PET/MRI versus Standard of Care Imaging for the Detection of Metastases in Stage I High Grade Endometrial Cancer

Status: withdrawn

This clinical trial tests whether positron emission tomography (PET)/magnetic resonance imaging (MRI) works more effectively than standard of care PET/computed tomography (CT) scan, CT scan, or PET scan in detecting metastases in patients with stage I high grade endometrial cancer. PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of tracer that certain cancers take up, allowing it to be seen on imaging. MRI is an imaging technique that uses radiofrequency waves and a strong magnetic field to provide detailed pictures of internal organs and tissues that is valuable for the diagnosis of cancer. CT utilizes x-rays that traverse body from the outside. CT images provide an exact outline of organs and potential inflammatory tissue where it occurs in patient’s body. PET/MRI may provide better imaging quality and detection of metastases in high-risk endometrial cancer which may prove to be beneficial to the medical care of others in the future.

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
They 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/1.73m^2. If the patient has a history of acute renal failure but their glomerular filtration rate (GFR) as recovered to above 30, then they are eligible for the trial

Exclusion Criteria

Weight greater than 300 pounds (lbs) (the PET/MRI table weight limit) or body mass index (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 human chorionic gonadotropin [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/1.73m^2)
Perioperative liver transplantation period

PRIMARY OBJECTIVES:

I. To compare the sensitivity and specificity of positron emission tomography (PET)/magnetic resonance imaging (MRI) to standard of care preoperative imaging (PET/computed tomography [CT] and/or CT and/or PET) in the detection of lymph node involvement and metastases in other organs in women with high-risk endometrial carcinoma.

II. Will perform an exploratory analysis examining various imaging biomarkers from PET or magnetic resonance imaging (MRI) or PET/MRI which might predict occurrence of distant metastases, tumor heterogeneity, or grade/histology at final pathology.

OUTLINE:

Patients receive fludeoxyglucose F-18 intravenously (IV) and gadolinium IV and undergo a PET/CT scan, attenuation correction (AC)-only PET scan, or a CT scan followed by a PET/MRI on study.

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PET/MRI versus Standard of Care Imaging for the Detection of Metastases in Stage I High Grade Endometrial Cancer

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