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PET/MRI in Endometrial Cancer

Primary Purpose

Cytoreductive Surgery, Grade 3 Endometrial Endometrioid Adenocarcinoma, High Grade Serous Carcinoma

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PET/MRI with radiotracer ([18F]- fluorodeoxyglucose) and a gadolinium-based contrast agent
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cytoreductive Surgery

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PET/MRI IN ENDOMETRIAL CANCER

Arm Description

PET/MRI in one study visit of approximately four hours

Outcomes

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
Sensitivity of PET/MRI to detect metastatic lesions
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

Secondary Outcome Measures

Full Information

First Posted
May 18, 2022
Last Updated
March 21, 2023
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05390021
Brief Title
PET/MRI in Endometrial Cancer
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 30, 2023 (Anticipated)
Primary Completion Date
February 1, 2024 (Anticipated)
Study Completion Date
February 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cytoreductive Surgery, Grade 3 Endometrial Endometrioid Adenocarcinoma, High Grade Serous Carcinoma, Endometrial Undifferentiated Carcinoma, Endometrial Mixed Cell Adenocarcinoma

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PET/MRI IN ENDOMETRIAL CANCER
Arm Type
Experimental
Arm Description
PET/MRI in one study visit of approximately four hours
Intervention Type
Combination Product
Intervention Name(s)
PET/MRI with radiotracer ([18F]- fluorodeoxyglucose) and a gadolinium-based contrast agent
Intervention Description
The research study procedures include a screening for eligibility and a single study visit. PET/MRI in one study visit of approximately four hours.
Primary Outcome Measure Information:
Title
Percentage of patients with a metastatic lesion noted on PET/MRI that have a true malignancy noted on surgical pathology of that lesion
Description
Sensitivity of PET/MRI to detect metastatic lesions
Time Frame
Baseline
Title
Percentage of patients without any metastatic lesion noted on PET/MRI that do not have malignancy noted on surgical pathology
Description
Specificity of PET/MRI to detect abscence of metastatic lesions
Time Frame
Baseline

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Onofrio Catalono, MD, PhD
Phone
(617) 643-7920
Email
ocatalano@mgh.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Onofrio Catalono, MD, PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Onofrio Catalano, MD, Ph.D
Phone
617-643-7920
Email
ocatalano@mgh.harvard.edu
First Name & Middle Initial & Last Name & Degree
Onofrio Catalano, MD, Ph.D

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

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PET/MRI in Endometrial Cancer

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