Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Digestive System Diseases

Rare Diseases

Carcinoma

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Peritoneal Diseases

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Ovarian Cancer

Ovarian Epithelial Cancer

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

Magnetic Resonance Imaging

Positron Emission Tomography

Priya R Bhosale

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.

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.

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

Comparing Accuracy of PET/MR vs. CECT in Assessment of Peritoneal Disease for Resectability in Patients With Ovarian Cancer or Highly Suspected Ovarian Cancer

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.

Will be analyzed using linear regression or generalized linear regression models where applicable.

Correlation between imaging and genomic data will be analyzed using linear regression or generalized linear regression models where applicable.

National Cancer Institute (NCI)

M.D. Anderson Cancer Center

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
PET/MR Versus CECT Scans in Imaging Patients With Ovarian Cancer or Highly Suspected Ovarian Cancer	NCT03965481	Malignant Ovari... Ovarian Carcino...	Dynamic Enhance... Magnetic Resona... Positron Emissi...	18 Years -	M.D. Anderson Cancer Center
PET/MR Versus CECT Scans in Imaging Patients With Ovarian Cancer or Highly Suspected Ovarian Cancer	NCT03965481	Malignant Ovari... Ovarian Carcino...	Dynamic Enhance... Magnetic Resona... Positron Emissi...	18 Years -	M.D. Anderson Cancer Center
PET/MR Versus CECT Scans in Imaging Patients With Ovarian Cancer or Highly Suspected Ovarian Cancer	NCT03965481	Malignant Ovari... Ovarian Carcino...	Dynamic Enhance... Magnetic Resona... Positron Emissi...	18 Years -	M.D. Anderson Cancer Center

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