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Search / Trial NCT04382911

Evaluation of Endometriosis With 18F-fluoroestradiol PET / MRI

Launched by UNIVERSITY OF NORTH CAROLINA, CHAPEL HILL · May 6, 2020

Trial Information

Current as of July 25, 2025

Completed

Keywords

ClinConnect Summary

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.

Gender

FEMALE

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

About University Of North Carolina, Chapel Hill

The University of North Carolina at Chapel Hill (UNC) is a leading research institution renowned for its commitment to advancing health and science through innovative clinical trials. With a robust infrastructure that supports multidisciplinary collaboration, UNC conducts cutting-edge research across various fields, including medicine, public health, and biomedical sciences. The university is dedicated to improving patient care and health outcomes by translating its research findings into practical applications. UNC’s clinical trials are designed to evaluate new therapies, interventions, and technologies, ensuring that they meet the highest ethical and scientific standards while fostering a culture of inclusivity and community engagement.

Locations

Chapel Hill, North Carolina, United States

Patients applied

0 patients applied

Trial Officials

Jorge Oldan, MD

Principal Investigator

University of North Carolina, Chapel Hill

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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