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

M.D. Anderson Cancer Center1 个研究点分布在 1 个国家目标入组 21 人2018年5月12日

概览

简要总结

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.

详细描述

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.

注册库

clinicaltrials.gov

开始日期

2018年5月12日

结束日期

2027年4月30日

最后更新

17天前

研究类型

Interventional

研究设计

Single Group

性别

Female

研究者

发起方

M.D. Anderson Cancer Center

责任方

Sponsor

入排标准

入选标准

•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.

排除标准

•Patients allergic to gadolinium.
•Patients who have eGRF \<
•Patients with cardiac pacers.
•Pediatric patients.
•Greater than 400 pounds in weight.
•Blood glucose (\> 200 mg/dl).
•Pregnant women.

研究组 & 干预措施

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.

干预措施: Dynamic Enhanced CT

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.

干预措施: Magnetic Resonance Imaging

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.

干预措施: Positron Emission Tomography

结局指标

主要结局

Lesion detection accuracy

时间窗: 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.