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PET/MR Versus CECT Scans in Imaging Patients With Ovarian Cancer or Highly Suspected Ovarian Cancer

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ClinicalTrials.gov Identifier: NCT03965481
Recruitment Status : Recruiting
First Posted : May 29, 2019
Last Update Posted : May 29, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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.

Condition or disease Intervention/treatment Phase
Malignant Ovarian Neoplasm Ovarian Carcinoma Radiation: Dynamic Enhanced CT Procedure: Magnetic Resonance Imaging Procedure: Positron Emission Tomography Not Applicable

Detailed Description:

PRIMARY OBJECTIVES:

I. To compare positron emission tomography-magnetic resonance (PET/MR) and contrast enhanced computerized tomography (CECT) 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Actual Study Start Date : May 12, 2018
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : June 30, 2021


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.
Radiation: Dynamic Enhanced CT
Undergo standard CECT
Other Names:
  • 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

Procedure: Magnetic Resonance Imaging
Undergo PET/MRI scan
Other Names:
  • Magnetic Resonance Imaging Scan
  • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
  • MRI
  • MRI Scan
  • NMR Imaging
  • NMRI
  • Nuclear Magnetic Resonance Imaging

Procedure: Positron Emission Tomography
Undergo PET/MRI scan
Other Names:
  • Medical Imaging, Positron Emission Tomography
  • PET
  • PET Scan
  • Positron Emission Tomography Scan
  • Positron-Emission Tomography
  • proton magnetic resonance spectroscopic imaging




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Diagnostic accuracy by location [ Time Frame: Up to 3 years ]
    Will be analyzed using linear regression or generalized linear regression models where applicable.

  2. Response status [ Time Frame: Up to 3 years ]
    Will be analyzed using linear regression or generalized linear regression models where applicable.

  3. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03965481


Locations
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United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Priya R. Bhosale    713-792-0221    priya.bhosale@mdanderson.org   
Principal Investigator: Priya R. Bhosale         
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Priya R Bhosale M.D. Anderson Cancer Center

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT03965481     History of Changes
Other Study ID Numbers: 2017-0442
NCI-2019-02455 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2017-0442 ( Other Identifier: M D Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )
First Posted: May 29, 2019    Key Record Dates
Last Update Posted: May 29, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type