET/MRI scan
Positron Emission Tomography
Undergo PET/MRI scan
Interventions
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Dynamic Enhanced CT
Undergo standard CECT
Magnetic Resonance Imaging
Undergo PET/MRI scan
Positron Emission Tomography
Undergo PET/MRI scan
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients who have estimated glomerular filtration rate (eGFR) \> 30.
Exclusion Criteria
* Patients who have eGRF \< 30.
* Patients with cardiac pacers.
* Pediatric patients.
* Greater than 400 pounds in weight.
* Blood glucose (\> 200 mg/dl).
* Pregnant women.
18 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Priya R Bhosale
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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M D Anderson Cancer Center
Houston, Texas, United States
Countries
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Related Links
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MD Anderson Cancer Center Website
Other Identifiers
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NCI-2019-02455
Identifier Type: REGISTRY
Identifier Source: secondary_id
2017-0442
Identifier Type: OTHER
Identifier Source: secondary_id
2017-0442
Identifier Type: -
Identifier Source: org_study_id
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