Investigation of an Intelligent Centre-adaptive Multi-modal Fusion Framework (Cad- MMFF) to Overcome Unnecessary Prostate Biopsies and Optimize MRI Utilization: a Hybrid Retrospective-prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Proportion of MRI safely saved of using the Centre-adaptive multi-modal fusion framework (Cad-MMFF)
研究概览
简要总结
This study aims to investigate a novel Centre-Adaptive Multi-Modal Fusion Framework (Cad-MMFF) that integrates clinical, ultrasound, and MRI data to improve the detection of clinically significant prostate cancer (csPCa), reduce unnecessary biopsies, and optimize MRI utilization.
详细描述
Approximately 400 Chinese men aged 50 years or above with suspected prostate cancer will be included.The study consists of retrospective model development and prospective model optimization and validation. Two AI models will be developed: a Clinical-US model using clinical and ultrasound data, and a Clinical-US-MRI model incorporating MRI information. The optimized models will subsequently be validated in an independent cohort.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Ethnically Chinese men aged ≥ 50
- •Suspicion of PCa [elevated PSA (>4-ng/ml) or abnormal DRE/PHI] and indicated for prostate biopsy
- •Obtained clinical consent (for prospectively enrolled patients only)
排除标准
- •Prior biopsy/treatments for PCa
- •History of genitourinary cancer
- •Poor image quality
- •Incomplete imaging scans/clinical data/pathological results
结局指标
主要结局
Proportion of MRI safely saved of using the Centre-adaptive multi-modal fusion framework (Cad-MMFF)
时间窗: Through study completion, an average of 1 year
Area under Receiver-Operating-Curve of using the Centre-adaptive multi-modal fusion framework (Cad-MMFF)
时间窗: Through study completion, an average of 1 year
The number of unnecessary biopsy rate decreased of using the Centre-adaptive multi-modal fusion framework (Cad-MMFF)
时间窗: Through study completion, an average of 1 year
Net-Benefit of using the Centre-adaptive multi-modal fusion framework (Cad-MMFF)
时间窗: Through study completion, an average of 1 year
By Decision Curve analysis
Missed rate of clinically significant prostate cancer of using the Centre-adaptive multi-modal fusion framework (Cad-MMFF)
时间窗: Through study completion, an average of 1 year
Detection rate of indolent prostate cancer of using the Centre-adaptive multi-modal fusion framework (Cad-MMFF)
时间窗: Through study completion, an average of 1 year
次要结局
未报告次要终点
研究者
NG Chi Fai
Professor
Chinese University of Hong Kong