Evaluation of Endometriosis With 18F-fluorofuranylnorprogesterone PET / MRI

Recruitment Status
RECRUITING
(See Contacts and Locations)Verified December 2025 by University of North Carolina, Chapel Hill
Sponsor
University of North Carolina, Chapel Hill
Information Provided by (Responsible Party)
University of North Carolina, Chapel Hill
Clinicaltrials.gov Identifier
NCT05480995
Other Study ID Numbers:
22-1175
First Submitted
July 26, 2022
First Posted
July 28, 2022
Last Update Posted
January 11, 2026
Last Verified
December 2025

ClinicalTrials.gov processed this data on January 2026Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Endometriosis
Drug: 18F-fluorofuranylnorprogesterone PET / MRI

Study Design

Study TypeInterventional
Actual Enrollment24 participants
Design AllocationN/A
Interventional ModelSingle Group Assignment
MaskingNone (Open Label)
Primary PurposeDiagnostic
Official TitleEvaluation of Endometriosis With 18F-fluorofuranylnorprogesterone Positron Emission Tomography-Magnetic Resonance Imaging (PET / MRI)
Study Start DateJanuary 16, 2023
Actual Primary Completion Date2mos 2w from now
Actual Study Completion Date2mos 2w from now

Groups and Cohorts

Group/CohortIntervention/Treatment
18F-fluorofuranylnorprogesterone PET / MRI
All enrolled subjects will receive the tracer and then have a PET/MRI scan.
Drug: 18F-fluorofuranylnorprogesterone PET / MRI
Subjects will receive a PET/MRI with 18F-fluorofuranylnorprogesterone tracer

Outcome Measures

Primary Outcome Measures
  1. Sensitivity of 18F-fluorofuranylnorprogesterone (FFNP) PET/MR for evaluating endometriosis
    The sensitivity of FFNP PET /MR is defined as the ability of readers (radiologists) to correctly detect endometriosis in patients who have endometriosis.
  2. Specificity of 18F-fluorofuranylnorprogesterone (FFNP) PET/MR for evaluating endometriosis
    The specificity is similarly defined as the ability of readers to exclude endometriosis in patients who do not have it.
Secondary Outcome Measures
  1. Diagnostic accuracy of PET /MRI
    Diagnostic accuracy will be defined by the histologic presence of endometriosis at laparotomy or laparoscopy and/or by symptomatic improvement as defined surgically by the referring physician within 3 months of surgery (surgeon will make final determination).
  2. Correlation of uptake values (SUV-max) with Endometriosis Health Profile (EHP-30) scale controlling for covariates
    Diagnostic accuracy will be defined by the histologic presence of endometriosis at laparotomy or laparoscopy and/or by symptomatic improvement as defined surgically by the referring physician within 3 months of surgery (surgeon will make final determination). EHP-30 score is this is the arithmetic mean of 30 questions, each rated 0-100, about function and pain with endometriosis, where 0 indicates the best health status through to 100 worst health status. Scale scores for each scale are calculated from the total of the raw scores of each item in the scale divided by the maximum possible raw score of all the items in the scale, multiplied by 100. The investigators will implement a random effects linear regression model, modeling SUV-max as a function of EHP-30, while controlling for patient-level covariates (BMI, race, age). The investigators will include physician as a random effect to account for physician-level correlation.
  3. Correlation of uptake values (SUV-max) with pain level using a visual analog scale (VAS) controlling for covariates
    Diagnostic accuracy will be defined by the histologic presence of endometriosis at laparotomy or laparoscopy and/or by symptomatic improvement as defined surgically by the referring physician within 3 months of surgery (surgeon will make final determination). The pain intensity is assessed using a visual analogue scale (VAS), which is a horizontal line 100 mm in length. Subjects mark the VAS with a single vertical line to indicate their current pain level, with 0 mm representing "No Pain" and 100 mm representing "Worst Possible Pain". The investigators will implement a random effects linear regression model, modeling SUV-max as a function of the pain rating, while controlling for patient-level covariates (BMI, race, age). The investigators will include physician as a random effect to account for physician-level correlation.

Eligibility Criteria

Ages Eligible for Study(Adult)
Sexes Eligible for StudyFemale
Accepts Healthy VolunteersNo
Inclusion 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
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.

Contacts and Locations

Sponsors and CollaboratorsUniversity of North Carolina, Chapel Hill
Locations
University of North Carolina at Chapel Hill | Chapel Hill North Carolina, United States, 27599
Investigators
Principal Investigator: Jorge Oldan, MD, University of North Carolina, Chapel Hill