ChiCTR2400088035Not yet recruitingEarly Phase 1
基于 VCUG 图像构建对 VUR 自动诊断和分级的 Deep-VCUG 模型研究
自筹3 sites in 1 countryStarted: January 1, 2024Last updated:
Trial Snapshot
- Phase
- Early Phase 1
- Status
- Not yet recruiting
- Sponsor
- Locations
- 3
- Primary Endpoint
- VUR 返流分类结果的曲线下面积
Study Overview
Brief Summary
本研究旨在开发一种深度学习模型,以提高 VUR 对 VCUG 评分的可靠性,并将其性能与临床医生的性能进行比较。
Study Design
- Study Type
- 诊断试验
- Primary Purpose
- 连续入组
- Masking
- N/a
Eligibility Criteria
- Ages
- 1 to 12 (—)
- Sex
- All
Inclusion Criteria
- •在多中心医院就诊并行 VCUG 检查的患儿,年龄 1-13 周岁,影像诊断为膀胱输尿管返流,VCUG 图像清晰,无严重金属伪影。
Exclusion Criteria
- •无法观察到完整输尿管、图像质量差、畸形过多(如泄殖腔畸形、异位输尿管和尿道下裂)、缺乏斜位片均被排除在外。
Outcomes
Primary Outcomes
VUR 返流分类结果的曲线下面积
VUR 返流分类结果的准确性
VUR 返流分类结果的灵敏度
VUR 返流分类结果的特异度
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (3)
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