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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

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Conditions

Endometriosis

Locations

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina 27599

United States