Use of Fibroblast Activation Protein Inhibitor (FAPI) PET-CT Before Surgery in Patient with Endometriosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Diagnostic Accuracy of FAPI PET-CT in Endometriosis Detection
研究概览
简要总结
Patients with suspected endometriosis scheduled for surgery will be identified. They will be asked to participate in a study evaluating the feasibility of FAPI PET-CT in diagnosing endometriosis. The results will be compared with surgical findings, pathology, and other imaging techniques if available (i.e., MRI, US).
详细描述
This study investigates FAPI PET-CT imaging in endometriosis diagnosis using a standardized protocol. Participants will undergo two imaging sessions after a single FAPI injection:
First Session:
Initial scan at 10 minutes post-injection Follow-up scan at 30 minutes
Second Session:
Additional scans at 60 and 80 minutes post-injection
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
盲法说明
Open label study. The surgeon operates based on PET-CT findings, and the pathologist examines specimens from lesions detected on PET-CT
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female participants aged 18-45 years
- •Clinical suspicion of endometriosis based on symptoms
- •Scheduled for diagnostic/therapeutic laparoscopic surgery
- •Ability to understand and provide written informed consent
- •Completed and signed Radiation Exposure Documentation Form
排除标准
- •Pregnant women or women who are breastfeeding
- •History of pelvic radiation therapy
- •Known active malignancy
- •Exposure to ionizing radiation for medical purposes within 12 months prior to enrollment
结局指标
主要结局
Diagnostic Accuracy of FAPI PET-CT in Endometriosis Detection
时间窗: Within 1 month post-surgery
Assessment of FAPI PET-CT diagnostic performance through calculation of sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV). Surgical findings with histological confirmation will serve as the reference standard for evaluation.
次要结局
- Comparison of FAPI PET-CT with Conventional Imaging(Within 1 month post-surgery)
研究者
Israel Sandler
MD
Ziv Medical Center