ProstateAI - A Prospective Paired Validating Cohort Study to Evaluate an MRI-based Optimized Prostate Cancer Diagnostic Pathway Powered by Artificial Intelligence
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 368
- 试验地点
- 1
- 主要终点
- Prostate Cancer detection rate of ISUP grade group ≥2
研究概览
简要总结
It is a prospective paired-cohort study for diagnostic test evaluation. The study aim to determine the accuracy of AI review and investigate whether AI review could detect MRI visible significant cancer as effective as radiologist review. MRI image of about 368 men recommended for biopsy will be reviewed by an AI model and an experienced radiologist, respectively. AI review (index) and radiologist review (standard) will be blinded to each other, while biopsy urologists will be well-informed of the findings of both AI review and radiologist review and make personalized biopsy plan by combining both findings. The pathological results of MRI-ultrasound fusion biopsy (reference) will serve as the gold standard to assess the diagnostic accuracy.
详细描述
ProstateAI is a prospective paired-cohort study for diagnostic test evaluation. ProstateAI will determine the accuracy of AI review and investigate whether AI review could detect MRI visible significant cancer as effective as radiologist review. MRI image of about 368 men recommended for biopsy will be reviewed by an AI model and an experienced radiologist, respectively. AI review (index) and radiologist review (standard) will be blinded to each other, while biopsy urologists will be well-informed of the findings of both AI review and radiologist review and make personalized biopsy plan by combining both findings. The pathological results of MRI-ultrasound fusion biopsy (reference) will serve as the gold standard to assess the diagnostic accuracy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Single (Care Provider)
盲法说明
AI review (index) and radiologist review (standard) will be blinded to each other, while biopsy urologists will be well-informed of the findings of both AI review and radiologist review and make personalized biopsy plan by combining both findings.
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
- •Patients recommended for prostate biopsy for diagnosis or re-assessment.
- •Men at least 18 years or over
- •Patients with prostate MRI image eligible for radiologist review and AI review.
- •Patient Informed Consent is signed.
排除标准
- •Patient contraindicated to prostate biopsy
- •Patient failed to complete the biopsy procedure
研究组 & 干预措施
AI review (index)
self-paired design, AI review (index)
干预措施: AI modal (Diagnostic Test)
Radiologist review (Standard)
self-paired design, radiologist review (standard)
干预措施: Standard review (Diagnostic Test)
结局指标
主要结局
Prostate Cancer detection rate of ISUP grade group ≥2
时间窗: Through study completion, an average of 1 year
Assessed by AI review, Radiologist review, and Biopsy (Targeted).
次要结局
- Diagnosis of any grade of prostate cancer(Through study completion, an average of 1 year)
研究者
CHIU Ka Fung Peter
Associate Professor
Chinese University of Hong Kong