Phase 2 N=8 Diagnostic

Evaluation of Endometriosis With 18F-fluoroestradiol PET / MRI

Endometriosis

Bottom Line

View on ClinicalTrials.gov: NCT04382911 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2023

Primary outcome: Primary: Sensitivity of FES PET/MRI for Evaluating Endometriosis (Percentage of Positive Scans) — 67 percentage of positive scans — p=0.317

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: 18F-fluoroestradiol (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: University of North Carolina, Chapel Hill
Primary completion: Jul 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Sensitivity of FES PET/MRI for Evaluating Endometriosis (Percentage of Positive Scans)	67	0.317
PRIMARY Specificity of FES PET/MRI for Evaluating Endometriosis (Percentage of Negative Scans)	—	—
SECONDARY Correlation of the FES PET/MRI Specificity to Conventional MRI	—	—
SECONDARY Mean Standard Uptake Values (SUV-max) for 18F-fluoroestradiol PET / MRI	3.23	0.24

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04382911). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.