NCT07043387Recruiting
Streamlining Radioembolization for CCC and Metastatic Liver Cancer
Streamlining Radioembolization for Cholangiocarcinoma or Metastatic Liver Cancer ≤ 7 cm : Multicenter Prospective Registry Study
Source: ClinicalTrials.gov · Last updated 18 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 60 (estimated)
- First submitted
- 20 Jun 2025
- Start date
- 22 Jun 2025
- Primary completion date
- 30 Dec 2028
- Lead sponsor
- Seoul National University Hospital
- NCT number
- NCT07043387
What you commit to
- Study type: Observational
- Planned participants: 60
- From 22 Jun 2025 to the primary completion date, 30 Dec 2028
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
- History of severe allergy of intolerance to contrast agents
Other
- 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
- biliary stent or bilioenteric anastomosis
- Contraindication to angiography or selective visceral catheterization
Who the study is looking for
- 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
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Cancer Center Coordinator of this site? Confirm its status | Goyang-si | South Korea | Not yet recruiting |
| Severance hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Not yet recruiting |
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.