In-vivo Focal Prostate Imaging With Confocal Laser Endomicroscopy and Optical Coherence Tomography
试验速览
- 阶段
- 不适用
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Visual image criteria for CLE and quantitative parameters (attenuation coefficient and residue) of OCT for the characterization of the prostate tissue
研究概览
简要总结
The current limitations in prostate cancer diagnostics lead to over- and undertreatment for a significant fraction of patients. Confocal Laser Endomicroscopy (CLE) and Optical Coherence Tomography (OCT) are focal imaging modalities with potential for in-vivo prostate imaging. The investigators anticipate that integrating focal imaging with MRI/TRUS fusion will further improve prostate cancer detection and provides a real-time histopathological threedimensional representation of the tumor lesions.
This is an investigator-initiated, prospective in-vivo safety and feasibility study with transperineal template mapping biopsies (TTMB) and two focal imaging methods, CLE and OCT, in prostate tissue.
详细描述
Study design:
This is an investigator-initiated, prospective in-vivo safety and feasibility study with two procedures.
Procedure 1 (AMC):
Patients that are indicated for transperineal template mapping biopsies (TTMB) are included for procedure 1 and will receive transperineal CLE or OCT measurements prior to TTMB. Procedure 1 is to test the technical feasibility and safety of in-vivo focal imaging with CLE and OCT. Only if transperineal CLE or OCT measurements are possible, the investigators proceed with procedure 2.
For procedure 1: 4 patients that are scheduled for TTMB; 2 patients for CLE and 2 patients for OCT.
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
- Male
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Optical imaging
All consenting patients will undergo Confocal Laser Endomicroscopy or Optical Coherence Tomography imaging prior to biopsy or surgery.
干预措施: Confocal Laser Endomicroscopy (Device)
结局指标
主要结局
Visual image criteria for CLE and quantitative parameters (attenuation coefficient and residue) of OCT for the characterization of the prostate tissue
时间窗: 2 years
* Describing visual characteristics on CLE imaging * Attenuation coefficient on OCT imaging calculated with our in-house build software * Residue of the OCT imaging calculated with our in-house build software
次要结局
- Technical feasibility of CLE and OCT imaging in the prostate by a transperineal approach(2 years)
- Safety of CLE and OCT imaging in the prostate(2 years)
研究者
Dr. T.M. de Reijke
Theo M. de Reijke
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)