90Y Transarterial Radioembolization Versus Microwave Ablation in Small Hepatocellular Carcinoma With Hypoalbuminemia
REALM
Randomized Study of Therapshere 90-Yittrium Transarterial Radioembolization Versus Microwave Ablation in Small Hepatocellular Carcinoma With Hypoalbuminemia
2 other identifiers
interventional
50
1 country
1
Brief Summary
This clinical trial will compare 1-year outcomes in patients with hypoalbuminemia and a new diagnosis of small, early-stage hepatocellular carcinoma (HCC) who are candidates for both 90-Yittrium Therasphere transarterial radioembolization (90Y) and microwave ablation (MWA). The study will determine whether treatment with 90Y lowers the risk of disease progression within the first year after diagnosis. Participants will be randomized to receive either first cycle 90Y or MWA and then proceed with standard of care.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2023
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 12, 2023
CompletedFirst Posted
Study publicly available on registry
July 20, 2023
CompletedStudy Start
First participant enrolled
August 8, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2027
August 3, 2025
July 1, 2025
3 years
July 12, 2023
July 30, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Disease Progression
Progression in disease staging according to the Barcelona Clinic Liver Cancer Staging Algorithm
1-year
Secondary Outcomes (3)
Target Response Evaluation Criteria in Solid Tumors modified for HCC
60 - 120 days post-treatment
Time to Retreatment
1 year
Duration of Response
1 year
Study Arms (2)
Therasphere Transarterial Radioembolization
ACTIVE COMPARATORTwo-phase treatment including mapping angiogram with personalized dosimetry followed by complete treatment of the tumor angiosome with 90-Yittrium glass microsphere infusion.
Microwave Ablation
ACTIVE COMPARATORAblation performed with a high powered, gas cooled multi-antenna system targeting an ablative margin \> 5mm.
Interventions
Eligibility Criteria
You may qualify if:
- HCC diagnosis according to the Liver Imaging - Reporting Data System (LI-RADS) Criteria as defined in the American Association for the Study of Liver Diseases 2018 HCC practice guidelines
- Eastern Cooperative Oncology Group score 0 - 1
- Child-Pugh A - B
- Bilirubin \< 2.5 mg/dL
- Creatinine \< 2.0 mg/dL
- No prior liver-directed therapy or systemic therapy for HCC
- Solitary, unresectable HCC ≤ 3cm
- Albumin level \< 3.4 g/dL at HCC diagnosis
- Tumor anatomical location and angiosome amendable to MWA and 90Y
You may not qualify if:
- Pregnant women
- Concurrent malignancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ochsner Health Systemlead
- Boston Scientific Corporationcollaborator
Study Sites (1)
Ochsner Main Campus
New Orleans, Louisiana, 70121, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ari Cohen, MD
Ochsner Health
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 12, 2023
First Posted
July 20, 2023
Study Start
August 8, 2023
Primary Completion (Estimated)
August 1, 2026
Study Completion (Estimated)
January 1, 2027
Last Updated
August 3, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share