Evaluation of Endometriosis With 18F-fluorofuranylnorprogesterone PET / MRI
2 other identifiers
interventional
24
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jan 2023
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 27, 2022
CompletedFirst Posted
Study publicly available on registry
July 29, 2022
CompletedStudy Start
First participant enrolled
January 17, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2026
January 12, 2026
January 1, 2026
3.5 years
July 27, 2022
January 9, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
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.
Upon completion of all study image data collection for all participants [approximately 1 year]
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.
Upon completion of all study image data collection for all participants [approximately 1 year]
Secondary Outcomes (3)
Diagnostic accuracy of PET /MRI
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
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
Upon completion of all study image data collection for all participants [approximately 1 year]
Study Arms (1)
18F-fluorofuranylnorprogesterone PET / MRI
EXPERIMENTALAll enrolled subjects will receive the tracer and then have a PET/MRI scan.
Interventions
Subjects will receive a PET/MRI with 18F-fluorofuranylnorprogesterone tracer
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jorge Oldan, MD
University of North Carolina, Chapel Hill
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 27, 2022
First Posted
July 29, 2022
Study Start
January 17, 2023
Primary Completion (Estimated)
August 1, 2026
Study Completion (Estimated)
August 1, 2026
Last Updated
January 12, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Beginning 9 months after and continuing for 36 months following publication
- Access Criteria
- The investigator who proposes to use the data has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.
Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with the University of North Carolina (UNC).