PET-CT vs. Integrated MR-PET Scanning of GYN Cancers

Status: Recruiting
Phase: Phase 0
Diagnosis: GYN: Endometrial/Uterine Cancer, GYN: Cervical Cancer, GYN: Ovarian, Fallopian, Peritoneal Cancer
NCT ID: NCT01779128 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 12-233

 

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.

 

Conducting Institutions:
Massachusetts General Hospital

Overall PI:
Michael Birrer, MD, PhD, Massachusetts General Hospital

Site-responsible Investigators:

Contacts:
Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100

Eligibility Criteria

Inclusion Criteria: - Histologically confirmed cervical, endometrial or ovarian cancer - Able to undergo extra-peritoneal or laparoscopic lymph node sampling - Suitable candidate for surgery Exclusion Criteria: - Previous pelvic or abdominal lymphadenectomy - Evidence of prior pelvic radiation therapy - Renal dysfunction - Electrical implants - Ferromagnetic implants - Pregnant or breastfeeding - Pre-existing medical conditions or claustrophobic reactions or any greater than normal potential for cardiac arrest as determined by treating oncologist - Unable to lie comfortably on a bed inside the scanner for 60 minutes as assessed by physical examination and medical history - Outside circumstances that interfere with the completion of the imaging studies or required follow-up
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