NCT04382911

Evaluation of Endometriosis With 18F-fluoroestradiol PET / MRI

Completed Phase 2 Results posted Last updated 30 May 2023

What this trial tests

Phase 2 trial testing 18F-fluoroestradiol in Endometriosis in 8 participants. Completed in 11 July 2022.

Timeline

7 August 2020

Primary endpoint
11 July 2022

11 July 2022

Quick facts

Lead sponsor	University of North Carolina, Chapel Hill
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	8
Start date	7 August 2020
Primary completion	11 July 2022
Estimated completion	11 July 2022
Sites	1 location across United States

Drugs / interventions tested

• 18F-fluoroestradiol — full drug profile →

Conditions studied

• Endometriosis — all drugs for Endometriosis →

Sponsor

University of North Carolina, Chapel Hill

Who can join

18 and older, female only, with Endometriosis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Sensitivity of FES PET/MRI for Evaluating Endometriosis (Percentage of Positive Scans) Primary · day of scan, up to 2 hours

The sensitivity of FES PET /MRI is defined as the ability of readers (radiologists) to detect endometriosis among those with histopathologically identified endometriosis in the entire cohort. Sensitivity is calculated by dividing the number of true cases of endometriosis by the overall number of patients with endometriosis identified using the research imaging. The sensitivity data can only be calculated upon completion of study imaging for all participants.

Group	Value	95% CI
18F-fluoroestradiol PET / MRI	67

Mean Standard Uptake Values (SUV-max) for 18F-fluoroestradiol PET / MRI Secondary · day of scan, up to 2 hours

The SUV-max is the maximum standardized uptake value for FES within the tissue.

Group	Value	95% CI
18F-fluoroestradiol PET / MRI	3.23	± 3.04

Adverse events — posted to ClinicalTrials.gov

Time frame: Assessed for 24 hours following the imaging procedure.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

18F-fluoroestradiol PET / MRI

Serious: 0/6 (0%)

Deaths: 0/6

Other adverse events (3 terms — click to expand)

Reaction	System	18F-fluoroestradiol PET / …
Fatigue	General disorders	—
Change in smell	General disorders	—
headache	General disorders	—

Data from ClinicalTrials.gov NCT04382911 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.