Evaluating a new imaging method for diagnosing endometriosis
Evaluation of Endometriosis With 18F-fluorofuranylnorprogesterone Positron Emission Tomography-Magnetic Resonance Imaging (PET / MRI)
This study is testing a new imaging method to see if it can help women with suspected endometriosis get a more accurate diagnosis before surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | Female |
| Sponsor | University of North Carolina, Chapel Hill Academic / other |
| Locations | 1 site (Chapel Hill, North Carolina) |
| Trial ID | NCT05480995 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the effectiveness of 18F-fluorofuranylnorprogesterone PET/MRI in diagnosing endometriosis by evaluating its sensitivity and specificity. A total of 24 female participants, aged 18 to 55, with clinically suspected endometriosis will be recruited for this prospective, single-center study. Participants will undergo the imaging procedure prior to planned operative laparoscopy, ensuring no hormone treatments have been administered for at least two cycles. The goal is to demonstrate the clinical utility of this imaging technique in accurately diagnosing endometriosis.
Who should consider this trial
Good fit: Ideal candidates are females aged 18-55 with clinically suspected endometriosis who are scheduled for operative laparoscopy.
Not a fit: Patients who are male, pregnant, or have a history of certain cancers will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more accurate and non-invasive method for diagnosing endometriosis, potentially leading to better patient outcomes.
How similar studies have performed: While this approach is innovative, similar imaging techniques have shown promise in other studies, but this specific method is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Chapel Hill, North Carolina
- University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Jorge Oldan, MD — University of North Carolina, Chapel Hill
- Study coordinator: Markeela Lipscomb, CCRC
- Email: markeela_lipscomb@med.unc.edu
- Phone: 919-843-3670
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.