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RecruitingNCT06944483

Same-day Radioembolization for Large HCC

Same-day Radioembolization for Large HCC (>5cm) With Y90 Resin Microspheres : Multicenter Prospective Registry Study

Sponsor

Seoul National University Hospital

Enrollment

138 participants

Start Date

Apr 25, 2025

Study Type

OBSERVATIONAL

Conditions

Hepatocellular Carcinoma (HCC)

Summary

In patients who has no sign suggesting high lung shunt fraction (TIPS, hepatic vein invasion, hepatic vein enhancement on arterial phase, dysmorphic intratumoral vessel), planning angiography, MAA scan, and radioembolization are performed in a single day with SIR-Spheres. This prospective registry will prove that the selection criteria is accurate and same-day radioembolization is feasible and safe.

Eligibility

Min Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a same-day treatment approach for large liver tumors (hepatocellular carcinoma, or HCC) using radioembolization — a procedure where tiny radioactive beads are injected directly into the blood vessels feeding the tumor to destroy it from the inside. **You may be eligible if...** - You have been diagnosed with liver cancer (hepatocellular carcinoma) - Your tumor is 5 cm or larger - Your liver function is relatively preserved (Child-Pugh class A) - You are in reasonably good physical health (ECOG 0 or 1) - Your blood counts, liver enzymes, and clotting factors are within acceptable ranges **You may NOT be eligible if...** - Your liver function is significantly impaired (Child-Pugh B or C) - Your blood counts or clotting levels are outside safe limits - You have certain blood vessel characteristics that make the procedure unsafe - Your overall health would not support undergoing the procedure 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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Interventions

PROCEDUREsame-day radioembolization

On the day of the procedure, angiography is performed, followed by cone-beam CT of the hepatic artery. After injecting 99mTc-MAA into the hepatic artery, the patient is transferred to the nuclear medicine department for a lung shunt scan and lung SPECT/CT. The lung shunt fraction is determined using the planar images. Using diagnostic CT/MRI and 99mTc-MAA images, the treatment dose is calculated with the multi-compartment MIRD method. The acceptable range for tumor absorbed dose is ≥100 Gy, and the lung dose must be ≤15 Gy. The tumor absorbed dose must be at least 100 Gy and should ideally be within the range of 300 to 600 Gy. There is no upper limit for the tumor absorbed dose.

Locations(4)

National Cancer Center

Goyang, South Korea

Samsung Medical Center

Seoul, South Korea

Seoul National University Hospital

Seoul, South Korea

Severance hospital

Seoul, South Korea

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NCT06944483

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