18F-fluorofuranylnorprogesterone PET / MRI for Endometrioma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
University of North Carolina at Chapel Hill, Chapel Hill, NC
Endometrioma
18F-fluorofuranylnorprogesterone PET / MRI - Drug
Eligibility
18 - 65
Female
What conditions do you have?
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Study 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.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 3 Secondary · Reporting Duration: Upon completion of all study image data collection for all participants [approximately 1 year]

Year 1
Correlation of uptake values (SUV-max) with Endometriosis Health Profile (EHP-30) scale controlling for covariates
Correlation of uptake values (SUV-max) with pain level using a visual analog scale (VAS) controlling for covariates
Diagnostic accuracy of PET /MRI
Sensitivity of 18F-fluorofuranylnorprogesterone (FFNP) PET/MR for evaluating endometriosis
Specificity of 18F-fluorofuranylnorprogesterone (FFNP) PET/MR for evaluating endometriosis

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

1 Treatment Group

18F-fluorofuranylnorprogesterone PET / MRI
1 of 1
Experimental Treatment

24 Total Participants · 1 Treatment Group

Primary Treatment: 18F-fluorofuranylnorprogesterone PET / MRI · No Placebo Group · Phase 2

18F-fluorofuranylnorprogesterone PET / MRI
Drug
Experimental Group · 1 Intervention: 18F-fluorofuranylnorprogesterone PET / MRI · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: upon completion of all study image data collection for all participants [approximately 1 year]
Closest Location: University of North Carolina at Chapel Hill · Chapel Hill, NC
Photo of University of North Carolina at Chapel Hill  1Photo of University of North Carolina at Chapel Hill  2Photo of University of North Carolina at Chapel Hill  3
1999First Recorded Clinical Trial
0 TrialsResearching Endometrioma
429 CompletedClinical Trials

Eligibility Criteria

Age 18 - 65 · Female Participants · 5 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are female and childbearing age.
You are scheduled for planned operative laparoscopy with no hormone treatment for at least two cycles.
You have endometriosis as defined by a physician.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.