Streamlining Radioembolization for HCC ≤ 5 cm With Y90 Resin Microspheres : Multicenter Prospective Registry Study

Status: Recruiting
Location: See all (4) locations...
Study Type: Observational
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, tumor size \< 5cm), radioembolization is performed without MAA scan with SIR-Spheres. This prospective registry will prove that the selection criteria is accurate and streamlining radioembolization is feasible and safe.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: f
View:

• HCC can be diagnosed by AASLD guideline

• hepatocellular carcinoma 5cm or smaller

• 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)

Locations
Other Locations
Republic of Korea
National Cancer Center
RECRUITING
Goyang
Samsung Medical Center
NOT_YET_RECRUITING
Seoul
Seoul National University Hospital
RECRUITING
Seoul
Severance hospital
NOT_YET_RECRUITING
Seoul
Contact Information
Primary
Hyo-Cheol Kim, MD
radioembolization@snu.ac.kr
82-10-5136-5205
Time Frame
Start Date: 2025-06-10
Estimated Completion Date: 2029-12-31
Participants
Target number of participants: 146
Treatments
Streamlining group
radioembolization is performed without MAA scan
Related Therapeutic Areas
Sponsors
Leads: Seoul National University Hospital

This content was sourced from clinicaltrials.gov