drugset / Trial / NCT04382911

Evaluation of Endometriosis With 18F-fluoroestradiol PET / MRI

NCT04382911

NaSingle-groupOpen-labelDiagnostic

Summary

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.

Timeline

Start
2020-08-07
Primary completion
2022-07-11
Completion
2022-07-11

Drugs

EvaluationDrugModalityDoseRoute
Subject F-18 16 Alpha-Fluoroestradiol Diagnostic / imaging agent

Indications