Evaluation of Endometriosis With 18F-fluorofuranylnorprogesterone PET / MRI

Endometriosis Clinical Trial

Official title:

Evaluation of Endometriosis With 18F-fluorofuranylnorprogesterone Positron Emission Tomography-Magnetic Resonance Imaging (PET / MRI)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05480995
• Other study ID #: 22-1175
• Secondary ID: 1P01HD106485-01
• Status: Recruiting
• Phase: Phase 2
• Start date: January 17, 2023
• Est. completion date: December 2024

Study information

• Verified date: February 2024
• Source: University of North Carolina, Chapel Hill
• Contact: Markeela Lipscomb, CCRC
• Phone: 919-843-3670
• Email: markeela_lipscomb[@]med.unc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Endometriosis

Intervention

Drug:
• 18F-fluorofuranylnorprogesterone PET / MRI
Subjects will receive a PET/MRI with 18F-fluorofuranylnorprogesterone tracer

Locations

Country	Name	City	State
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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]
Primary	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	Diagnostic accuracy of PET /MRI	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).	Upon completion of all study image data collection for all participants [approximately 1 year]
Secondary	Correlation of uptake values (SUV-max) with Endometriosis Health Profile (EHP-30) scale controlling for covariates	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.	Upon completion of all study image data collection for all participants [approximately 1 year]
Secondary	Correlation of uptake values (SUV-max) with pain level using a visual analog scale (VAS) controlling for covariates	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.	Upon completion of all study image data collection for all participants [approximately 1 year]