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

Primary Purpose

Carcinoma, Hepatocellular

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Therasphere 90Y
Microwave Ablation
Sponsored by
Ochsner Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma, Hepatocellular focused on measuring Yttrium-90, Hypoalbuminemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Therasphere Transarterial Radioembolization

    Microwave Ablation

    Arm Description

    Two-phase treatment including mapping angiogram with personalized dosimetry followed by complete treatment of the tumor angiosome with 90-Yittrium glass microsphere infusion.

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

    Outcomes

    Primary Outcome Measures

    Disease Progression
    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
    Durable target tumor response rate
    Time to Retreatment
    Duration of time following the first cycle treatment until the targeted tumor requires additional treatment
    Duration of Response
    Duration of time after first cycle treatment the target tumor continues to respond to treatment

    Full Information

    First Posted
    July 12, 2023
    Last Updated
    July 12, 2023
    Sponsor
    Ochsner Health System
    Collaborators
    Boston Scientific Corporation
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05953961
    Brief Title
    90Y Transarterial Radioembolization Versus Microwave Ablation in Small Hepatocellular Carcinoma With Hypoalbuminemia
    Acronym
    REALM
    Official Title
    Randomized Study of Therapshere 90-Yittrium Transarterial Radioembolization Versus Microwave Ablation in Small Hepatocellular Carcinoma With Hypoalbuminemia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 2023 (Anticipated)
    Primary Completion Date
    August 2026 (Anticipated)
    Study Completion Date
    January 2027 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Ochsner Health System
    Collaborators
    Boston Scientific Corporation

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Product Manufactured in and Exported from the U.S.
    Yes
    Data Monitoring Committee
    No

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Carcinoma, Hepatocellular
    Keywords
    Yttrium-90, Hypoalbuminemia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Therasphere Transarterial Radioembolization
    Arm Type
    Active Comparator
    Arm Description
    Two-phase treatment including mapping angiogram with personalized dosimetry followed by complete treatment of the tumor angiosome with 90-Yittrium glass microsphere infusion.
    Arm Title
    Microwave Ablation
    Arm Type
    Active Comparator
    Arm Description
    Ablation performed with a high powered, gas cooled multi-antenna system targeting an ablative margin > 5mm.
    Intervention Type
    Device
    Intervention Name(s)
    Therasphere 90Y
    Intervention Description
    Transarterial Radioembolization
    Intervention Type
    Device
    Intervention Name(s)
    Microwave Ablation
    Intervention Description
    Microwave Ablation
    Primary Outcome Measure Information:
    Title
    Disease Progression
    Description
    Progression in disease staging according to the Barcelona Clinic Liver Cancer Staging Algorithm
    Time Frame
    1-year
    Secondary Outcome Measure Information:
    Title
    Target Response Evaluation Criteria in Solid Tumors modified for HCC
    Description
    Durable target tumor response rate
    Time Frame
    60 - 120 days post-treatment
    Title
    Time to Retreatment
    Description
    Duration of time following the first cycle treatment until the targeted tumor requires additional treatment
    Time Frame
    1 year
    Title
    Duration of Response
    Description
    Duration of time after first cycle treatment the target tumor continues to respond to treatment
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ken Bode
    Phone
    5048421936
    Email
    ken.bode@ochsner.org
    First Name & Middle Initial & Last Name or Official Title & Degree
    Amy Riehm
    Phone
    5047039065
    Email
    amyriehm@ochsner.org
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ari Cohen, MD
    Organizational Affiliation
    Ochsner Health
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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