PET-CT vs. Integrated MR-PET Scanning of GYN Cancers
This research study is an imaging pilot study. Imaging pilot studies explore the potential benefit of one imaging approach compared to another clinically accepted approach. Such studies serve to understand how feasible an approach may be and whether it is worth pursuing in formal and larger clinical trials. Researchers of this study believe that simultaneous Magnetic Resonance Imaging (MRI) and Positron Emission Tomography (PET) imaging will offer additional imaging information to improve cancer detection.
MRI and PET are two tests that allow us to take pictures of the body and "look inside" the body without surgery. The MRI scanner uses a powerful magnet to make a picture of the body. The PET scanner makes pictures by using special dyes that "light up" inside the body. PET scans use radiation, similar to the radiation in a standard x-ray. We routinely use both tests to diagnose various types of cancer. As of now, the combination of PET and computed tomography (CT) has been considered a standard of care imaging approach for various cancers.
Until recently, MRI and PET tests were done separately. Now there is a new type of test called MR-PET that combines both MRI and PET test results. This scanner uses both MRI and PET tests at the same time. We would like to find out if the MR-PET scanner can produce better and clearer images (pictures) of tumors and information about them inside of the body.
This new MR-PET scanner is approved by the US FDA. However, some of the computer programs that tell the machine how to acquire and combine the test results are new and experimental. Experimental means that some of the computer programs are not approved by the FDA. This means that they can only be used in research studies. The MR-PET scanner has been previously used in a few human participants.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Comparing Preoperative PET-CT With Integrated MR-PET Scanning of Gynecologic Cancers|
- Evaluate Diagnostic Sensitivity and Specificity of Preoperative MR/PET vs. PET/CT [ Time Frame: 2 years ] [ Designated as safety issue: No ]To evaluate the diagnostic sensitivity and specificity of preoperative MR/PET versus PET/CT imaging in identifying metastases to pelvic lymph nodes, abdominal lymph nodes, or beyond in participants with locoregionally advanced cervical carcinoma or high-risk endometrial cancer.
- Evaluate Diagnostic Sensitivity and Specificity of Preoperative MR/PET vs. FDG-PET/CT [ Time Frame: 2 years ] [ Designated as safety issue: No ]To evaluate the diagnostic sensitivity and specificity of preoperative MR/PET versus FDG-PET/CT imaging in identifying contralateral ovary involvement, metastases to peritoneum and distinguishing benign (e.g., endometriosis) from malignant lesions in all participants with ovarian cancer
- Evaluate Additive Diagnostic Value of MRI Fusion [ Time Frame: 2 years ] [ Designated as safety issue: No ]To evaluate the additive diagnostic value of MRI fusion (MR/PET) compared with PET scanning alone in the identification of metastases to pelvic (obturator, external iliac), abdomen (common iliac, para-aortic, and para-caval), and combined (all regions) lymph nodes in participants with locoregionally advanced cervical carcinoma, high-risk endometrial carcinoma or ovarian carcinoma.
- Determine Percentage of Participants in Whom MR/PET (relative to PET/CT) Detects Biopsy Proven Disease [ Time Frame: 2 years ] [ Designated as safety issue: No ]To determine the percentage of participants with locoregionally advanced cervical carcinoma, high-risk endometrial cancer, or ovarian carcinoma in whom MR/PET (relative to PET/CT) detects biopsy proven disease outside the abdominal or pelvic lymph nodes.
|Study Start Date:||March 2013|
|Estimated Primary Completion Date:||March 2015 (Final data collection date for primary outcome measure)|
Experimental: Experimental Arm
PET/CT Scan MR-PET Scan
|Procedure: PET-CT Procedure: MR-PET|
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01779128
|Contact: Michael Birrer, MD, PhDemail@example.com|
|United States, Massachusetts|
|Massachusetts General Hospital||Not yet recruiting|
|Boston, Massachusetts, United States, 02115|
|Contact: Michael Birrer, MD, PhD 617-726-1941 firstname.lastname@example.org|
|Principal Investigator: Michael Birrer, MD, PhD|
|Principal Investigator:||Michael Birrer, MD, PhD||Massachusetts General Hospital|