PET/MRI in Endometrial Cancer

NCT05390021 | Withdrawn FDA Device

• 1 other identifier: 22-112
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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)

Conditions

Cytoreductive Surgery; Grade 3 Endometrial Endometrioid Adenocarcinoma; High Grade Serous Carcinoma; Endometrial Undifferentiated Carcinoma; Endometrial Mixed Cell Adenocarcinoma

Outcome Measures

Primary Outcomes (2)

• Percentage of patients with a metastatic lesion noted on PET/MRI that have a true malignancy noted on surgical pathology of that lesion

  Sensitivity of PET/MRI to detect metastatic lesions

  Baseline

• Percentage of patients without any metastatic lesion noted on PET/MRI that do not have malignancy noted on surgical pathology

  Specificity of PET/MRI to detect abscence of metastatic lesions

  Baseline

Study Arms (1)

PET/MRI IN ENDOMETRIAL CANCER

EXPERIMENTAL

PET/MRI in one study visit of approximately four hours

Combination Product: PET/MRI with radiotracer ([18F]- fluorodeoxyglucose) and a gadolinium-based contrast agent

Interventions

PET/MRI with radiotracer ([18F]- fluorodeoxyglucose) and a gadolinium-based contrast agent COMBINATION_PRODUCT

The research study procedures include a screening for eligibility and a single study visit. PET/MRI in one study visit of approximately four hours.

PET/MRI IN ENDOMETRIAL CANCER

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

MeSH Terms

Interventions

Fluorodeoxyglucose F18

Intervention Hierarchy (Ancestors)

Deoxyglucose; Deoxy Sugars; Carbohydrates

Study Officials

• Onofrio Catalono, MD, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 18, 2022
• First Posted: May 25, 2022
• Study Start: March 30, 2024
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2026
• Last Updated: April 2, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: Contact the Partners Innovations team at http://www.partners.org/innovation