Evaluation of Endometriosis With 18F-fluorofuranylnorprogesterone PET / MRI

• Status: Not yet recruiting
• Trial end date: 2026-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of North Carolina, Chapel Hill
• Collaborator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Criteria

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.