Evaluation of Endometriosis With 18F-fluoroestradiol PET / MRI

University of North Carolina (UNC)

Status and phase: Completed; Phase 2

Conditions: Endometriosis

Treatments: Drug: 18F-fluoroestradiol

Study type: Interventional

Funder types: Other

Identifiers

NCT04382911

20-0328

Details and patient eligibility

About

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.

Full 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.

Enrollment: 8 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

18F-fluoroestradiol PET / MRI

Experimental group

Description:

All enrolled subjects will receive the tracer and then have a PET/MRI scan.

Treatment:

Drug: 18F-fluoroestradiol