University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
NCT Number: NCT05480995
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.
This study is active but is not currently recruiting participants.
Notify Me18 year–55 year
Female
Interventional
Phase 2
Chapel Hill, North Carolina, 27599, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Subjects will receive a PET/MRI with 18F-fluorofuranylnorprogesterone tracer
Time frame: Upon completion of all study image data collection for all participants [approximately 1 year]
The sensitivity of FFNP PET /MR is defined as the ability of readers (radiologists) to correctly detect endometriosis in patients who have endometriosis.
Time frame: Upon completion of all study image data collection for all participants [approximately 1 year]
The specificity is similarly defined as the ability of readers to exclude endometriosis in patients who do not have it.
Time frame: Upon completion of all study image data collection for all participants [approximately 1 year]
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).
Time frame: Upon completion of all study image data collection for all participants [approximately 1 year]
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.
Time frame: Upon completion of all study image data collection for all participants [approximately 1 year]
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.
University of North Carolina, Chapel Hill
Other
Evaluation of Endometriosis With 18F-fluorofuranylnorprogesterone Positron Emission Tomography-Magnetic Resonance Imaging (PET / MRI)
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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