Feasibility of Gadolinium Contrast Reduced Brain MRI: the Potential of Deep Learning
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 入组人数
- 101
- 主要终点
- Vessel conspicuity
研究概览
简要总结
MRI scans were performed using 3 different 1.5T scanners with an eight-channel head coils. Following a 3D pre-contrast T1w scan, a low-dose contrast-enhanced 3D T1w scan was obtained using 20% (0.02 mmol/kg) of the standard dosage of gadoterate meglumine.
The subjects were immediately administered the remaining 80% (0.08 mmol/kg) of the contrast agent to reach the standard dose of 0.1 mmol/kg, which served as a training ground truth for further quantitative assessment. All three acquisitions were performed during a single imaging session, with no additional gadolinium dose administered above the standard protocol.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Clinical indications for imaging with a contrast-enhanced 3D-T1w MRI sequence including tumor suspicion, postoperative tumor follow-up, multiple sclerosis, routine brain imaging, etc.,
- •no plan for dynamic contrast administration or deviation from the standard dose of 0.1 mmol/kg body weight (e.g., sella imaging, magnetic resonance angiography),
- •no clinical contraindications to imaging prolongation (i.e., emergency, poor patient condition).
排除标准
- •prominent image artifacts,
- •incomplete study sequences (e.g., early termination)
- •errors related to contrast agent administration.
结局指标
主要结局
Vessel conspicuity
时间窗: 1 Day After MRI session
(0) no normal vessels observed, (1) significant decrease in conspicuity with potential impact on diagnosis, (2) mild decrease in conspicuity with unlikely impact on diagnosis, (3) normal conspicuity, (4) mild increase in conspicuity with unlikely impact on diagnosis, and (5) significant increase in conspicuity with potential impact on diagnosis.
Image quality
时间窗: 1 Day After MRI session
Image quality using a 5-point Likert scale covering 1 (none), 2 (poor), 3 (moderate), 4 (good), and 5(excellent) ratings
次要结局
- Enhancement pattern(1 Day After MRI session)