90Y Transarterial Radioembolization Versus Microwave Ablation in Small Hepatocellular Carcinoma With Hypoalbuminemia

Part of paid clinical trials in New Orleans, Louisiana.

Sponsor
Ochsner Health System
Study ID
NCT05953961
Status
Recruiting
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Conditions

  • Carcinoma, Hepatocellular

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Therasphere 90Y — DEVICE
    Transarterial Radioembolization
  • Microwave Ablation — DEVICE
    Microwave Ablation

Study Details

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.

Key Dates

Start date
Aug 8, 2023
Status verified
Jul 2025
Primary completion
Aug 31, 2026
Completion
Jan 31, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Therasphere Transarterial Radioembolization
    Two-phase treatment including mapping angiogram with personalized dosimetry followed by complete treatment of the tumor angiosome with 90-Yittrium glass microsphere infusion.
  • Active Comparator: Microwave Ablation
    Ablation performed with a high powered, gas cooled multi-antenna system targeting an ablative margin \> 5mm.

Primary Outcome Measure

Disease Progression [ Time Frame: 1-year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Ochsner Main CampusNew OrleansLouisiana70121

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Ochsner Main Campus· New Orleans, LA

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