Evaluation of Endometriosis With 18F-fluorofuranylnorprogesterone PET / MRI

NCT ID: NCT05480995

Last Updated: 2026-01-12

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-17

Study Completion Date

2026-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Endometriosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

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.

Group Type EXPERIMENTAL

18F-fluorofuranylnorprogesterone PET / MRI

Intervention Type DRUG

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

Countries

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United States

Central Contacts

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Markeela Lipscomb, CCRC

Role: CONTACT

919-843-3670

Hannah Mignosa-Martin

Role: CONTACT

984-215-4963

Facility Contacts

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Markeela Lipscomb, CCRC

Role: primary

919-843-3670

Hannah Mignosa-Martin

Role: backup

984-215-4963

Other Identifiers

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1P01HD106485-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

22-1175

Identifier Type: -

Identifier Source: org_study_id

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