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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2013 by Massachusetts General Hospital
Sponsor:
Information provided by (Responsible Party):
Michael J. Birrer,M.D.,Ph.D., Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01779128
First received: January 28, 2013
Last updated: NA
Last verified: January 2013
History: No changes posted
  Purpose

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 Intervention Phase
Cervical Cancer
Endometrial Cancer
Ovarian Cancer
Procedure: PET-CT
Procedure: MR-PET
Phase 0

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 100
Study Start Date: March 2013
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental Arm
PET/CT Scan MR-PET Scan
Procedure: PET-CT Procedure: MR-PET

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01779128

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

No publications provided

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
Study First Received: January 28, 2013
Last Updated: January 28, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Ovarian Neoplasms
Uterine Cervical Neoplasms
Adnexal Diseases
Endocrine Gland Neoplasms
Endocrine System Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms
Neoplasms by Site
Ovarian Diseases
Urogenital Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Uterine Neoplasms

ClinicalTrials.gov processed this record on November 20, 2014