Actively Recruiting
Randomized Study of Therasphere 90-Yittrium Transarterial Radioembolization Versus Microwave Ablation in Small Hepatocellular Carcinoma With Hypoalbuminemia
Led by Ochsner Health System · Updated on 2025-08-03
50
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
Sponsors
O
Ochsner Health System
Lead Sponsor
B
Boston Scientific Corporation
Collaborating Sponsor
AI-Summary
What this Trial Is About
This clinical trial is studying patients with hypoalbuminemia and a new diagnosis of small, early-stage hepatocellular carcinoma (HCC). It aims to compare outcomes between two liver-directed treatments to see if 90-Yittrium Therasphere transarterial radioembolization (90Y) reduces the risk of disease progression within one year after diagnosis. The focus is on patients with a single tumor 3 cm or smaller and albumin levels below 3.4 g/dL at diagnosis. Participants are randomly assigned to receive either 90Y or microwave ablation (MWA) as their first liver-directed therapy. The 90Y treatment involves a two-phase process including a mapping angiogram with personalized dosimetry followed by infusion of 90-Yittrium glass microspheres targeting the tumor area. The MWA uses a high-powered, gas-cooled multi-antenna system to ablate the tumor with an ablative margin greater than 5 mm. After this initial treatment, participants continue with standard care for early-stage HCC. Throughout the study, participants are followed for one year after their first treatment cycle. Researchers will collect data on adverse events, treatment response, time to any retreatment, duration of response, and disease progression. The main measure is disease progression at one year, with additional evaluations done 60 to 120 days after treatment. This monitoring helps assess the safety and effects of the two treatments over time.
CONDITIONS
Brief Title
90Y Transarterial Radioembolization Versus Microwave Ablation in Small Hepatocellular Carcinoma With Hypoalbuminemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Diagnosis of hepatocellular carcinoma according to Liver Imaging - Reporting Data System criteria
- Eastern Cooperative Oncology Group score of 0 or 1
- Child-Pugh class A or B liver function
- Bilirubin level less than 2.5 mg/dL
- Creatinine level less than 2.0 mg/dL
- No prior liver-directed or systemic therapy for hepatocellular carcinoma
- Single unresectable liver tumor 3 cm or smaller
- Albumin level below 3.4 g/dL at diagnosis
- Tumor location suitable for both microwave ablation and 90-Yittrium treatment
You will not qualify if you...
- Pregnant women
- Having another active cancer at the same time
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Two-phase treatment including mapping angiogram and treatment or ablation procedure completed as per protocol
Participants receive either 90-Yittrium Therasphere transarterial radioembolization or microwave ablation as their first cycle liver-directed therapy.
2 visits for 90Y treatment or 1 visit for microwave ablation
Duration - 1 year
Participants are observed for 1 year after the first cycle treatment to collect data on adverse events, response to treatment, time to retreatment, and disease progression.
Follow-up visits for up to 1 year post-treatment
Trial Site Locations
Total: 1 location
1
Ochsner Main Campus
New Orleans, Louisiana, United States, 70121
Actively Recruiting
Research Team
K
Ken Bode
A
Amy Riehm
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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