Malignant Ovarian NeoplasmNCT03965481
PET/MR Versus CECT Scans in Imaging Patients With Ovarian Cancer or Highly Suspected Ovarian Cancer
A study testing Dynamic Enhanced CT, Magnetic Resonance Imaging and Positron Emission Tomography in people with Malignant Ovarian Neoplasm and Ovarian Carcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Malignant Ovarian Neoplasm, Ovarian Carcinoma
- What is being tested?
- Dynamic Enhanced CT, Magnetic Resonance Imaging and Positron Emission Tomography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 12 May 2018to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing Accuracy of PET/MR vs. CECT in Assessment of Peritoneal Disease for Resectability in Patients With Ovarian Cancer or Highly Suspected Ovarian Cancer
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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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):
- 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
- Malignant Ovarian Neoplasm, Ovarian Carcinoma
- Being tested
- Dynamic Enhanced CT, Magnetic Resonance Imaging, Positron Emission Tomography
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic Enhanced CTRadiation
Also called Contrast-Enhanced Spiral CT, Dynamic Contrast Enhanced Computed Tomography, Dynamic Contrast Enhanced CT, Dynamic Contrast Material Enhanced CT
Undergo standard CECT
Magnetic Resonance ImagingProcedure or surgery
Also called Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging
Undergo PET/MRI scan
Positron Emission TomographyProcedure or surgery
Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan
Undergo PET/MRI scan
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Radiation: Dynamic Enhanced CT; Procedure: Magnetic Resonance Imaging; Procedure: Positron Emission Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 3 years
Secondary outcomes (3)
Diagnostic accuracy by location
Will be analyzed using linear regression or generalized linear regression models where applicable.
Measured: Up to 3 years
Response status
Will be analyzed using linear regression or generalized linear regression models where applicable.
Measured: Up to 3 years
Imaging and genomic data analysis
Correlation between imaging and genomic data will be analyzed using linear regression or generalized linear regression models where applicable.
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2019
- Study start12 May 2018
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Ovarian NeoplasmStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Priya R Bhosale, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03965481
- Sponsor's protocol ID
- 2017-0442
- Other IDs
- NCI-2019-02455, 2017-0442
- Status last verified
- Oct 2026
- First submitted
- 24 May 2019
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Accuracy of PET/MR vs. CECT in Assessment of Peritoneal Disease for Resectability in Patients With Ovarian Cancer or Highly Suspected Ovarian Cancer
- ClinicalTrials.gov ID
- NCT03965481
- Acronym / sponsor ID
- 2017-0442
- Conditions
- Malignant Ovarian Neoplasm, Ovarian Carcinoma
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 21 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 12 May 2018 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 29 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
PRIMARY OBJECTIVE:
- 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):
- 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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (CECT, PET-MRI) | Experimental | Radiation: Dynamic Enhanced CT, Procedure: Magnetic Resonance Imaging, Procedure: Positron Emission TomographyPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (7 listed)
- Patients allergic to gadolinium.
- Patients who have eGRF < 30.
- Patients with cardiac pacers.
- Pediatric patients.
- Greater than 400 pounds in weight.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dynamic Enhanced CTAlso: Contrast-Enhanced Spiral CT, Dynamic Contrast Enhanced Computed Tomography, Dynamic Contrast Enhanced CT, Dynamic Contrast Material Enhanced CTUndergo standard CECT | Radiation | Diagnostic (CECT, PET-MRI) |
| Magnetic Resonance ImagingAlso: Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR ImagingUndergo PET/MRI scan | Procedure or surgery | Diagnostic (CECT, PET-MRI) |
| Positron Emission TomographyAlso: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography ScanUndergo PET/MRI scan | Procedure or surgery | Diagnostic (CECT, PET-MRI) |
Primary outcome
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.
3 secondary outcomes
Diagnostic accuracy by location
Time frame: Up to 3 years
Response status
Time frame: Up to 3 years
Imaging and genomic data analysis
Time frame: Up to 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Priya R Bhosale principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dynamic Enhanced CT, Magnetic Resonance Imaging and Positron Emission Tomography in people with Malignant Ovarian Neoplasm and Ovarian Carcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lesion detection accuracy (time frame: Up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.