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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
Must not have
Previous pelvic or abdominal lymphadenectomy
Renal dysfunction
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group

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.
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.
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 below
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I can have a minor surgery to check my lymph nodes.
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My cancer is confirmed in the cervix, endometrium, or ovaries.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had lymph node surgery in my pelvis or abdomen.
Select...
I have kidney problems.
Select...
I cannot lie down comfortably for an hour due to my condition.
Select...
I have had radiation therapy in the pelvic area before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 study objectives
Determine Percentage of Participants in Whom MR/PET (relative to PET/CT) Detects Biopsy Proven Disease
Evaluate Additive Diagnostic Value of MRI Fusion

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
PET-CT
2014
N/A
~570
MR-PET
2015
N/A
~10

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
3,006 Previous Clinical Trials
13,307,182 Total Patients Enrolled
Michael Birrer, MD, PhDPrincipal InvestigatorMassachusetts General Hospital
1 Previous Clinical Trials
10,000 Total Patients Enrolled

Media Library

MR-PET Clinical Trial Eligibility Overview. Trial Name: NCT01779128 — Phase < 1
Cervical Cancer Research Study Groups: Experimental Arm
Cervical Cancer Clinical Trial 2023: MR-PET Highlights & Side Effects. Trial Name: NCT01779128 — Phase < 1
MR-PET 2023 Treatment Timeline for Medical Study. Trial Name: NCT01779128 — Phase < 1
~8 spots leftby Nov 2025
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