NCT05480995PHASE2Recruiting
Evaluation of Endometriosis With 18F-fluorofuranylnorprogesterone PET / MRI
University of North Carolina, Chapel Hill
Start Date
1/17/2023
Completion Date
8/1/2026
Summary
Purpose: The aim of this study is to assess the sensitivity and specificity of FFNP PET/MRI for diagnosis of endometriosis. Participants: A total of 24 participants will be recruited from individuals with clinically suspected endometriosis. Procedures (methods): This is a prospective, one arm, single center study of 24 subjects with clinically suspected endometriosis to demonstrate FFNP PET-MRI's clinical utility for diagnosis of endometriosis.
Eligibility Criteria
Age Range: 18 years to 55 years
Inclusion Criteria
* Age 18 or older
* Female of childbearing age (18-55 years)
* Clinically suspected (symptomatic) endometriosis as defined by referring physician (this would also include endometriomas as other disease may be present).
* Scheduled for planned operative laparoscopy with no hormone treatment for at least two cycles
* Able to provide informed consent
Exclusion Criteria
* Male
* Institutionalized subject (prisoner or nursing home patient)
* Known history of breast, ovarian or endometrial cancer.
* Pregnant or breast-feeding women
* Chronic progestin-containing medications or Gonadotropin-releasing hormone (GnRH) analogues in the last 10-16 days (or 2 cycles in the case of GnRH analogues as these are dosed monthly) or inability to discontinue these medications
* Allergy to gadolinium contrast or Glomerular Filtration Rate (GFR) below 30 ml/min.
Interventions
DRUG
18F-fluorofuranylnorprogesterone PET / MRI
Conditions
Endometriosis
Locations
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina 27599
United States