Evaluation of Endometriosis With 18F-fluorofuranylnorprogesterone PET / MRI
NCT ID: NCT05480995
Last Updated: 2026-01-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
24 participants
INTERVENTIONAL
2023-01-17
2026-08-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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18F-fluorofuranylnorprogesterone PET / MRI
All enrolled subjects will receive the tracer and then have a PET/MRI scan.
18F-fluorofuranylnorprogesterone PET / MRI
Subjects will receive a PET/MRI with 18F-fluorofuranylnorprogesterone tracer
Interventions
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18F-fluorofuranylnorprogesterone PET / MRI
Subjects will receive a PET/MRI with 18F-fluorofuranylnorprogesterone tracer
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
55 Years
FEMALE
No
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
University of North Carolina, Chapel Hill
OTHER
Responsible Party
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Principal Investigators
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Jorge Oldan, MD
Role: PRINCIPAL_INVESTIGATOR
University of North Carolina, Chapel Hill
Locations
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University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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22-1175
Identifier Type: -
Identifier Source: org_study_id
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