Randomized Study of Therapshere 90-Yittrium Transarterial Radioembolization Versus Microwave Ablation in Small Hepatocellular Carcinoma With Hypoalbuminemia

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Louisiana
Ochsner Main Campus
RECRUITING
New Orleans
Contact Information
Primary
Ken Bode
ken.bode@ochsner.org
5048421936
Backup
Amy Riehm
amyriehm@ochsner.org
5047039065
Time Frame
Start Date: 2023-08-08
Estimated Completion Date: 2027-01
Participants
Target number of participants: 50
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: Boston Scientific Corporation
Leads: Ochsner Health System

This content was sourced from clinicaltrials.gov