Evaluation of Endometriosis With 18F-fluorofuranylnorprogesterone Positron Emission Tomography-Magnetic Resonance Imaging (PET / MRI)
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Sensitivity of 18F-fluorofuranylnorprogesterone (FFNP) PET/MR for evaluating endometriosis
研究概览
简要总结
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.
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 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
18F-fluorofuranylnorprogesterone PET / MRI
All enrolled subjects will receive the tracer and then have a PET/MRI scan.
干预措施: 18F-fluorofuranylnorprogesterone PET / MRI (Drug)
结局指标
主要结局
Sensitivity of 18F-fluorofuranylnorprogesterone (FFNP) PET/MR for evaluating endometriosis
时间窗: Upon completion of all study image data collection for all participants [approximately 1 year]
The sensitivity of FFNP PET /MR is defined as the ability of readers (radiologists) to correctly detect endometriosis in patients who have endometriosis.
Specificity of 18F-fluorofuranylnorprogesterone (FFNP) PET/MR for evaluating endometriosis
时间窗: Upon completion of all study image data collection for all participants [approximately 1 year]
The specificity is similarly defined as the ability of readers to exclude endometriosis in patients who do not have it.
次要结局
- Diagnostic accuracy of PET /MRI(Upon completion of all study image data collection for all participants [approximately 1 year])
- Correlation of uptake values (SUV-max) with Endometriosis Health Profile (EHP-30) scale controlling for covariates(Upon completion of all study image data collection for all participants [approximately 1 year])
- Correlation of uptake values (SUV-max) with pain level using a visual analog scale (VAS) controlling for covariates(Upon completion of all study image data collection for all participants [approximately 1 year])