Evaluation of Endometriosis With 18F-fluoroestradiol PET / MRI

Endometriosis Clinical Trial

Official title:

Evaluation of Endometriosis With 18F-fluoroestradiol PET / MRI

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04382911
• Other study ID #: 20-0328
• Status: Completed
• Phase: Phase 2
• Start date: August 7, 2020
• Est. completion date: July 11, 2022

Study information

• Verified date: July 2022
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Purpose: The primary objective is to evaluate the sensitivity and specificity of 18F-fluoroestradiol (FES) PET/MRI for evaluating endometriosis.

Participants: A total of 12 participants will be recruited from individuals with clinically suspected endometriosis who are scheduled for planned operative laparoscopy at the University of North Carolina at Chapel Hill (UNC).

Procedures (methods): This is a prospective, one arm, single center study of 12 subjects with clinically suspected endometriosis to demonstrate FES PET/MR's clinical utility for diagnosis of endometriosis. This study will be an evaluation of the radiotracer, FES, which binds to estrogen receptors and has previously been used to study estrogen receptor expression in tumors, to detect endometriosis. Participants will undergo one FES PET/MR scan within 4 weeks prior to their scheduled surgery. Participants will also complete questionnaires regarding their condition, pain, and quality of life.

Description:

This is a prospective, one arm, single center study of 12 subjects with clinically suspected endometriosis to demonstrate FES PET-MRI's clinical utility for diagnosis of endometriosis. The primary objective is to evaluate the sensitivity and specificity of 18F-fluoroestradiol (FES) PET/MRI for evaluating endometriosis. Secondary objectives include comparing PET to conventional MRI, using histopathology from laparotomy as the gold standard and evaluating association of uptake values (SUV-max) with Endometriosis Health profile -30 (EHP-30) and pain rating scales, controlling for covariates.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: July 11, 2022
• Est. primary completion date: July 11, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age 18 or older

• Female of childbearing age

• Clinically suspected (symptomatic) endometriosis.

• Scheduled for planned operative laparoscopy with no hormone treatment for at least two cycles

• Able to provide informed consent or assent

Exclusion Criteria:

• Male

• Institutionalized subject (prisoner or nursing home patient)

• Known history of breast, ovarian or endometrial cancer.

• Pregnant or breast-feeding women

Related Conditions & MeSH terms

• Endometriosis

Intervention

Drug:
• 18F-fluoroestradiol
Patients will receive the FES tracer during a PET/MRI scan

Locations

Country	Name	City	State
United States	UNC Hospitals	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	North Carolina Translational and Clinical Sciences Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity of FES PET/MRI for Evaluating Endometriosis (Percentage of Positive Scans)	The sensitivity of FES PET /MRI is defined as the ability of readers (radiologists) to detect endometriosis among those with histopathologically identified endometriosis in the entire cohort. Sensitivity is calculated by dividing the number of true cases of endometriosis by the overall number of patients with endometriosis identified using the research imaging. The sensitivity data can only be calculated upon completion of study imaging for all participants.	day of scan, up to 2 hours
Primary	Specificity of FES PET/MRI for Evaluating Endometriosis (Percentage of Negative Scans)	The specificity of FES PET /MRI is defined as the ability of readers (radiologists) to detect that patients do not have endometriosis divided by the number of participants without endometriosis as defined histopathologically in the entire cohort. Specificity is calculated by dividing the number of true negative cases by the overall number of patients without endometriosis identified using the research imaging. The specificity data can only be calculated upon completion of study imaging for all participants.	day of scan, up to 2 hours
Secondary	Correlation of the FES PET/MRI Specificity to Conventional MRI	The investigators will use McNemar's test, constructing the 2x2 table among all patients with a surgical diagnosis of negative to compare specificity for FES PET/MRI (Outcome Measure 2) versus conventional MRI. The specificity of FES PET /MRI is defined as the ability of readers (radiologists) to detect that patients do not have endometriosis divided by the number of participants without endometriosis as defined histopathologically in the entire cohort. Specificity is calculated by dividing the number of true negative cases by the overall number of patients without endometriosis identified using the research imaging. The specificity data can only be calculated upon completion of study imaging for all participants.	day of scan, up to 2 hours
Secondary	Mean Standard Uptake Values (SUV-max) for 18F-fluoroestradiol PET / MRI	The SUV-max is the maximum standardized uptake value for FES within the tissue.	day of scan, up to 2 hours