Clinical trial NCT05390021: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: Cytoreductive Surgery
Grade 3 Endometrial Endometrioid Adenocarcinoma
High Grade Serous Carcinoma
Endometrial Undifferentiated Carcinoma
Endometrial Mixed Cell Adenocarcinoma
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2022-05-25
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Percentage of patients with a metastatic lesion noted on PET/MRI that have a true malignancy noted on surgical pathology of that lesion
timeFrame: Baseline
measure: Percentage of patients without any metastatic lesion noted on PET/MRI that do not have malignancy noted on surgical pathology
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Massachusetts General Hospital
name: Onofrio Catalono, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: