Evaluation of Endometriosis With 18F-fluorofuranylnorprogesterone PET / MRI

Part of paid clinical trials in Chapel Hill, North Carolina.

Sponsor
University of North Carolina, Chapel Hill
Study ID
NCT05480995
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 55 Years
Healthy Volunteers
Not accepted

Interventions

  • 18F-fluorofuranylnorprogesterone PET / MRI — DRUG
    Subjects will receive a PET/MRI with 18F-fluorofuranylnorprogesterone tracer

Study Details

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 Dates

Start date
Jan 17, 2023
Status verified
Jan 2026
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
24 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: 18F-fluorofuranylnorprogesterone PET / MRI
    All enrolled subjects will receive the tracer and then have a PET/MRI scan.

Primary Outcome Measure

Sensitivity of 18F-fluorofuranylnorprogesterone (FFNP) PET/MR for evaluating endometriosis [ Time Frame: Upon completion of all study image data collection for all participants [approximately 1 year] ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of North Carolina at Chapel HillChapel HillNorth Carolina27599
Markeela Lipscomb, CCRC
[email protected]
919-843-3670
Hannah Mignosa-Martin
[email protected]
984-215-4963
Jorge Oldan, MD (PRINCIPAL_INVESTIGATOR)
Yueh Lee, MD, PhD (SUB_INVESTIGATOR)
Steven Young, MD (SUB_INVESTIGATOR)
Erin Carey, MD (SUB_INVESTIGATOR)
Kristen Olinger, MD (SUB_INVESTIGATOR)
Lauren Burke, MD (SUB_INVESTIGATOR)
Lauren Schiff, MD (SUB_INVESTIGATOR)
Robert Huynh, PharmD (SUB_INVESTIGATOR)

Find similar trials in Chapel Hill, NC

By condition
Endometriosis
By specialty
Women's healthFertility
By research site
University of North Carolina at Chapel Hill· Chapel Hill, NC

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