90Y Transarterial Radioembolization Versus Microwave Abla... | NCT05953961

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

NCT05953961

Sponsor

Ochsner Health System

Status

Recruiting

Last Update Posted

Aug 3, 2025Actual

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Carcinoma, Hepatocellular

Interventions

Therasphere 90Y
Microwave Ablation

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
Sponsored Research Agreement	Other Grant/Funding Number	Boston Scientific

Status Module

Record Verification Date

Jul 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 8, 2023Actual

Primary Completion Date

Aug 2026Estimated

Completion Date

Jan 2027Estimated

First Submitted Date

Jul 12, 2023

First Submission Date that Met QC Criteria

Jul 12, 2023

First Posted Date

Jul 20, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 30, 2025

Last Update Posted Date

Aug 3, 2025Actual

Name	Class
Boston Scientific Corporation	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

This study will compare 1-year outcomes in patients with hypoalbuminemia and a new diagnosis of early-stage hepatocellular carcinoma (HCC) who are candidates for both 90-Yittrium Therasphere transarterial radioembolization (90Y) and microwave ablation (MWA). The study will focus on patients with solitary, small HCC, defined as a single tumor ≤ 3cm in diameter, and with hypoalbuminemia at the time of HCC diagnosis, defined as albumin < 3.4 g/dL. Participants will be randomized to receive either 90Y or MWA as a first cycle liver-directed therapy.

The study will enroll 50 participants randomized at a 1:1 ratio to 90Y or MWA. After first cycle treatment, the participants will resume standard of care management for early-stage HCC. Participants will undergo observational follow-up for 1-year after first cycle treatment to collect data on adverse events, response to treatment, time to retreatment, duration of response, and progression of disease staging.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Therasphere 90Y	Device	Transarterial Radioembolization	Therasphere Transarterial Radioembolization

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Disease Progression	Progression in disease staging according to the Barcelona Clinic Liver Cancer Staging Algorithm	1-year

Secondary Outcomes

Measure	Description	Time Frame
Target Response Evaluation Criteria in Solid Tumors modified for HCC	Durable target tumor response rate	60 - 120 days post-treatment
Time to Retreatment	Duration of time following the first cycle treatment until the targeted tumor requires additional treatment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ken Bode	Contact	5048421936		ken.bode@ochsner.org
Amy Riehm	Contact	5047039065		amyriehm@ochsner.org

Overall Officials

Name	Affiliation	Role
Ari Cohen, MD	Ochsner Health	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ochsner Main Campus	Recruiting	New Orleans	Louisiana	70121	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006528	Carcinoma, Hepatocellular
D034141	Hypoalbuminemia

Ancestor Terms

ID	Term
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided