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Scout Dose of Resin Microspheres

RecruitingNAAges 19 Years - anyAllSeoul National University Hospital
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In plain words

What the trial is, and whether it could suit you

This study looks at a liver cancer treatment called radioembolization and tests a new, possibly more accurate way to check if the treatment is safe for a patient's lungs. Radioembolization is a procedure where tiny beads containing a radioactive substance (yttrium-90) are injected into the arteries that feed a liver tumor. These beads lodge mainly in the tumor and deliver radiation directly to it, while sparing most of the normal liver. However, some of these beads can bypass the liver circulation and travel to the lungs. If too many reach the lungs, they can cause serious radiation damage called radiation pneumonitis. To avoid this, doctors currently perform a "test run" before the real treatment. They inject a different particle called MAA into the liver artery and then do nuclear medicine scans to see how much of it goes to the lungs versus the liver. This percentage is called the l

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * Adults aged 19 years or older * Hepatocellular carcinoma diagnosed radiologically according to the American Association for the Study of Liver Disease diagnostic criteria or diagnosed histologically, histologically diagnosed intrahepatic cholangiocarcinoma, or liver metastases * Volume of liver not included in the treatment field is at least 30% of the total non-tumorous liver volume * Child-Pugh class A * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 ⑥ Patients with lung shunt fraction ≤20% on MAA scan (planar image) ⑦ Patients with no major organ abnormalities on blood tests performed within 2 months before treatment: • A. Leukocytes ≥ 1,000/µL and ≤ 20,000/µL • B. Hemoglobin ≥ 6.0 g/dL (transfusion allowed to meet this criterion) • C. Total bilirubin ≤ 2.0 mg/dL • D. Platelet ≥ 40,000/µL • E. International normalized ratio (INR) ≤ 2.0 for patients not taking anticoagulants * F. Aspartate transaminase (AST) ≤ 800 IU/L (i.e., ≤ 20X upper normal limit) * G. Alanine transaminase (ALT) ≤ 800 IU/L (i.e., ≤ 20X upper normal limit) * H. Creatinine ≤ 2.5 mg/dL (no restriction for dialysis patients) ⑧ Patients with life expectancy of at least 3 months ⑨ For women of childbearing potential, those with negative serum pregnancy test ⑩ Patients who fully understand the content of the prospective observational study and provide written informed consent Exclusion Criteria: 1. Patients with biliary-enteric anastomosis or biliary stent 2. Cases where the operator judges that even mild radiation pneumonitis could be fatal due to findings of emphysema or interstitial lung disease on chest CT 3. Patients with a history of severe hypersensitivity reaction to iodinated contrast agents 4. Patients with contraindications to angiography or catheter manipulation 5. Patients with lung shunt fraction \>20% on MAA scan (planar image)
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What it tests

  • scout dose
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Where

1 site
Seoul National University Hospital
Seoul, South Korea
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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