New scout dose method could make liver cancer radiation safer for lungs
NCT ID NCT07476651
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new method to check if a liver cancer treatment called radioembolization is safe for the lungs. Currently, doctors use a test particle (MAA) to estimate lung radiation risk, but it may not be perfectly accurate. The new method uses a small 'scout dose' of the actual treatment beads (Y-90 microspheres) and a PET/CT scan to get a more precise measurement. The study will enroll 30 adults with liver tumors to compare the two approaches.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Yttrium-90 resin microspheres (SIR-Spheres)
- What this could lead to
- If successful, this could make radioembolization safer by more accurately measuring how much radiation reaches the lungs, and provide a reliable alternative when the current test is unavailable.
- What could go wrong
- This is a small early study with only 30 participants, so results may not apply to everyone. The extra procedure adds time and discomfort, and the scout dose itself carries a small radiation risk.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2026
- Expected to finish
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Dec 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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19 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Seoul National University Hospital
RECRUITINGSeoul, 03080, South Korea
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