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

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Procedure
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), 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.

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

• HCC can be diagnosed by AASLD guideline

• 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)

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: 2025-04-25
Estimated Completion Date: 2029-12-31
Participants
Target number of participants: 138
Treatments
same-day group
planning angiography, MAA scan, and radioembolization was performed in a single day
Related Therapeutic Areas
Sponsors
Leads: Seoul National University Hospital

This content was sourced from clinicaltrials.gov