Streamlining Radioembolization for CCC and Metastatic Liver Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age19+
SponsorSeoul National University Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
patients with metastatic liver cancer or cholangiocarcinoma who are scheduled for radioembolization
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
60 Participants
are grouped into 1 trial groupGroup A: streamlining group
Trial outcomes
Primary outcomes
1
Objective response rate according to the localized RECIST criteria
Time frame
up to 1 yearSecondary outcomes
1
Overall survival (OS) rates
Time frame
From date of radioembolization until the date of death from any cause, assessed up to 60 months2
Progression free survival (PFS) rates according to RECIST and localized RECIST
Time frame
From date of radioembolization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months3
AE and serious adverse event (SAE) according to CTCAE v5.0
Time frame
Time of treatment up to 90 days after the initial treatment or subsequent anticancer treatment, whichever comes first4
The presence or absence of radiation pneumonitis diagnosed by chest simple X-ray or CT
Time frame
Time frame: Time of treatment up to 180 days after the initial treatment or subsequent anticancer treatment, whichever comes firstSponsors and contacts
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Source ClinicalTrials.gov