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

NCT01779128 | Unknown Early Phase 1 DMC

• 1 other identifier: 12-233
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Cancer; Endometrial Cancer; Ovarian Cancer

Outcome Measures

Primary Outcomes (2)

• Evaluate Diagnostic Sensitivity and Specificity of Preoperative MR/PET vs. PET/CT

  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 years

• Evaluate Diagnostic Sensitivity and Specificity of Preoperative MR/PET vs. FDG-PET/CT

  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

  2 years

Secondary Outcomes (2)

• Evaluate Additive Diagnostic Value of MRI Fusion

  2 years

• Determine Percentage of Participants in Whom MR/PET (relative to PET/CT) Detects Biopsy Proven Disease

  2 years

Study Arms (1)

Experimental Arm

EXPERIMENTAL

PET/CT Scan MR-PET Scan

Procedure: PET-CT; Procedure: MR-PET

Interventions

PET-CT PROCEDURE

Experimental Arm

MR-PET PROCEDURE

Experimental Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed cervical, endometrial or ovarian cancer
• Able to undergo extra-peritoneal or laparoscopic lymph node sampling
• Suitable candidate for surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Endometrial Neoplasms; Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Michael Birrer, MD, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Birrer, MD, PhD

CONTACT

6177261941; mbirrer@partners.org

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 28, 2013
• First Posted: January 30, 2013
• Study Start: March 1, 2013
• Primary Completion: March 1, 2015
• Last Updated: January 30, 2013

Record last verified: 2013-01

Locations

US (1)