Optimization of PCaVision: A Prospective Study for CAD-based Detection of Clinically Significant Prostate Cancer Using mpUS and Contrast Agents
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 212
- 试验地点
- 1
- 主要终点
- Sensitivity and Specificity of PCaVision Algorithm (Sonovue and Optison) Compared to Histopathology
研究概览
简要总结
This prospective clinical study aims to retrain and validate the PCaVision AI algorithm for the detection and localization of clinically significant prostate cancer (csPCa) using multiparametric ultrasound (mpUS) with two different ultrasound contrast agents: Sonovue and Optison. Data will be collected using a commercial version of the LOGIQ E10 ultrasound machine, with full histopathological correlation in patients undergoing radical prostatectomy.
详细描述
The PCaVision CAD system was initially developed using Sonovue contrast and a research-only ultrasound machine (LOGIQ E10 R3). In this study, the algorithm will be retrained using data acquired from the LOGIQ E10 R4, a commercially available system, and using both Sonovue and Optison as contrast agents. The goal is to enhance generalizability and enable broader clinical adoption. The study includes two cohorts: patients scheduled for radical prostatectomy (for training and voxel-level validation) and patients with a negative prostate MRI (for patient-level specificity evaluation). All participants will undergo 3D transrectal mpUS with both contrast agents in a single session. Full prostate histology from RP specimens will serve as the reference standard.
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
- •Male ≥18 years
- •Cohort 1: Histologically confirmed prostate cancer scheduled for radical prostatectomy
- •Cohort 2: Negative multiparametric prostate MRI (PI-RADS ≤ 2)
排除标准
- •Severe pulmonary hypertension
- •Cardiac right-to-left shunt
- •Known allergy to Sonovue or Optison
- •Contraindication for ultrasound contrast agents
结局指标
主要结局
Sensitivity and Specificity of PCaVision Algorithm (Sonovue and Optison) Compared to Histopathology
时间窗: From baseline imaging to histopathology report (typically within 2-4 weeks post-surgery)
Sensitivity and specificity of the PCaVision algorithm in detecting and localizing clinically significant prostate cancer (csPCa, Gleason Grade Group ≥2) at the voxel level, based on 3D multiparametric ultrasound (mpUS) images using Sonovue and Optison, validated against full prostate histology after radical prostatectomy.
次要结局
- Specificity of PCaVision in MRI-Negative Cohort(From baseline imaging to completion of image processing and analysis (within 2 weeks of scan))
- Diagnostic Performance Comparison Between Sonovue and Optison(Imaging and analysis completed within 4 weeks post-surgery)
研究者
Harrie P. Beerlage
Prof. Dr. H.P. Beerlage
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)