Streamlining Radioembolization for CCC and Metastatic Liver Cancer

Recruiting now

Conditions studied: Metastatic Colorectal Carcinoma (mCRC), Metastatic Liver Cancer, Cholangiocarcinoma

In brief

TARE uses radioactive microspheres (20-60 μm), which are trapped in tumors due to abnormal vasculature, while normal liver sinusoids (≤15 μm) prevent their passage. However, some microspheres may drain into hepatic veins and reach the lungs, risking radiation pneumonitis. Pre-procedural evaluation with angiography and nuclear imaging (MAA scan with SPECT/CT) is required to calculate lung shunt fraction (LSF). TARE is contraindicated if LSF \>20%, and may be used with caution if LSF is 10-20%. Findings associated with high LSF include large tumors, hepatic vein invasion, TIPS, and dysmorphic intratumoral vessels. In contrast, small or medium sized (\<7 cm) cholangiocarcinoma or metastatic liver cancers without hepatic vein invasion or dysmorphic vessels show consistently low LSF (\<5%). Over 10 years at SNUH, no cases of radiation pneumonitis have been observed in such patients. Therefore, "streamlining TARE" omits pre-procedural nuclear imaging for this group to reduce procedural delays, reserving nuclear imaging for patients who need it most. SIR-Spheres (SIRTEX) facilitate single-session TARE as they are provided in a bulk vial, unlike TheraSphere which requires advance preparation based on dosimetry. Protocol Overview : Procedure: Same-day angiography, cone-beam CT, and TARE using SIR-Spheres. Dosimetry: Lung shunt fraction is assumed as 5%, estimated lung dose is capped at 10 Gy. Tumor dose goal: 80\~400 Gy (around 250Gy)(single-compartment MIRD), or 300 \~ 1000 Gy (multi-compartment MIRD). minimal tumor dose by partition dosimetry : 100Gy Software: Simplicit90Y for planning, Y90 PET/CT the next day for post-treatment dosimetry. Follow-up: 1 year; additional treatments follow institutional guidelines. This streamlined approach maximizes efficiency while maintaining safety in selected patients.

Key facts

Study ID: NCT07043387
Run by: Seoul National University Hospital
People needed: 60
Starts: 2025-06-22
Expected to finish: 2029-06-30
Last updated by the study team: 2025-07-24

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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 it is running

Seoul National University Hospital — Seoul, South Korea (enrolling)
National Cancer Center — Goyang-si, South Korea
Samsung Medical Center — Seoul, South Korea
Severance hospital — Seoul, South Korea

Full record on ClinicalTrials.gov

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