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临床试验/NCT07513038
NCT07513038招募中1 期

Use of Indocyanine Green (ICG) for the Diagnosis of Biliary Atresia

Boston Children's Hospital1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年8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
招募中
入组人数
20
试验地点
1
主要终点
Indocyanine green (ICG) fluorescence in stool

研究概览

简要总结

Biliary atresia is a rare, progressive liver disease that only affects infants. It leads to complete obstruction and scarring of the bile duct. Current non-invasive diagnostic tests have limited sensitivity.

Indocyanine Green (ICG) is a non-radioactive, fluorescent compound with several clinical applications including angiography for ophthalmologic testing, visualization during surgery, and measurement of liver function. After excitation with near infrared light (750-810 nm), ICG emits near infrared light at 850 nm, which can be detected by a special camera. ICG is taken up by the liver exclusively and excreted in the bile, where it is removed from the body in the stool. The hypothesis is that after injection of ICG, participants with biliary atresia will not have any fluorescence detected in the stool. Investigators aim to use ICG as a functional test of bile duct patency in participants with cholestasis being evaluated for biliary atresia.

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
0 Days 至 3 Months(Child)
性别
All
接受健康志愿者

入选标准

  • age <3 months viable infants
  • cholestasis (defined as direct bilirubin >1)
  • undergoing diagnostic HIDA scan to evaluate for biliary atresia

排除标准

  • kidney disease (eGFR <60 mL/min/1.73m2)
  • grossly bloody stools
  • history of bowel surgery or disease
  • history of allergic reaction to ICG, iodine, or shellfish
  • unable to provide informed consent

研究组 & 干预措施

Indocyanine Green (ICG)

Experimental

All infants enrolled in this study will receive an injection of ICG

干预措施: Indocyanine Green (ICG) (Drug)

结局指标

主要结局

Indocyanine green (ICG) fluorescence in stool

时间窗: 24 hours after injection

We will assess if there is presence or absence of ICG fluorescence in the stool 24 hours after injection. This will be done using fluorescent imaging (Stryker) and result confirmed by two study staff.

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

Andrew Wehrman

Primary Investigator

Boston Children's Hospital

研究点 (1)

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