PET/MRI in Endometrial Cancer

Diagnostic Performance of PET/MRI Versus Standard of Care Imaging (PET/CT and/or CT and/or PET) in Preoperative Women With Presumed Early-stage High Grade Endometrial Carcinoma

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)

Study Overview

• Status: Withdrawn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

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PET/MRI IN ENDOMETRIAL CANCER; PET/MRI in one study visit of approximately four hours	Combination product: PET/MRI with radiotracer ([18F]- fluorodeoxyglucose) and a gadolinium-based contrast agent; The research study procedures include a screening for eligibility and a single study visit. PET/MRI in one study visit of approximately four hours.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Investigators: Principal Investigator: Onofrio Catalono, MD, PhD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): March 30, 2024
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): February 1, 2026

Study Registration Dates

• First Submitted: May 18, 2022
• First Submitted That Met QC Criteria: May 21, 2022
• First Posted (Actual): May 25, 2022

Study Record Updates

• Last Update Posted (Actual): April 2, 2024
• Last Update Submitted That Met QC Criteria: April 1, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Uterine Neoplasms; Genital Neoplasms, Female; Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Cystadenocarcinoma; Neoplasms, Cystic, Mucinous, and Serous; Ovarian Neoplasms; Endometrial Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Carcinoma; Adenocarcinoma; Cystadenocarcinoma, Serous; Carcinoma, Endometrioid; Molecular Mechanisms of Pharmacological Action; Radiopharmaceuticals; Fluorodeoxyglucose F18
• Other Study ID Numbers: 22-112

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• IPD Sharing Time Frame: Data can be shared no earlier than 1 year following the date of publication
• IPD Sharing Access Criteria: Contact the Partners Innovations team at http://www.partners.org/innovation
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes