NCT03965481

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
12mo left

Started May 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress89%
May 2018Apr 2027

Study Start

First participant enrolled

May 12, 2018

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

May 24, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 29, 2019

Completed
7.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2027

Last Updated

April 15, 2026

Status Verified

April 1, 2026

Enrollment Period

9 years

First QC Date

May 24, 2019

Last Update Submit

April 10, 2026

Conditions

Malignant Ovarian NeoplasmOvarian Carcinoma

Outcome Measures

Primary Outcomes (1)

  • Lesion detection accuracy

    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 Outcomes (3)

  • Diagnostic accuracy by location

    Up to 3 years

  • Response status

    Up to 3 years

  • Imaging and genomic data analysis

    Up to 3 years

Study Arms (1)

Diagnostic (CECT, PET-MRI)

EXPERIMENTAL

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.

Radiation: Dynamic Enhanced CTProcedure: Magnetic Resonance ImagingProcedure: Positron Emission Tomography

Interventions

Dynamic Enhanced CTRADIATION

Undergo standard CECT

Also known as: 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
Diagnostic (CECT, PET-MRI)
Magnetic Resonance ImagingPROCEDURE

Undergo PET/MRI scan

Also known as: Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging
Diagnostic (CECT, PET-MRI)
Positron Emission TomographyPROCEDURE

Undergo PET/MRI scan

Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging
Diagnostic (CECT, PET-MRI)

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Priya R Bhosale

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 24, 2019

First Posted

May 29, 2019

Study Start

May 12, 2018

Primary Completion (Estimated)

April 30, 2027

Study Completion (Estimated)

April 30, 2027

Last Updated

April 15, 2026

Record last verified: 2026-04

Locations

US(1)