NCT06944483

Same-day Radioembolization for Large HCC

Same-day Radioembolization for Large HCC (>5cm) With Y90 Resin Microspheres : Multicenter Prospective Registry Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 138 (estimated)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Hepatocellular Carcinoma (HCC)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-04-25
• Primary completion: 2028-12-31
• Completion: 2029-12-31
• First posted: 2025-04-25
• Last updated: 2026-04-09

Locations

4 sites across 1 country: South Korea