Interstitial Assessment of Architectural Heterogeneity in Prostate Cancer Using a Fine Needle Photoacoustic Probe
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Demonstration of reliable measurements
研究概览
简要总结
In this project, we will integrate the Photoacoustic (PA) technology into a prostate biopsy procedure through a fine needle probe. The needle probe will be in the shape of a biopsy needle and compatible with the needle insertion mechanism in the transrectal ultrasound (TRUS) probe. When inserted into the prostate, the fine needle PA probe will assess the histological information in its surrounding tissue without any tissue extraction. The needle probe has been tested in prostate tissue samples and whole human prostates ex vivo.
详细描述
14AUG2024- enrollment was increased to 50 subjects
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •1) Planned prostate biopsy as part of routine clinical care
- •2) > 40 and <80 years old
排除标准
- •1) Known history of bleeding disorders or
- •2) Patients taking anticoagulants, no matter doses or washout time
- •3) Known allergy to silicone material
- •4) Unable to provide informed consent
- •5) Either the surgeon or the patient do not think the patient will not be able to complete all parts of the study, the patient will be excluded
- •6) Involved in other investigational studies.
结局指标
主要结局
Demonstration of reliable measurements
时间窗: day 1
The primary aim of this study is to demonstrate that our fine needle PA probe can acquire reliable measurements of prostate glands. This will be indicated by a signal-to-noise ratio of the measurements that is larger than one. We will calculate the signal to noise ratio of the signals as the peak-to-peak signal magnitude over the amplitude of the system background signal. The technical failure is that we will not be able to achieve measurements with signal-to-noise ratios larger than 1 in 10% of the measurements. We will have a futility analysis after first 5 patients are completed (thus 10 measurements). If of those 10 measurements, 2 have a SNR less 1, then the study will be stopped as it is unlikely to meet its 90% target.
次要结局
- Determining the ability to observe differences between benign and cancerous regions(day 1)