Same-day Radioembolization for Large HCC

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура 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

Первичные конечные точки

• percentage of execution of same-day radioembolization procedure [Срок оценки: Day 1]

Вторичные конечные точки (4)

• Objective response rate [Срок оценки: up to 1 year]
• local progression-free survival [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: From date of radioembolization until the date of death from any cause, assessed up to 60 months]

Критерии участия

Критерии включения

• Patients diagnosed with hepatocellular carcinoma histologically and/or radiologically (LI-RADS 4 or 5)
• hepatocellular carcinoma 5cm or larger
• dysmorphic intratumoral vessels 3mm or smaller
• Child-Pugh class A
• ECOG 0 or 1
• the following lab should be met. A. Leukocytes ≥ 1,000/µL and ≤ 20,000/µL B. Hemoglobin ≥ 6.0 g/dL (transfusion allowed to meet this criterion) C. Total bilirubin ≤ 2.0 mg/dL D. Platelet ≥ 40,000/µL E. International normalized ratio (INR) ≤ 2.0 for patients not taking anticoagulants F. Aspartate transaminase (AST) ≤ 800 IU/L (i.e., ≤ 20X upper normal limit) G. Alanine transaminase (ALT) ≤ 800 IU/L (i.e., ≤ 20X upper normal limit) H. Creatinine ≤ 2.5 mg/dL (if patient is receiving hemodialysis, no upper limit of creatinine)
• Patients with a life expectancy of >3 mo
• Patients who have adequately understood the clinical trial and consented in writing
• Nonpregnant women of childbearing potential

Критерии исключения

• hepatic vein invasion on CT/MRI
• Marked enhancement of portal vein or hepatic vein on arterial phase of CT/MRII
• TIPS
• dysmorphic intratumoral vessels > 3mm
• main portal vein invasion
• significant COPD or interstitial lung disease
• biliary stent or enterobiliary anastomosis

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Только случаи

Центры проведения

South Korea · 4 центра

• National Cancer Center — Goyang
• Samsung Medical Center — Seoul
• Seoul National University Hospital — Seoul
• Severance hospital — Seoul

Публикации

• Kim HC, Suh M, Paeng JC, Choi JW. Same-Day versus Multiday Planning/Treatment Radioembolization with Yttrium-90 Resin Microspheres in Patients with Liver Cancer >/=5 cm. J Vasc Interv Radiol. 2025 Dec;36(12):2010-2020.e2. doi: 10.1016/j.jvir.2025.08.028. Epub 2025 Aug 27. PMID 40882836
• Choi TW, Joo I, Kim HC. Association of dysmorphic intratumoral vessel with high lung shunt fraction in patients with hepatocellular carcinoma. Sci Rep. 2022 Aug 21;12(1):14248. doi: 10.1038/s41598-022-18697-5. PMID 35989374

Идентификаторы

NCT: NCT06944483 · 2503-051-1620

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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