A Feasibility Study to Evaluate 18F-choline Cerenkov Luminescence Imaging for Measuring Margin Status in Radical Prostatectomy Specimens
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Margin status of prostatectomy specimen as determined by the LightPathTM Imaging System
研究概览
简要总结
This study will evaluate the feasibility of using intra-operative Cerenkov Luminescence Imaging (CLI) of prostatectomy specimens to determine tumour margin status. The samples will be imaged using the LightPathTM Imaging System which consists of a light-tight box containing an ultra-sensitive lens and radiation-shielded camera. This study will measure the correlation between margin status of the WLE specimen and the metastatic status of dissected lymph nodes as determined by the LightPathTM Imaging System and by histopathology. This is a pilot study to assess feasibility before proceeding to a pivotal study to evaluate the benefits of the LightPathTM system in clinical practice.
详细描述
This study is a prospective, single-centre feasibility study to evaluate the use of intra-operative Cerenkov Luminescence Imaging (CLI) of prostatectomy specimens to determine margin status.
Subjects will receive an intravenous injection of 370 Mega Becquerel (MBq) of 18F-choline prior to routine, elective radical prostatectomy. The surgery will be performed according to standard-of-care. The resected prostatectomy specimens will be imaged using the LightPathTM Imaging System, consisting of a light-tight box containing an ultra-sensitive lens and Electron Multiplying Charged-Coupled Device (EMCCD) camera.
This study will measure the agreement between margin status of the prostatectomy specimen as determined by CLI and by histopathology (reference method). This study will assess feasibility before proceeding to a pivotal study to evaluate the benefits of the LightPathTM Imaging System in clinical practice.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men ≥18 years of age diagnosed with high risk prostate cancer, defined as clinical stage ≥T2c, or PSA>20 ng/ml, or Gleason Score 8-
- •Patients undergoing radical prostatectomy
排除标准
- •Known hypersensitivity to 18F-choline
- •Patients currently taking colchicine
- •Prior therapy for prostate cancer (e.g. focal therapy)
结局指标
主要结局
Margin status of prostatectomy specimen as determined by the LightPathTM Imaging System
时间窗: Intra-operative
Use of the LightPathTM Imaging System will be examined in order to assess the feasibility of using CLI for determining margin status intraoperatively.
次要结局
- The agreement between margin status as determined by CLI and histopathology(Intra and immediate post-operative)