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Streamlining Radioembolization for Intrahepatic Cholangiocarcinoma

NCT07043348 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 1

Last updated 2025-07-20

No results posted yet for this study

Summary

Streamlining TARE for Small IHCC

TARE delivers radioactive microspheres (20-60 µm) to tumors via abnormal vasculature, while normal liver sinusoids (\<15 µm) block their passage. However, microspheres may enter hepatic veins and reach the lungs, risking radiation pneumonitis. To prevent this, pre-procedural angiography and MAA-based nuclear imaging assess the lung shunt fraction (LSF). TARE is contraindicated if LSF \>20% and used cautiously if 10-20%.

Large tumors, hepatic vein invasion, TIPS, and dysmorphic intratumoral vessels suggest high LSF. Dysmorphic vessels are rare in IHCC, an adenocarcinoma with typically low vascularity. Based on 10 years of data from Seoul National University Hospital, IHCC \<7 cm without vein invasion or dysmorphic vessels consistently shows LSF \<5%, with no cases of radiation pneumonitis. Thus, "streamlining TARE"-omitting nuclear imaging-is safely performed in this population to reduce procedural delays.

SIR-Spheres (SIRTEX), provided in a mother vial, enable single-session TARE without advance dosimetry, unlike TheraSphere (Boston Scientific), which requires prior preparation.

Protocol (n=40):

Procedure: Angiography, cone-beam CT, and TARE on the same day.

Dosimetry: Lung dose assumed 5%, capped at 10 Gy. Target absorbed dose \~250 Gy (single-compartment MIRD) or ≥300 Gy (boosted TARE, multi-compartment).

Software: Simplicit90Y for planning; Y90 PET/CT for post-treatment dosimetry.

Follow-up: 1 year; additional treatment as per institutional guidelines.

This streamlined protocol increases efficiency while maintaining safety in selected IHCC patients.

Conditions

  • Intrahepatic Cholangiocarcinoma (Icc)

Sponsors & Collaborators

  • Seoul National University Hospital

    lead OTHER

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-22
Primary Completion
2025-07-17
Completion
2025-07-17

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07043348 on ClinicalTrials.gov