Evaluation of Endometriosis With 18F-fluoroestradiol PET / MRI

20-0328

Purpose: The primary objective is to evaluate the sensitivity and specificity of 18F-fluoroestradiol (FES) PET/MRI for evaluating endometriosis. Participants: A total of 12 participants will be recruited from individuals with clinically suspected endometriosis who are scheduled for planned operative laparoscopy at the University of North Carolina at Chapel Hill (UNC). Procedures (methods): This is a prospective, one arm, single center study of 12 subjects with clinically suspected endometriosis to demonstrate FES PET/MR's clinical utility for diagnosis of endometriosis. This study will be an evaluation of the radiotracer, FES, which binds to estrogen receptors and has previously been used to study estrogen receptor expression in tumors, to detect endometriosis. Participants will undergo one FES PET/MR scan within 4 weeks prior to their scheduled surgery. Participants will also complete questionnaires regarding their condition, pain, and quality of life.

2020-08-07

2022-07-11

2022-07-11

Completed

Early phase I

8

Inclusion Criteria: * Age 18 or older * Female of childbearing age * Clinically suspected (symptomatic) endometriosis. * Scheduled for planned operative laparoscopy with no hormone treatment for at least two cycles * Able to provide informed consent or assent Exclusion Criteria: * Male * Institutionalized subject (prisoner or nursing home patient) * Known history of breast, ovarian or endometrial cancer. * Pregnant or breast-feeding women

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 8, 'type': 'ACTUAL'}}

2023-05-30