Evaluation of Endometriosis With 18F-fluoroestradiol PET / MRI
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Specificity of FES PET/MRI for Evaluating Endometriosis (Percentage of Negative Scans)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Institutionalized subject (prisoner or nursing home patient)
- •Known history of breast, ovarian or endometrial cancer.
- •Pregnant or breast-feeding women
研究组 & 干预措施
18F-fluoroestradiol PET / MRI
All enrolled subjects will receive the tracer and then have a PET/MRI scan.
干预措施: 18F-fluoroestradiol (Drug)
结局指标
主要结局
Specificity of FES PET/MRI for Evaluating Endometriosis (Percentage of Negative Scans)
时间窗: day of scan, up to 2 hours
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.
Sensitivity of FES PET/MRI for Evaluating Endometriosis (Percentage of Positive Scans)
时间窗: day of scan, up to 2 hours
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.
次要结局
- Correlation of the FES PET/MRI Specificity to Conventional MRI(day of scan, up to 2 hours)
- Mean Standard Uptake Values (SUV-max) for 18F-fluoroestradiol PET / MRI(day of scan, up to 2 hours)