2024-518549-27-00招募中4 期
Efficacy of Reduced Gadolinium Dose in Contrast-Enhanced Breast MRI
Radboud universitair medisch centrum Stichting1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年2月20日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Qualitative Evaluation of image quality
研究概览
简要总结
To evaluate whether AI-enhanced low-dose gadolinium contrast-enhanced breast MRI achieves diagnostic image quality equivalent to standard-of-care-dose breast MRI
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Adult women ( > 18 years old) that are scheduled to undergo contrast-enhanced breast MRI
排除标准
- •Women under 18 years old
- •Individuals not scheduled for contrast-enhanced breast MRI
- •Pregnant or breastfeeding women
- •Individuals with contraindications to MRI (e.g., pacemakers, metal implants) and claustrophobia
- •Patients with renal insufficiency (eGFR < 30 ml/min/1.73m2)
- •Patients on hemodialysis or peritoneal dialysis
- •Patients with known allergic reactions to GBCAs
- •Male subjects
- •Women who cannot give informed consent
结局指标
主要结局
Qualitative Evaluation of image quality
Qualitative Evaluation of image quality
Quantitative Evaluation of image quality
Quantitative Evaluation of image quality
次要结局
- Diagnostic performance
研究者
Stichting Radboud University Medical Center
Scientific
Radboud universitair medisch centrum Stichting
研究点 (1)
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