Evaluation of Endometriosis With 18F-fluoroestradiol PET / MRI

NCT04382911 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 20-0328
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometriosis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Correlation of the FES PET/MRI Specificity to Conventional MRI

  day of scan, up to 2 hours

• Mean Standard Uptake Values (SUV-max) for 18F-fluoroestradiol PET / MRI

  day of scan, up to 2 hours

Study Arms (1)

18F-fluoroestradiol PET / MRI

EXPERIMENTAL

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

Drug: 18F-fluoroestradiol

Interventions

18F-fluoroestradiol DRUG

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

Also known as: FES

18F-fluoroestradiol PET / MRI

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Male
• Institutionalized subject (prisoner or nursing home patient)
• Known history of breast, ovarian or endometrial cancer.
• Pregnant or breast-feeding women

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• North Carolina Translational and Clinical Sciences Institute: collaborator

Study Sites (1)

UNC Hospitals

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Results Point of Contact

• Title: Director, Clinical Research, Department of Radiology
• Organization: University of North Carolina at Chapel Hill

rad_research@med.unc.edu

919-966-4997

Study Officials

• Jorge Oldan, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2020
• First Posted: May 11, 2020
• Study Start: August 7, 2020
• Primary Completion: July 11, 2022
• Study Completion: July 11, 2022
• Last Updated: May 30, 2023
• Results First Posted: February 9, 2023

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 9 to 36 months following publication
• 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.

Locations

US (1)