Evaluation of Endometriosis With 18F-fluoroestradiol PET / MRI
Trial Summary
What is the purpose of this trial?
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.
Research Team
Jorge Oldan, MD
Principal Investigator
University of North Carolina, Chapel Hill
Eligibility Criteria
Inclusion Criteria
Treatment Details
Interventions
- 18F-fluoroestradiol (Radiopharmaceutical)
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Who Is Running the Clinical Trial?
University of North Carolina, Chapel Hill
Lead Sponsor
Dr. Peggy P. McNaull
University of North Carolina, Chapel Hill
Chief Medical Officer
MD from Louisiana State University School of Medicine
Dr. Lynne Fiscus
University of North Carolina, Chapel Hill
Chief Executive Officer since 2020
MD from Georgetown University, MPH from UNC
North Carolina Translational and Clinical Sciences Institute
Collaborator
Dr. Nicholas Shaheen
North Carolina Translational and Clinical Sciences Institute
Chief Executive Officer
MD, MPH
Dr. John Buse
North Carolina Translational and Clinical Sciences Institute
Chief Medical Officer since 2020
MD, PhD