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NCT05390021Withdrawn

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

Source: ClinicalTrials.gov · Last updated 2 Apr 2024

Reason given: Unable to enroll patients to study

Brief summary (registry, in English)

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)

Status (registry)
Withdrawn
Study type
Interventional
Enrollment
0 (actual)
First submitted
18 May 2022
Start date
30 Mar 2024
Primary completion date
1 Feb 2025
Lead sponsor
Massachusetts General Hospital
NCT number
NCT05390021

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • If research-related radiation exposure exceeds current Radiology Department guidelines (i.e., 50 mSv in the prior 12 months)
  • Perioperative liver transplantation period

Other illness

  • 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.
  • A history of chronic severe renal insufficiency (glomerular filtration rate <30 mL/min/1.73m2)

Lab values

  • 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)

Age

  • Subjects less than 18 years of age or greater than 85 years of age

Other

  • Weight greater than 300lbs (the PET/MRI table weight limit) or BMI > 33
  • Suffers from claustrophobia
  • 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

Who the study is looking for

  • 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,

Age in the registry: 18 years to 85 years · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.