Recruiting

90Y vs. MWA

Sponsor:

Ochsner Health System

Code:

NCT05953961

Conditions

Carcinoma, Hepatocellular

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Therasphere 90Y

Microwave Ablation

Study Details

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.

Conditions

Carcinoma, Hepatocellular

Study ID

NCT05953961

Start date

Aug 8, 2023

Status verified date

Jul, 2025

Completion date

Jan, 2027

Anticipated

Primary completion date

Aug, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Pregnant women
  • Concurrent malignancy

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Therasphere 90Y

Transarterial Radioembolization

Microwave Ablation

Microwave Ablation

Primary outcome measure

  • Disease Progression [ Time Frame: 1-year ]

Central Contacts and Locations

Central contacts

Ken Bode

5048421936ken.bode@ochsner.org

Amy Riehm

5047039065amyriehm@ochsner.org

Locations

Ochsner Main Campus

Recruiting

New Orleans, Louisiana, United States, 70121

Contacts

Ken Bode

ken.bode@ochsner.org

More Information

Sponsor

Ochsner Health System

Last update posted

Aug 3, 2025

Last verified

Jul, 2025

Keywords

  • Yttrium-90
  • Hypoalbuminemia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ochsner Health System on 2025-08-03.