Clinical trial NCT05480995: Evaluation of Endometriosis With 18F-fluorofuranylnorprogesterone PET / MRI
Official title: Evaluation of Endometriosis With 18F-fluorofuranylnorprogesterone Positron Emission Tomography-Magnetic Resonance Imaging (PET / MRI)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Endometriosis
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2022-07-29
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Sensitivity of 18F-fluorofuranylnorprogesterone (FFNP) PET/MR for evaluating endometriosis
timeFrame: Upon completion of all study image data collection for all participants [approximately 1 year]
measure: Specificity of 18F-fluorofuranylnorprogesterone (FFNP) PET/MR for evaluating endometriosis
timeFrame: Upon completion of all study image data collection for all participants [approximately 1 year]
Secondary outcomes:
measure: Diagnostic accuracy of PET /MRI
timeFrame: Upon completion of all study image data collection for all participants [approximately 1 year]
measure: Correlation of uptake values (SUV-max) with Endometriosis Health Profile (EHP-30) scale controlling for covariates
timeFrame: Upon completion of all study image data collection for all participants [approximately 1 year]
measure: Correlation of uptake values (SUV-max) with pain level using a visual analog scale (VAS) controlling for covariates
timeFrame: Upon completion of all study image data collection for all participants [approximately 1 year]
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Jorge Oldan, MD
role: PRINCIPAL_INVESTIGATOR
References: