Evaluation of Endometriosis With 18F-fluoroestradiol PET / MRI

NCT ID: NCT04382911

Last Updated: 2023-05-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-07
• Study Completion Date: 2022-07-11

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

18F-fluoroestradiol PET / MRI

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

Group Type: EXPERIMENTAL

18F-fluoroestradiol

Intervention Type: DRUG

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

Interventions

18F-fluoroestradiol

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

Intervention Type: DRUG

Other Intervention Names

FES

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

North Carolina Translational and Clinical Sciences Institute

OTHER

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jorge Oldan, MD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

UNC Hospitals

Chapel Hill, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

20-0328

Identifier Type: -

Identifier Source: org_study_id