NCT04382911

Evaluation of Endometriosis With 18F-fluoroestradiol PET / MRI

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: University of North Carolina, Chapel Hill · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a prospective, one arm, single center study of 12 subjects with clinically suspected endometriosis to demonstrate FES PET-MRI's clinical utility for diagnosis of endometriosis. The primary objective is to evaluate the sensitivity and specificity of 18F-fluoroestradiol (FES) PET/MRI for evaluating endometriosis. Secondary objectives include comparing PET to conventional MRI, using histopathology from laparotomy as the gold standard and evaluating association of uptake values (SUV-max) with Endometriosis Health profile -30 (EHP-30) and pain rating scales, controlling for covariates.

Conditions

• Endometriosis

Interventions

Type	Name	Description
DRUG	18F-fluoroestradiol	Patients will receive the FES tracer during a PET/MRI scan

Timeline

• Start date: 2020-08-07
• Primary completion: 2022-07-11
• Completion: 2022-07-11
• First posted: 2020-05-11
• Last updated: 2023-05-30
• Results posted: 2023-02-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study