Evaluation of Endometriosis With 18F-fluoroestradiol PET / MRI
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Detailed 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 EHP-30 and pain rating scales, controlling for covariates.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 18F-fluoroestradiol PET / MRI All enrolled subjects will receive the tracer and then have a PET/MRI scan. |
Drug: 18F-fluoroestradiol
Patients will receive the FES tracer during a PET/MRI scan
Other Names:
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Outcome Measures
Primary Outcome Measures
- The sensitivity of FES PET/MR for evaluating endometriosis [Upon completion of all study image data collection for all participants [approximately 1 year]]
The sensitivity of FES PET /MR is defined as the ability of readers (radiologists) to detect endometriosis in patients. Diagnostic accuracy will be defined by the histologic presence of endometriosis and by symptomatic improvement as defined surgically by the referring physician within 3 months of surgery.
- The specificity of FES PET/MR for evaluating endometriosis [Upon completion of all study image data collection for all participants [approximately 1 year]]
The specificity of FES PET /MR is defined as the ability of readers (radiologists) to detect that patients do not have endometriosis. Diagnostic accuracy will be defined by the histologic presence of endometriosis and by symptomatic improvement as defined surgically by the referring physician within 3 months of surgery.
Secondary Outcome Measures
- Comparison of the PET sensitivity to conventional MRI, using histopathology from laparotomy as the gold standard. [Upon completion of all study image data collection for all participants [approximately 1 year]]
The investigators will use McNemar's test, constructing the 2x2 table among all patients with a surgical diagnosis of positive to compare sensitivity for PET versus conventional MRI. P-values <0.05 for the comparison of sensitivity will be construed as evidence that sensitivity differ between PET and conventional MRI. P-values >0.05 will be considered inconclusive.
- Comparison of PET specificity to conventional MRI, using histopathology from laparotomy as the gold standard. [Upon completion of all study image data collection for all participants [approximately 1 year]]
The investigators will use McNemar's test, constructing the 2x2 table among all patients with a surgical diagnosis of negative to compare specificity for PET versus conventional MRI. P-values <0.05 for the comparison of specificity will be construed as evidence that specificity differ between PET and conventional MRI. P-values >0.05 will be considered inconclusive.
- The correlation of standardized uptake values (SUV-max) with EHP-30, controlling for BMI, race, age, and physician. [Upon completion of all study image data collection for all participants [approximately 1 year]]
The Endometriosis Health Profile-30 (EHP-30), a quality of life questionnaire used in women with endometriosis. The EHP-30 includes questions related to pain, control and powerlessness, social support, emotional wellbeing, and self image. The purpose of the EHP is to indicate the extent of self-reported ill health on each domain measured. Therefore, each scale is standardized on a scale of 0 - 100, 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.
- The correlation of uptake values (SUV-max) with pain rating scales (visual analog scale - VAS), controlling for BMI, race, age, and physician. [Upon completion of all study image data collection for all participants [approximately 1 year]]
For the VAS, individuals will be given a 100mm scale and asked to draw a single vertical line corresponding to the level of pain where 0mm is no pain and 100mm is pain as bad as it possibly could be. This line will be measured and the result will be recorded in mm. 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age 18 or older
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Female of childbearing age
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Clinically suspected (symptomatic) endometriosis.
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Scheduled for planned operative laparoscopy with no hormone treatment for at least two cycles
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Able to provide informed consent or assent
Exclusion Criteria:
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Male
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Institutionalized subject (prisoner or nursing home patient)
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Known history of breast, ovarian or endometrial cancer.
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Pregnant or breast-feeding women
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | UNC Hospitals | Chapel Hill | North Carolina | United States | 27599 |
Sponsors and Collaborators
- University of North Carolina, Chapel Hill
- North Carolina Translational and Clinical Sciences Institute
Investigators
- Principal Investigator: Jorge Oldan, MD, University of North Carolina, Chapel Hill
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 20-0328