PET-CT vs. Integrated MR-PET Scanning of GYN Cancers
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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 |
- 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.
| 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 |
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| Contact: Michael Birrer, MD, PhD | 6177261941 | mbirrer@partners.org |
| 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 | |
| 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:
|
Endometrial Neoplasms Uterine Cervical Neoplasms Ovarian Neoplasms Adenoma Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Neoplasms Uterine Diseases |
Genital Diseases, Female Uterine Cervical Diseases Endocrine Gland Neoplasms Ovarian Diseases Adnexal Diseases Endocrine System Diseases Gonadal Disorders Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
ClinicalTrials.gov processed this record on June 18, 2013