Streamlined radioembolization for cholangiocarcinoma and metastatic liver cancer
Streamlining Radioembolization for Cholangiocarcinoma or Metastatic Liver Cancer ≤ 7 cm : Multicenter Prospective Registry Study
Seoul National University Hospital · NCT07043387
This study tests whether skipping the pre-procedure nuclear lung scan is safe and speeds up treatment for adults with small (≤7 cm), limited-number metastatic liver tumors or intrahepatic cholangiocarcinoma.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Seoul National University Hospital (other) |
| Drugs / interventions | radiation |
| Locations | 4 sites (Goyang-si and 3 other locations) |
| Trial ID | NCT07043387 on ClinicalTrials.gov |
What this trial studies
This is an observational protocol that selects patients judged to have low risk of lung shunting based on tumor size, lesion number, absence of hepatic vein invasion or dysmorphic intratumoral vessels, good liver function (Child-Pugh A), and ECOG performance 0–1. Standard transarterial radioembolization (TARE) normally requires angiography plus a macroaggregated albumin (MAA) nuclear scan to measure lung shunt fraction (LSF); this program documents outcomes when the nuclear scan is omitted for low-risk patients. The rationale is that small or medium tumors (<7 cm) without specific high-risk features consistently show very low LSF (<5%) in prior institutional experience, so omitting the scan could reduce delays and resource use. Patients are enrolled and managed at participating Korean tertiary centers with follow-up to capture safety outcomes such as radiation pneumonitis and liver toxicity.
Who should consider this trial
Good fit: Adults (≥19 years) with intrahepatic cholangiocarcinoma or metastatic liver cancer whose largest tumor is ≤7 cm, with 5 or fewer lesions, future liver remnant >30%, Child-Pugh A, ECOG ≤1, no major organ dysfunction, and no dysmorphic intratumoral vessels >3 mm are ideal candidates.
Not a fit: Patients with large tumors, hepatic vein invasion, TIPS, dysmorphic intratumoral vessels, high expected lung shunt, or poorer liver function/performance status are unlikely to benefit from omitting pre-procedure nuclear imaging.
Why it matters
Potential benefit: If successful, this approach could shorten time to treatment, lower testing burdens and costs, and maintain safety for carefully selected patients.
How similar studies have performed: Previous institutional and published data show low lung shunt fractions and no radiation pneumonitis in selected low-risk patients, but formally omitting the nuclear scan is a relatively novel, pragmatic approach with limited multicenter validation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
* Adult aged 19 and over
* metastatic liver cancer or cholangiocarcinoma
* the diameter of the largest tumor ≤ 7cm, tumor number 5 or less
* FLR volume \> 30% of total non-tumorous liver volume
* Dysmorphic intratumoral vessel : absent, if present, 3mm or thinner ⑥ Child-Pugh class A
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 ⑧ No major organ dysfunction according to blood test performed within two months of study enrollment 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 (If patients is undergoing hemodialysis, no limit of creatinine) ⑨ Patients with a life expectancy of more than 3 months ⑩ For women of childbearing age, a negative serum pregnancy test. ⑪ Patients who have adequately understood the clinical trial and consented in writing
Exclusion Criteria:
* hepatic vein invasion on dynamic computed tomography (CT) or magnetic resonance imaging (MRI)
* Hepatic vein enhancement on arterial phase CT/MRI
* dysmorphic intratumoral vessel \> 3mm on arterial phase CT/MRI
* TIPS is present
* Lobar portal vein enhancement on arterial phase CT/MRI due to AP shunt
* main portal vein tumor thrombosis
* Cases where the operator judges that the occurrence of even mild radiation pneumonitis could be fatal, based on marked emphysema or interstitial lung disease findings on chest CT
* biliary stent or bilioenteric anastomosis
* History of severe allergy of intolerance to contrast agents
* Contraindication to angiography or selective visceral catheterization
Where this trial is running
Goyang-si and 3 other locations
- National Cancer Center — Goyang-si, South Korea (NOT_YET_RECRUITING)
- Samsung Medical Center — Seoul, South Korea (NOT_YET_RECRUITING)
- Seoul National University Hospital — Seoul, South Korea (RECRUITING)
- Severance hospital — Seoul, South Korea (NOT_YET_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.
Conditions: Metastatic Colorectal Carcinoma, Metastatic Liver Cancer, Cholangiocarcinoma