CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 8 enrolled
Drug / intervention
18F-fluoroestradioldrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04382911
NCT04382911Phase 2Completed

Evaluation of Endometriosis With 18F-fluoroestradiol PET / MRI

University of North Carolina, Chapel Hill·interventional·Posted May 11, 2020·Updated May 30, 2023

In Brief

A Phase 2 clinical trial evaluating 18F-fluoroestradiol for Endometriosis. Completed, enrolled 8 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEndometriosis
CountriesUnited States

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedMay 11, 2020
Enrollment StartAug 7, 2020
Primary CompletionJul 11, 2022
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 6.1 years ago

Interventions

18F-fluoroestradioldrug

Patients will receive the FES tracer during a PET/MRI scan