Evaluation of Endometriosis With 18F-fluorofuranylnorprogesterone PET / MRI

Recruiting now · Phase 2

Conditions studied: Endometriosis

In brief

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.

Key facts

Study ID

NCT05480995

Run by

University of North Carolina, Chapel Hill

People needed

24

Starts

2023-01-17

Expected to finish

2026-08-01

Last updated by the study team

2026-01-12

Who can join

Age: 18 and older, up to 55. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States (enrolling)

Full record on ClinicalTrials.gov

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