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

Sponsor

Ochsner Health System (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05953961

Collaborator

Boston Scientific Corporation (Industry)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Carcinoma, Hepatocellular	Device: Therasphere 90Y Device: Microwave Ablation	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Aug 1, 2023

Anticipated Primary Completion Date :

Aug 1, 2026

Anticipated Study Completion Date :

Jan 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
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.	Device: Therasphere 90Y Transarterial Radioembolization
Active Comparator: Microwave Ablation Ablation performed with a high powered, gas cooled multi-antenna system targeting an ablative margin > 5mm.	Device: Microwave Ablation Microwave Ablation

Arm

Intervention/Treatment

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.

Device: Therasphere 90Y

Transarterial Radioembolization

Active Comparator: Microwave Ablation

Ablation performed with a high powered, gas cooled multi-antenna system targeting an ablative margin > 5mm.

Device: Microwave Ablation

Microwave Ablation

Outcome Measures

Primary Outcome Measures

Disease Progression [1-year]
Progression in disease staging according to the Barcelona Clinic Liver Cancer Staging Algorithm

Secondary Outcome Measures

Target Response Evaluation Criteria in Solid Tumors modified for HCC [60 - 120 days post-treatment]
Durable target tumor response rate
Time to Retreatment [1 year]
Duration of time following the first cycle treatment until the targeted tumor requires additional treatment
Duration of Response [1 year]
Duration of time after first cycle treatment the target tumor continues to respond to treatment

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Ochsner Health System
Boston Scientific Corporation

Investigators

Principal Investigator: Ari Cohen, MD, Ochsner Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ochsner Health System

ClinicalTrials.gov Identifier:

NCT05953961

Other Study ID Numbers:

2023.090
Sponsored Research Agreement

First Posted:

Jul 20, 2023

Last Update Posted:

Jul 20, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Yes

Keywords provided by Ochsner Health System

Yttrium-90

Hypoalbuminemia

Additional relevant MeSH terms:

Carcinoma

Carcinoma, Hepatocellular

Hypoalbuminemia

Study Results

No Results Posted as of Jul 20, 2023