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PET/MRI in Endometrial Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05390021
Recruitment Status : Not yet recruiting
First Posted : May 25, 2022
Last Update Posted : May 25, 2022
Sponsor:
Information provided by (Responsible Party):
Onofrio A. Catalano, 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)


Condition or disease Intervention/treatment Phase
Cytoreductive Surgery Grade 3 Endometrial Endometrioid Adenocarcinoma High Grade Serous Carcinoma Endometrial Undifferentiated Carcinoma Endometrial Mixed Cell Adenocarcinoma Combination Product: PET/MRI with radiotracer ([18F]- fluorodeoxyglucose) and a gadolinium-based contrast agent Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 33 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Estimated Study Start Date : October 2022
Estimated Primary Completion Date : February 1, 2024
Estimated Study Completion Date : February 1, 2026

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Percentage of patients with a metastatic lesion noted on PET/MRI that have a true malignancy noted on surgical pathology of that lesion [ Time Frame: Baseline ]
    Sensitivity of PET/MRI to detect metastatic lesions

  2. Percentage of patients without any metastatic lesion noted on PET/MRI that do not have malignancy noted on surgical pathology [ Time Frame: Baseline ]
    Specificity of PET/MRI to detect abscence of metastatic lesions



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05390021


Contacts
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Contact: Onofrio Catalono, MD, PhD (617) 643-7920 ocatalano@mgh.harvard.edu

Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02115
Contact: Onofrio Catalano, MD, Ph.D    617-643-7920    ocatalano@mgh.harvard.edu   
Principal Investigator: Onofrio Catalano, MD, Ph.D         
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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Principal Investigator: Onofrio Catalono, MD, PhD Massachusetts General Hospital
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Responsible Party: Onofrio A. Catalano, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT05390021    
Other Study ID Numbers: 22-112
First Posted: May 25, 2022    Key Record Dates
Last Update Posted: May 25, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (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

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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
Additional relevant MeSH terms:
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Carcinoma
Adenocarcinoma
Carcinoma, Endometrioid
Cystadenocarcinoma, Serous
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Ovarian Neoplasms
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases
Cystadenocarcinoma
Neoplasms, Cystic, Mucinous, and Serous
Fluorodeoxyglucose F18
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action