RecruitingNCT07043387

Streamlining Radioembolization for CCC and Metastatic Liver Cancer

Streamlining Radioembolization for Cholangiocarcinoma or Metastatic Liver Cancer ≤ 7 cm : Multicenter Prospective Registry Study


Sponsor

Seoul National University Hospital

Enrollment

60 participants

Start Date

Jun 22, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

TARE uses radioactive microspheres (20-60 μm), which are trapped in tumors due to abnormal vasculature, while normal liver sinusoids (≤15 μm) prevent their passage. However, some microspheres may drain into hepatic veins and reach the lungs, risking radiation pneumonitis. Pre-procedural evaluation with angiography and nuclear imaging (MAA scan with SPECT/CT) is required to calculate lung shunt fraction (LSF). TARE is contraindicated if LSF \>20%, and may be used with caution if LSF is 10-20%. Findings associated with high LSF include large tumors, hepatic vein invasion, TIPS, and dysmorphic intratumoral vessels. In contrast, small or medium sized (\<7 cm) cholangiocarcinoma or metastatic liver cancers without hepatic vein invasion or dysmorphic vessels show consistently low LSF (\<5%). Over 10 years at SNUH, no cases of radiation pneumonitis have been observed in such patients. Therefore, "streamlining TARE" omits pre-procedural nuclear imaging for this group to reduce procedural delays, reserving nuclear imaging for patients who need it most. SIR-Spheres (SIRTEX) facilitate single-session TARE as they are provided in a bulk vial, unlike TheraSphere which requires advance preparation based on dosimetry. Protocol Overview : Procedure: Same-day angiography, cone-beam CT, and TARE using SIR-Spheres. Dosimetry: Lung shunt fraction is assumed as 5%, estimated lung dose is capped at 10 Gy. Tumor dose goal: 80\~400 Gy (around 250Gy)(single-compartment MIRD), or 300 \~ 1000 Gy (multi-compartment MIRD). minimal tumor dose by partition dosimetry : 100Gy Software: Simplicit90Y for planning, Y90 PET/CT the next day for post-treatment dosimetry. Follow-up: 1 year; additional treatments follow institutional guidelines. This streamlined approach maximizes efficiency while maintaining safety in selected patients.


Eligibility

Min Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This study is streamlining a liver cancer treatment called radioembolization, where tiny radioactive beads are injected into the blood vessels feeding a liver tumor to destroy it from within. The study is testing a simplified, faster version of the procedure for patients with liver cancer (including bile duct cancer) or cancer that has spread to the liver from elsewhere. **You may be eligible if...** - You are 19 or older - You have metastatic liver cancer or cholangiocarcinoma (bile duct cancer) - Your largest tumor is 7 cm or smaller, and you have no more than 5 tumors - Your remaining healthy liver volume is adequate (at least 30%) - Your liver function is good (Child-Pugh class A) - You are in reasonably good physical condition (ECOG ≤1) - Your blood counts meet the required levels **You may NOT be eligible if...** - You have more than 5 liver tumors or tumors larger than 7 cm - Your remaining healthy liver is not large enough - Your liver function is significantly impaired - You have major organ dysfunction Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(4)

National Cancer Center

Goyang-si, South Korea

Samsung Medical Center

Seoul, South Korea

Seoul National University Hospital

Seoul, South Korea

Severance hospital

Seoul, South Korea

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NCT07043387


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