Scout-dose check using resin microspheres before yttrium-90 treatment for liver tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Before yttrium-90 radioembolization, doctors typically use 99mTc‑MAA scans to estimate how many particles might reach the lungs, but MAA can mispredict actual particle distribution. This interventional protocol gives a small 'scout' dose of the therapeutic resin microspheres into the hepatic artery and images where they go to measure lung shunt directly. Eligible participants are adults with HCC, intrahepatic cholangiocarcinoma, or liver metastases who meet liver-function and laboratory criteria and have an ECOG performance status ≤1. The trial collects imaging and safety data to see if the scout dose improves decision-making and reduces the risk of lung radiation injury before full-dose treatment.

Why it matters

Who can join: the full rules

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)

Where it's running

• Seoul National University Hospital
  Seoul, South Korea Recruiting

Study contacts

• Study coordinator: Hyo-Cheol Kim, MD
• Email: radioembolization@snu.ac.kr
• Phone: 82-10-5136-5205

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.