An observational study in Hepatocellular Carcinoma (HCC), sponsored by Seoul National University Hospital. Recruiting at 4 sites in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-08-18.
Sponsored by Seoul National University Hospital · Observational
In patients who has no sign suggesting high lung shunt fraction (TIPS, hepatic vein invasion, hepatic vein enhancement on arterial phase, dysmorphic intratumoral vessel), planning angiography, MAA scan, and radioembolization are performed in a single day with SIR-Spheres. This prospective registry will prove that the selection criteria is accurate and same-day radioembolization is feasible and safe.
SIR-Spheres (SIRTEX): A mother vial containing ≥7 GBq is delivered to the hospital, and the treatment team divides it into daughter vials with specific radiation activities tailored to the target vessels. This allows for same-day TARE, in which lung shunt evaluation, vessel identification, dose calculation, and microsphere injection are all conducted on the same day.
This approach is referred to as same-day TARE.
To implement same-day TARE effectively, it is crucial to carefully select patients who are expected to have a low lung shunt fraction. This helps minimize the waste of pre-ordered SIR-Spheres vials that would otherwise go unused. Factors associated with a high lung shunt fraction include large tumor size, hepatic vein invasion, the presence of a transjugular intrahepatic portosystemic shunt (TIPS), and dysmorphic intratumoral vessels. In patients with tumors larger than 5 cm, the lung shunt fraction is likely to be low if there is no hepatic vein invasion, no TIPS, and no dysmorphic intratumoral vessels. Therefore, by selecting patients without dysmorphic intratumoral vessels for same-day TARE, it is possible to avoid wasting SIR-Spheres vials and perform the procedure without delays in treatment.
Furthermore, by defining safe and effective dose ranges for lung dose, tumor dose, and perfused liver dose, a standardized TARE protocol can be established. Through this study, we aim to establish appropriate patient selection criteria for same-day TARE and to standardize TARE dosimetry.
3,182 studies on the registry are indexed under Carcinoma, Hepatocellular; 954 are open to participants now.
This study's planned enrollment of 138 is below the median of 200 across 754 observational studies indexed under Carcinoma, Hepatocellular.
Browse Carcinoma, Hepatocellular studies →Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
patients with hepatocellular carcinoma who are scheduled for radioembolization
Exclusion Criteria:
planning angiography, MAA scan, and radioembolization was performed in a single day
Procedure: same-day radioembolization
On the day of the procedure, angiography is performed, followed by cone-beam CT of the hepatic artery. After injecting 99mTc-MAA into the hepatic artery, the patient is transferred to the nuclear medicine department for a lung shunt scan and lung SPECT/CT. The lung shunt fraction is determined using the planar images. Using diagnostic CT/MRI and 99mTc-MAA images, the treatment dose is calculated with the multi-compartment MIRD method. The acceptable range for tumor absorbed dose is ≥100 Gy, and the lung dose must be ≤15 Gy. The tumor absorbed dose must be at least 100 Gy and should ideally be within the range of 300 to 600 Gy. There is no upper limit for the tumor absorbed dose.
percentage of execution of same-day radioembolization procedure
Execution means that planning angiography, MAA scan and radioembolization are performed in a single day. The number same-day radioembolization is divided by total enrolled patient number.
Time frame: Day 1
Objective response rate
objective response rate
Time frame: up to 1 year
local progression-free survival
Time frame: From date of radioembolization until the date of first documented progression of treated tumor or date of death from any cause, whichever came first, assessed up to 60 months
Progression-free survival
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 months
overall survival
Time frame: From date of radioembolization until the date of death from any cause, assessed up to 60 months
Plan to share: No
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Seoul National University Hospital