跳至主要内容
临床试验/2024-518549-27-00
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

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

发起方
Radboud universitair medisch centrum Stichting
申办方类型
Hospital/Clinic/Other health care facility
责任方
Principal Investigator
主要研究者

Stichting Radboud University Medical Center

Scientific

Radboud universitair medisch centrum Stichting

研究点 (1)

Loading locations...

相似试验