Evaluation of Endometriosis With 18F-fluorofuranylnorprogesterone PET / MRI
Recruiting · NCT05480995 · Interventional (participants receive a specific treatment) · Lead sponsor: University of North Carolina, Chapel Hill
View the official record on ClinicalTrials.gov →Interventions studied
18F-fluorofuranylnorprogesterone PET / MRI
What this trial is about
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.
Who can take part
Age range
18 Years to 55 Years
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
1 location listed across 1 US state.
- University of North Carolina at Chapel Hill - Chapel Hill, North Carolina, United States