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

Study Description

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Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Cervical Cancer; Endometrial Cancer; Ovarian Cancer	Procedure: PET-CT; Procedure: MR-PET	Early Phase 1

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Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	100 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Diagnostic
Official Title:	Comparing Preoperative PET-CT With Integrated MR-PET Scanning of Gynecologic Cancers
Study Start Date :	March 2013
Estimated Primary Completion Date :	March 2015

Arms and Interventions

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Arm	Intervention/treatment
Experimental: Experimental Arm; PET/CT Scan MR-PET Scan	Procedure: PET-CT Procedure: MR-PET

Outcome Measures

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Primary Outcome Measures :

1. Evaluate Diagnostic Sensitivity and Specificity of Preoperative MR/PET vs. PET/CT [ Time Frame: 2 years ]
   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.
2. Evaluate Diagnostic Sensitivity and Specificity of Preoperative MR/PET vs. FDG-PET/CT [ Time Frame: 2 years ]
   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

Secondary Outcome Measures :

1. Evaluate Additive Diagnostic Value of MRI Fusion [ Time Frame: 2 years ]
   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.
2. Determine Percentage of Participants in Whom MR/PET (relative to PET/CT) Detects Biopsy Proven Disease [ Time Frame: 2 years ]
   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.

Eligibility Criteria

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

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

Contacts and Locations

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Contacts

Contact: Michael Birrer, MD, PhD	6177261941	mbirrer@partners.org

Locations

United States, Massachusetts
Massachusetts General Hospital	Not yet recruiting
Boston, Massachusetts, United States, 02115
Contact: Michael Birrer, MD, PhD 617-726-1941 mbirrer@partners.org
Principal Investigator: Michael Birrer, MD, PhD

Sponsors and Collaborators

Massachusetts General Hospital

Investigators

Principal Investigator:	Michael Birrer, MD, PhD	Massachusetts General Hospital

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Michael J. Birrer,M.D.,Ph.D., Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT01779128 History of Changes
Other Study ID Numbers:	12-233
First Posted:	January 30, 2013
Last Update Posted:	January 30, 2013
Last Verified:	January 2013

Additional relevant MeSH terms:

Uterine Cervical Neoplasms; Endometrial Neoplasms; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms	Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female