PET/MRI in Endometrial Cancer

Not Applicable

Withdrawn

• Conditions: Grade 3 Endometrial Endometrioid Adenocarcinoma; High Grade Serous Carcinoma; Endometrial Undifferentiated Carcinoma; Endometrial Mixed Cell Adenocarcinoma; Cytoreductive Surgery
• Interventions: Combination Product: PET/MRI with radiotracer ([18F]- fluorodeoxyglucose) and a gadolinium-based contrast agent

• Registration Number: NCT05390021
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

This study is investigating if positron emission tomography (PET)/Magnetic resonance imaging (MRI) is more effective than the currently used imaging modalities (computed tomography \[CT\], or PET/CT) for high-risk endometrial cancer.

The name of the intervention involved in this study is:

Positron Emission Tomography/Magnetic Resonance Imaging (PET/MRI)

Detailed Description

This research study involves undergoing a diagnostic imaging procedure called positron emission tomography/magnetic resonance imaging (PET/MRI). This type of scan uses a powerful magnet and a special drug that emits a small but detectable amount of radiation to show detailed images of tumors. This study, will examine the diagnostic effectiveness of positron emission tomography/magnetic resonance imaging (PET/MRI), which will be the intervention. The study will compare the results of this scan to either the computed tomography (CT) or PET/CT that participants would normally undergo as a standard of care for high-risk endometrial cancer.

The research study procedures include a screening for eligibility and a single study visit.

* Participants will undergo the PET/MRI in one study visit of approximately four hours.

* It is expected that about thirty-three (33) people will take part in this research study.

The U.S. Food and Drug Administration (FDA) has approved the PET/MRI scanner as a diagnostic modality option for indications that include for high-risk endometrial cancer.

Study Timeline

• Study First Submitted: 2022-05-18
• Study First Submitted QC: 2022-05-21
• Study First Posted: 2022-05-25
• Study Start: 2024-03-30
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-01
• Last Update Posted: 2024-04-02
• Primary Completion: 2025-02-01
• Study Completion: 2026-02-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

• Women aged 18-85 years old with an endometrial biopsy-confirmed diagnosis of either grade 3 endometrioid, serous, carcinosarcoma, undifferentiated or mixed cell carcinoma
• Must have presumed stage I disease, i.e., no symptoms suggesting disease outside of the uterus (weight loss, early satiety, bloating, changes in bowel movement, etc.)
• Planning to undergo cytoreductive surgery with a Gynecologic oncologist employed by Massachusetts General Hospital
• No previous history of chronic severe renal insufficiency and a glomerular filtration rate of >30 mL/min/1.73m2. If the patient has a history of acute renal failure but their GFR as recovered to above 30,

Exclusion Criteria

• Weight greater than 300lbs (the PET/MRI table weight limit) or BMI > 33
• Subjects less than 18 years of age or greater than 85 years of age
• Has Electrical implants, such as cardiac pacemakers or perfusion pumps
• Has Ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial hearts, prosthetic heart valves that are not compatible with the gradient maps of our scanners, metal fragments, shrapnel, metallic tattoos anywhere on the body, tattoos near the eye, or steel implants not compatible with a 3 Tesla MR.
• Is actively anticipating being pregnant or breastfeeding (a negative STAT quantitative serum hCG pregnancy test is required on the day of the scan before the subject can participate)
• Suffers from claustrophobia
• If research-related radiation exposure exceeds current Radiology Department guidelines (i.e., 50 mSv in the prior 12 months)
• Is unable to lie comfortably on a bed inside the PET/MRI bore as assessed by physical examination and medical history (e.g., back pain, arthritis)
• Subject is under the direct professional supervision of the principal investigator
• A history of chronic severe renal insufficiency (glomerular filtration rate <30 mL/min/1.73m2)
• Perioperative liver transplantation period

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PET/MRI IN ENDOMETRIAL CANCER	PET/MRI with radiotracer ([18F]- fluorodeoxyglucose) and a gadolinium-based contrast agent	PET/MRI in one study visit of approximately four hours

Primary Outcome Measures

Name	Time	Method
Percentage of patients without any metastatic lesion noted on PET/MRI that do not have malignancy noted on surgical pathology	Baseline	Specificity of PET/MRI to detect abscence of metastatic lesions
Percentage of patients with a metastatic lesion noted on PET/MRI that have a true malignancy noted on surgical pathology of that lesion	Baseline	Sensitivity of PET/MRI to detect metastatic lesions