Evaluation of Endometriosis With 18F-fluoroestradiol PET / MRI

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 Overview

• Status: Completed
• Conditions: Endometriosis
• Intervention / Treatment: Drug: 18F-fluoroestradiol

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.

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • UNC Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 18F-fluoroestradiol PET / MRI; All enrolled subjects will receive the tracer and then have a PET/MRI scan.	Drug: 18F-fluoroestradiol; Patients will receive the FES tracer during a PET/MRI scan; Other Names: FES

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity of FES PET/MRI for Evaluating Endometriosis (Percentage of Positive Scans)	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.	day of scan, up to 2 hours
Specificity of FES PET/MRI for Evaluating Endometriosis (Percentage of Negative Scans)	The specificity of FES PET /MRI is defined as the ability of readers (radiologists) to detect that patients do not have endometriosis divided by the number of participants without endometriosis as defined histopathologically in the entire cohort. Specificity is calculated by dividing the number of true negative cases by the overall number of patients without endometriosis identified using the research imaging. The specificity data can only be calculated upon completion of study imaging for all participants.	day of scan, up to 2 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation of the FES PET/MRI Specificity to Conventional MRI	The investigators will use McNemar's test, constructing the 2x2 table among all patients with a surgical diagnosis of negative to compare specificity for FES PET/MRI (Outcome Measure 2) versus conventional MRI. The specificity of FES PET /MRI is defined as the ability of readers (radiologists) to detect that patients do not have endometriosis divided by the number of participants without endometriosis as defined histopathologically in the entire cohort. Specificity is calculated by dividing the number of true negative cases by the overall number of patients without endometriosis identified using the research imaging. The specificity data can only be calculated upon completion of study imaging for all participants.	day of scan, up to 2 hours
Mean Standard Uptake Values (SUV-max) for 18F-fluoroestradiol PET / MRI	The SUV-max is the maximum standardized uptake value for FES within the tissue.	day of scan, up to 2 hours

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: North Carolina Translational and Clinical Sciences Institute
• Investigators: Principal Investigator: Jorge Oldan, MD, University of North Carolina, Chapel Hill

Study record dates

Study Major Dates

• Study Start (Actual): August 7, 2020
• Primary Completion (Actual): July 11, 2022
• Study Completion (Actual): July 11, 2022

Study Registration Dates

• First Submitted: May 6, 2020
• First Submitted That Met QC Criteria: May 6, 2020
• First Posted (Actual): May 11, 2020

Study Record Updates

• Last Update Posted (Actual): May 30, 2023
• Last Update Submitted That Met QC Criteria: May 25, 2023
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Endometriosis
• Other Study ID Numbers: 20-0328

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
• IPD Sharing Time Frame: 9 to 36 months following publication
• IPD Sharing Access Criteria: The investigator who proposes to use the data has approval from an IRB, IEC, or REB, as applicable, and an executed data use/sharing agreement with UNC.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No