Scout-dose check using resin microspheres before yttrium-90 treatment for liver tumors
Lung Shunt Fraction Measurement With Scout Dose of Resin Yttrium-90 Microspheres for Radioembolization (LASER)
This test tries a small 'scout' dose of the same resin microspheres used in yttrium-90 treatment to better measure lung shunt in adults with liver cancer or liver metastases.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Seoul National University Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Seoul) |
| Trial ID | NCT07476651 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults aged 19 or older with HCC, intrahepatic cholangiocarcinoma, or liver metastases who have Child‑Pugh A liver function, ECOG 0–1, adequate blood counts, and a lung shunt fraction ≤20% on MAA planar imaging are the intended participants.
Not a fit: Patients with worse liver function (Child‑Pugh B/C), ECOG >1, lung shunt >20%, or significant abnormal blood tests are unlikely to be eligible or to benefit from this approach.
Why it matters
Potential benefit: If successful, this approach could give a more accurate lung shunt measurement so safer patients proceed to treatment and fewer patients suffer lung radiation damage.
How similar studies have performed: Using the actual therapeutic microspheres as a scout dose is a relatively new approach with limited published evidence compared with standard 99mTc‑MAA scanning.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Seoul
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.