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临床试验/NCT03653702
NCT03653702尚未招募1 期

Radiation-Free Technique for Evaluating Renal Scarring (RAFTERS)

Boston Children's Hospital1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2027年7月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
尚未招募
入组人数
70
试验地点
1
主要终点
Performance of CEUS result and comparison to DMSA

研究概览

简要总结

In this research study the investigators want to study a safe, radiation-free technique known as contrast-enhanced ultrasound that may improve the ability to diagnose or evaluate renal scarring compared to regular ultrasound. This technique requires injection into a vein of a small amount of contrast material called Lumason. Contrast material is a type of dye that helps the investigators image the structures in the body more clearly. If this technique is successful, the need for DMSA studies may be avoided to diagnose or evaluate kidney scarring. DMSA is a more expensive test, causes radiation exposure, may require sedation and/or injection of contrast agents with the potential to cause allergic reactions.

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
6 Months 至 35 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • patients older than or equal to 6 months and less than or equal to 35 years old and scheduled for Boston Children's Hospital (BCH) DMSA scan to evaluate renal function and/or renal scarring

排除标准

  • patients with significant congenital renal anatomical abnormalities including horseshoe kidney, kidney malrotation, and multicystic dysplastic kidney (MCDK). Patients with severe cardio-pulmonary diseases will also be excluded.

研究组 & 干预措施

Contrast Enhanced Ultrasound

Experimental

Participants will undergo a contrast enhanced ultrasound (CEUS) using Lumason

干预措施: Lumason (Drug)

结局指标

主要结局

Performance of CEUS result and comparison to DMSA

时间窗: 3 months after final participant completes participation

DMSA will be used as gold standard to evaluate CEUS test performance. Sensitivity and specificity of CEUS renal scarring detection will be calculated accordingly. Bivariate and multivariate analyses will be completed to compare patient characteristics between those with good and poor CEUS performance to investigate if CEUS performs better in patients with specific covariates

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Richard Lee

Principal Investigator

Boston Children's Hospital

研究点 (1)

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