Same-day Radioembolization for Large HCC

NCT06944483 | Recruiting

• 1 other identifier: 2503-051-1620
• Study Type: observational
• Target: 138
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Hepatocellular Carcinoma (HCC)

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 1

Secondary Outcomes (4)

• Objective response rate

  up to 1 year

• local progression-free survival

  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

  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

  From date of radioembolization until the date of death from any cause, assessed up to 60 months

Study Arms (1)

same-day group

planning angiography, MAA scan, and radioembolization was performed in a single day

Procedure: same-day radioembolization

Interventions

same-day radioembolization PROCEDURE

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.

same-day group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with hepatocellular carcinoma who are scheduled for radioembolization

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (4)

National Cancer Center

Goyang, South Korea

RECRUITING

Samsung Medical Center

Seoul, South Korea

NOT YET RECRUITING

Seoul National University Hospital

Seoul, South Korea

RECRUITING

Severance hospital

Seoul, South Korea

NOT YET RECRUITING

Related Publications (2)

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Central Study Contacts

Hyo-Cheol Kim, MD

CONTACT

82-10-5136-5205; radioembolization@snu.ac.kr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 8, 2025
• First Posted: April 25, 2025
• Study Start: April 25, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: April 9, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (4)