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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline

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

Dyspepsia

Constipation

Duodenal hemorrhage

Duodenal Ulcer

Dehydration

Sepsis

Duodenal Fistula

100%

80%

60%

40%

20%

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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor

2,940 Previous Clinical Trials

13,200,568 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there specific criteria for enrollment into this research project?

"This medical trial is presently recruiting 33 adults aged 18-85 with a histologically confirmed diagnosis of grade 3 endometrioid, serous, carcinosarcoma, undifferentiated or mixed cell carcinoma. To be eligible for the study they must present with no outward signs of metastatic disease (weight loss etc.), receive cytoreductive surgery from Massachusetts General Hospital and have an adequate glomerular filtration rate (>30 mL/min/1.73m2). Even if there has been previous kidney damage which impacts GFR scores but it has since recovered to above 30mL/min then that patient may still"

Answered by AI

Are researchers actively seeking participants to join this experiment?

"According to clinicaltrials.gov, the study in question is not presently enrolling patients; it was initially posted on October 1st 2022 and most recently revised on May 21st 2022. However, there are still 3135 other medical trials actively recruiting participants at this time."

Answered by AI

Are geriatrics eligible for enrollment in this trial?

"The age range of patients that can enrol in this clinical trial is 18 to 85. There are 80 trials open to minors and 3111 studies specifically for those over the retirement age."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

PET/MRI in Endometrial Cancer

Onofrio A. Catalano, MD, PhD 2024. "PET/MRI in Endometrial Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05390021.