Actively Recruiting

Age: 19Years +
All Genders
NCT07043387

Streamlining Radioembolization for CCC and Metastatic Liver Cancer

Led by Seoul National University Hospital · Updated on 2025-07-24

60

Participants Needed

4

Research Sites

209 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Streamlining Radioembolization for CCC and Metastatic Liver Cancer

Who Can Participate

Age: 19Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult aged 19 and over
  • Diagnosed with metastatic liver cancer or cholangiocarcinoma
  • Largest tumor diameter 7 cm or less
  • No more than 5 tumors
  • Future liver remnant volume greater than 30% of total non-tumorous liver volume
  • No dysmorphic intratumoral vessels or vessels 3 mm or thinner if present
  • Child-Pugh class A liver function
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • No major organ dysfunction based on recent blood tests
  • Leukocytes between 1,000 and 20,000 per microliter
  • Hemoglobin 6.0 g/dL or higher (transfusion allowed)
  • Total bilirubin 2.0 mg/dL or less
  • Platelets 40,000 per microliter or higher
  • INR 2.0 or less if not taking anticoagulants
  • AST 800 IU/L or less
  • ALT 800 IU/L or less
  • Creatinine 2.5 mg/dL or less (no limit if on hemodialysis)
  • Life expectancy more than 3 months
  • Negative pregnancy test for women of childbearing age
  • Able to understand and provide written consent
Not Eligible

You will not qualify if you...

  • Hepatic vein invasion seen on dynamic CT or MRI
  • Hepatic vein enhancement on arterial phase CT or MRI
  • Dysmorphic intratumoral vessel larger than 3 mm on arterial phase CT or MRI
  • Presence of transjugular intrahepatic portosystemic shunt (TIPS)
  • Lobar portal vein enhancement on arterial phase CT or MRI due to arterioportal shunt
  • Main portal vein tumor thrombosis
  • Lung conditions that increase risk of fatal radiation pneumonitis (e.g., marked emphysema or interstitial lung disease)
  • Presence of biliary stent or bilioenteric anastomosis
  • History of severe allergy or intolerance to contrast agents
  • Contraindications to angiography or selective visceral catheterization

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 4 locations

1

National Cancer Center

Goyang-si, South Korea

Not Yet Recruiting

2

Samsung Medical Center

Seoul, South Korea

Not Yet Recruiting

3

Seoul National University Hospital

Seoul, South Korea

Actively Recruiting

4

Severance hospital

Seoul, South Korea

Not Yet Recruiting

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Research Team

H

Hyo-Cheol Kim, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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