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临床试验/NCT06441292
NCT06441292尚未招募不适用

Study on Prostate Targeted Biopsy Precision Navigation Method Based on Multi-Modal Image Fusion Deep Learning Using Multi-Parameter Ultrasound and MRI

Shanghai East Hospital1 个研究点 分布在 1 个国家目标入组 602 人开始时间: 2024年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
602
试验地点
1
主要终点
The detection rate of clinically significant prostate cancer by targeted biopsy alone

研究概览

简要总结

This study is a prospective randomized controlled clinical trial aimed at comparing the detection rates of clinically significant prostate cancer between conventional biopsy methods and AI-assisted biopsy methods in patients undergoing initial prostate biopsy who meet the indications for prostate biopsy.

详细描述

This study is a prospective randomized controlled clinical trial designed to investigate the efficacy of AI-assisted biopsy methods compared to conventional biopsy methods in detecting clinically significant prostate cancer. The target population includes patients undergoing their initial prostate biopsy who meet established indications for prostate biopsy.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • PSA > 4 ng/ml and/or abnormal DRE
  • Sign the informed consent

排除标准

  • Have acute or chronic prostatitis
  • Contraindications to prostate biopsy
  • Contraindications to MRI
  • Other reasons that not suitable for this trial

结局指标

主要结局

The detection rate of clinically significant prostate cancer by targeted biopsy alone

时间窗: 2-3 weeks post-biopsy

The proportion of men with a Gleason score ≥3+4 in pathological assessment for targeted biopsy samples

次要结局

  • The detection rate of clinically significant prostate cancer by targeted biopsy combined with template biopsy(2-3 weeks post-biopsy)
  • The detection rate of any prostate cancer by targeted biopsy alone(2-3 weeks post-biopsy)
  • The detection rate of any prostate cancer by targeted biopsy combined with template biopsy(2-3 weeks post-biopsy)

研究者

发起方
Shanghai East Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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