Evaluation of Endometriosis With 18F-fluoroestradiol PET / MRI

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Evaluation of Endometriosis With 18F-fluoroestradiol PET / MRI

Conditions
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Endometriosis

Intervention / Treatment
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* Drug: 18F-fluoroestradiol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 18F-fluoroestradiol PET / MRI<br>All enrolled subjects will receive the tracer and then have a PET/MRI scan. | Drug: 18F-fluoroestradiol<br>* Patients will receive the FES tracer during a PET/MRI scan<br>* Other names: FES;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 |