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Recruiting NCT07043387

Streamlining Radioembolization for CCC and Metastatic Liver Cancer

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

Sex: All
Ages: 19 Years – N/A
Healthy volunteers: No
Enrollment: 60
Sponsor: Seoul National University Hospital

Location: National Cancer Center Goyang-si

Summary

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 (\

Eligibility 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

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07043387). StuddyBuddy aggregates publicly available trial information.