Indocyanine Green for Biliary Atresia

This trial tests a new method to diagnose biliary atresia, a rare liver disease in infants that blocks bile ducts. Researchers use a fluorescent dye called Indocyanine Green (ICG) to determine if it can help identify this condition. If the dye does not appear in the stool, it may indicate a blocked bile duct. Infants younger than 3 months with liver issues, particularly those undergoing a HIDA scan for biliary atresia, may be suitable for this trial.

As a Phase 1, Phase 2 trial, this research aims to understand how the treatment works in people and measure its effectiveness in an initial, smaller group. Participants have the opportunity to contribute to groundbreaking diagnostic advancements.

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Studies have shown that Indocyanine Green (ICG) is generally safe and well-tolerated in infants, particularly for conditions like biliary atresia. Research indicates that surgeons often use ICG in liver-related procedures, and it has a strong safety record with minimal harm. In pediatric surgeries, ICG enhances visibility of affected areas without causing damage. One study also confirmed the safety of ICG in infants with liver conditions, providing reassurance for those considering joining a trial.¹²³⁴⁵

Indocyanine Green (ICG) is unique because it offers a new way to diagnose and potentially manage biliary atresia through its fluorescent properties. Unlike traditional treatments that focus on surgical intervention, ICG can help visualize bile ducts and liver function in real-time, providing immediate insights into the condition's severity. This new mechanism of action allows for more precise treatment planning and monitoring, which could lead to better outcomes for infants with biliary atresia. Researchers are excited about ICG because it not only aids in accurate diagnosis but also holds the potential to personalize treatment strategies.

Research has shown that Indocyanine Green (ICG) effectively checks if bile ducts are open. One study found that ICG was 97% accurate in confirming proper bile flow in patients without bile duct blockages. In this trial, all infants will receive an ICG injection. A lack of glow in the stool after the injection may indicate blocked bile ducts, suggesting a condition called biliary atresia. ICG is taken up by the liver and then released into the bile, allowing doctors to assess bile duct function. This makes it a promising tool for diagnosing biliary atresia in infants.²⁴⁶⁷⁸