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

Results pending

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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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-12

Study Completion Date

2027-04-30

Brief Summary

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This trial studies how well positron emission tomography/magnetic resonance (PET/MR) versus contrast enhanced computerized tomography (CECT) scans work in locating ovarian cancer tumors in patients with known or suspected ovarian cancer. PET, MR, and CECT scans use different methods to create images of areas inside the body. This trial is being done to see if PET/MR scans may help doctors locate ovarian cancer tumors, predict how well these tumors may be removed during surgery, and predict how patients respond to platinum-based chemotherapies compared to standard of care CECT scans.

Detailed Description

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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.

Conditions

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Malignant Ovarian Neoplasm Ovarian Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

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.

Group Type EXPERIMENTAL

Dynamic Enhanced CT

Intervention Type RADIATION

Undergo standard CECT

Magnetic Resonance Imaging

Intervention Type PROCEDURE

Undergo PET/MRI scan

Positron Emission Tomography

Intervention Type PROCEDURE

Undergo PET/MRI scan

Interventions

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Dynamic Enhanced CT

Undergo standard CECT

Intervention Type RADIATION

Magnetic Resonance Imaging

Undergo PET/MRI scan

Intervention Type PROCEDURE

Positron Emission Tomography

Undergo PET/MRI scan

Intervention Type PROCEDURE

Other Intervention Names

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Contrast-Enhanced Spiral CT Dynamic Contrast Enhanced Computed Tomography Dynamic Contrast Enhanced CT Dynamic Contrast Material Enhanced CT Dynamic Enhanced Computed Tomography Enhanced Spiral CT Magnetic Resonance Imaging Scan Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance MR MR Imaging MRI MRI Scan NMR Imaging NMRI Nuclear Magnetic Resonance Imaging Medical Imaging, Positron Emission Tomography PET PET Scan Positron Emission Tomography Scan Positron-Emission Tomography proton magnetic resonance spectroscopic imaging

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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United States

Related Links

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http://www.mdanderson.org

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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