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MR-PET vs PET-CT Scanning for Gynecological Cancers
Phase < 1
Waitlist Available
Led By Michael Birrer, MD, PhD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Able to undergo extra-peritoneal or laparoscopic lymph node sampling
Histologically confirmed cervical, endometrial or ovarian cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial will enroll up to 50 participants with various types of cancer. The investigators hope that the use of this new scanner will help doctors better detect, diagnose, and stage various types of cancer.
Who is the study for?
This trial is for individuals with confirmed cervical, endometrial, or ovarian cancer who are suitable for surgery and can undergo lymph node sampling. It's not for those with kidney issues, electrical or ferromagnetic implants, prior pelvic radiation therapy, pregnancy/breastfeeding, certain medical conditions including claustrophobia or high cardiac arrest risk.Check my eligibility
What is being tested?
The study compares two imaging methods: MR-PET (a new combined MRI and PET scan) versus the standard PET-CT scan to see which provides better tumor images in gynecological cancers. The MR-PET scanner is FDA-approved but uses some experimental software.See study design
What are the potential side effects?
Potential side effects may include discomfort from lying still during scans and reactions to contrast dyes used in imaging. There's also a small exposure to radiation similar to x-rays during PET scans.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can have a minor surgery to check my lymph nodes.
Select...
My cancer is confirmed in the cervix, endometrium, or ovaries.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Evaluate Diagnostic Sensitivity and Specificity of Preoperative MR/PET vs. FDG-PET/CT
Evaluate Diagnostic Sensitivity and Specificity of Preoperative MR/PET vs. PET/CT
Secondary outcome measures
Determine Percentage of Participants in Whom MR/PET (relative to PET/CT) Detects Biopsy Proven Disease
Evaluate Additive Diagnostic Value of MRI Fusion
Trial Design
1Treatment groups
Experimental Treatment
Group I: Experimental ArmExperimental Treatment2 Interventions
PET/CT Scan MR-PET Scan
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MR-PET
2015
N/A
~10
PET-CT
2014
N/A
~570
Find a Location
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
2,928 Previous Clinical Trials
13,198,255 Total Patients Enrolled
Michael Birrer, MD, PhDPrincipal InvestigatorMassachusetts General Hospital
1 Previous Clinical Trials
10,000 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had lymph node surgery in my pelvis or abdomen.I have kidney problems.I can have a minor surgery to check my lymph nodes.My cancer is confirmed in the cervix, endometrium, or ovaries.I cannot lie down comfortably for an hour due to my condition.I have had radiation therapy in the pelvic area before.I am fit for surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Experimental Arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any current openings for participation in this clinical experiment?
"According to the clinicaltrials.gov listing, this research project is not presently seeking volunteers. The trial was originally posted in March 2013 and last edited on January 28th of that same year. Nevertheless, 837 other medical trials are currently accepting applicants at this time."
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