Evaluation of Endometriosis With 18F-fluorofuranylnorprogesterone Positron Emission Tomography-Magnetic Resonance Imaging (PET / MRI)

22-1175

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.

2023-01-17

2024-12-01

2024-12-01

Recruiting

Early phase I

24

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 24, 'type': 'ESTIMATED'}}

2024-02-20