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PET/MRI Imaging for Endometrial Cancer

N/A
Waitlist Available
Led By Onofrio Catalono, 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
Women aged 18-85 years old with an endometrial biopsy-confirmed diagnosis of either grade 3 endometrioid, serous, carcinosarcoma, undifferentiated or mixed cell carcinoma
Planning to undergo cytoreductive surgery with a Gynecologic oncologist employed by Massachusetts General Hospital
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline
Awards & highlights

Study Summary

This trial is investigating whether PET/MRI is more effective than the currently used imaging modalities (CT, or PET/CT) for high-risk endometrial cancer.

Who is the study for?
This trial is for women aged 18-85 with certain high-risk endometrial cancers, presumed to be in early stage, and planning surgery at Massachusetts General Hospital. They must have proper kidney function. It excludes those over 300lbs or BMI >33, with specific implants, claustrophobia, excessive prior radiation exposure, severe renal issues or under the investigator's care.Check my eligibility
What is being tested?
The study tests if PET/MRI scans using a radiotracer and contrast agent are better than current CT or PET/CT imaging for detecting high-risk endometrial cancer before surgery.See study design
What are the potential side effects?
Possible side effects include reactions to the radiotracer or contrast agent like nausea or rash; discomfort from lying still during scanning; anxiety due to confinement in the scanner space (claustrophobia).

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a woman aged 18-85 with a specific type of uterine cancer confirmed by biopsy.
Select...
I plan to have surgery to reduce tumor size with a specialist at Massachusetts General Hospital.

Timeline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of patients with a metastatic lesion noted on PET/MRI that have a true malignancy noted on surgical pathology of that lesion
Percentage of patients without any metastatic lesion noted on PET/MRI that do not have malignancy noted on surgical pathology

Side effects data

From 2015 Phase 2 trial • 59 Patients • NCT01146054
29%
Anemia
29%
Lymphocyte count decreased
27%
Anorexia
27%
Fatigue
24%
Abdominal Pain
12%
Nausea
10%
Platelet Count Decreased
8%
Dyspepsia
6%
Constipation
2%
Duodenal hemorrhage
2%
Duodenal Ulcer
2%
Dehydration
2%
Sepsis
2%
Duodenal Fistula
100%
80%
60%
40%
20%
0%
Study treatment Arm
SBRT and Gemzar

Trial Design

1Treatment groups
Experimental Treatment
Group I: PET/MRI IN ENDOMETRIAL CANCERExperimental Treatment1 Intervention
PET/MRI in one study visit of approximately four hours

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,945 Previous Clinical Trials
13,203,878 Total Patients Enrolled
Onofrio Catalono, MD, PhDPrincipal InvestigatorMassachusetts General Hospital

Media Library

PET/MRI with radiotracer ([18F]- fluorodeoxyglucose) and a gadolinium-based contrast agent Clinical Trial Eligibility Overview. Trial Name: NCT05390021 — N/A
Cytoreductive Surgery Research Study Groups: PET/MRI IN ENDOMETRIAL CANCER
Cytoreductive Surgery Clinical Trial 2023: PET/MRI with radiotracer ([18F]- fluorodeoxyglucose) and a gadolinium-based contrast agent Highlights & Side Effects. Trial Name: NCT05390021 — N/A
PET/MRI with radiotracer ([18F]- fluorodeoxyglucose) and a gadolinium-based contrast agent 2023 Treatment Timeline for Medical Study. Trial Name: NCT05390021 — N/A
~0 spots leftby Feb 2025
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