Evaluation of Endometriosis With 18F-fluorofuranylnorprogesterone PET / MRI
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 18F-fluorofuranylnorprogesterone PET / MRI.
- Who it may be relevant to
- Registry conditions: Endometriosis. Basic parameters: 18 years — 55 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of Endometriosis With 18F-fluorofuranylnorprogesterone Positron Emission Tomography-Magnetic Resonance Imaging (PET / MRI)
Overview
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.
Interventions
- Drug 18F-fluorofuranylnorprogesterone PET / MRI
Subjects will receive a PET/MRI with 18F-fluorofuranylnorprogesterone tracer
Primary outcome measures
- 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]]
- Specificity 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]]
Secondary outcome measures (3)
- Diagnostic accuracy of PET /MRI [Time frame: Upon completion of all study image data collection for all participants [approximately 1 year]]
- Correlation of uptake values (SUV-max) with Endometriosis Health Profile (EHP-30) scale controlling for covariates [Time frame: Upon completion of all study image data collection for all participants [approximately 1 year]]
- Correlation of uptake values (SUV-max) with pain level using a visual analog scale (VAS) controlling for covariates [Time frame: Upon completion of all study image data collection for all participants [approximately 1 year]]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 1 center
- University of North Carolina at Chapel Hill — Chapel Hill
Identifiers
NCT: NCT05480995 · 22-1175 · 1P01HD106485-01