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MRI-guided Holmium-166 Radioembolization (EMERITUS-2)

Primary Purpose

Primary Liver Cancer, Non-Resectable Hepatocellular Carcinoma

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
MRI-guided radioembolization
Sponsored by
Radboud University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Liver Cancer focused on measuring hepatocellular carcinoma, radioembolization, TARE

Eligibility Criteria

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

Inclusion Criteria: Diagnosis of hepatocellular carcinoma BCLC stage B or C At least one lesion of 10 mm or more in the longest diameter on contrast-enhanced MRI/CT Patient is eligible for TARE as determined by the tumour board (in Dutch: MDO) Patient has a life expectancy of 12 weeks or longer Patient has a WHO performance score of 0-2 Exclusion Criteria: Extrahepatic disease that cannot be targeted during the TARE session (enlarged lymph nodes in the liver hilus are allowed) Radiation therapy, chemotherapy or major surgery within 4 weeks before treatment Serum bilirubin > 2.0 x the upper limit of normal ALAT, ASAT, alkaline phosphatase (AF) > 5x the upper limit of normal Leukocytes <4.0 * 109/L or platelet count <60 * 109/L Significant heart disease that in the opinion of the physician increases the risk of ventricular arrhythmia. Pregnancy or breast feeding Disease with increased chance of liver toxicity, such as primary biliary cirrhosis or xeroderma pigmentosum Patients ineligible to undergo MR-imaging (claustrophobia, metal implants, etc) Portal vein thrombosis of the main branch (more distal branches are allowed) Untreated, active hepatitis Body weight > 150 kg (because of maximum table load) Severe allergy for i.v. contrast (Iomeron, Dotarem and/or Primovist) Lung shunt > 30 Gy, as calculated using scout dose 166Ho SPECT/CT. Uncorrectable extrahepatic deposition of scout dose activity. Activity in the falciform ligament, portal lymph nodes or gallbladder are accepted. Unstable final catheter position due to hepatic artery anatomy, which might lead to dislocation of the catheter during transfer to the MRI.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    MRI-guided radioembolization

    Arm Description

    Study patients will receive radioembolization with holmium microspheres in an MRI guided setting.

    Outcomes

    Primary Outcome Measures

    Toxicity profile of dose administration cohorts
    Determine a safe maximal healthy liver dose for personalised administration of microspheres based on (S)AEs related to liver toxicity due to radioembolisation.
    Safety of MRI-guided radioembolization procedure
    Monitoring (S)AE's related to the investigated combination of MRI-guided 166Ho radioembolization.
    Time constraints of performing intraprocedural MRI-based dosimetry
    Time constraints for image processing in between administration of microspheres, in order to be able to perform the procedure within half a day.
    Feasibility of performing intraprocedural treatment planning
    The ability of deciding on catheter positions and dose aministration during the procedure based on MRI dosimetry by comparing the standard of care treatment plan to the treatment performed during the study.

    Secondary Outcome Measures

    Dosimetry optimization
    Perform optimization of holmium dosimetry using SPECT and MRI

    Full Information

    First Posted
    October 26, 2022
    Last Updated
    November 1, 2022
    Sponsor
    Radboud University Medical Center
    Collaborators
    Terumo Medical Corporation
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05609448
    Brief Title
    MRI-guided Holmium-166 Radioembolization
    Acronym
    EMERITUS-2
    Official Title
    Real-time MR Imaged Treatment With Holmium Microspheres of Patients With Primary Liver Cancer; a Single Center, Interventional, Non-randomized, Feasibility Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 2023 (Anticipated)
    Primary Completion Date
    January 2025 (Anticipated)
    Study Completion Date
    October 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Radboud University Medical Center
    Collaborators
    Terumo Medical Corporation

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    To investigate the safety and feasibility of a personalized Ho-166-PLLA-MS TARE approach by using MRI guidance in inoperable patients with HCC.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Primary Liver Cancer, Non-Resectable Hepatocellular Carcinoma
    Keywords
    hepatocellular carcinoma, radioembolization, TARE

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    15 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    MRI-guided radioembolization
    Arm Type
    Experimental
    Arm Description
    Study patients will receive radioembolization with holmium microspheres in an MRI guided setting.
    Intervention Type
    Procedure
    Intervention Name(s)
    MRI-guided radioembolization
    Intervention Description
    Catheter placement will be performed using fluoroscopy, after which patients are transferred to the MRI scanner, where holmium microspheres are administered based on MRI dosimetry. Thereby, patients get a personalized dose administration.
    Primary Outcome Measure Information:
    Title
    Toxicity profile of dose administration cohorts
    Description
    Determine a safe maximal healthy liver dose for personalised administration of microspheres based on (S)AEs related to liver toxicity due to radioembolisation.
    Time Frame
    12 months after treatment
    Title
    Safety of MRI-guided radioembolization procedure
    Description
    Monitoring (S)AE's related to the investigated combination of MRI-guided 166Ho radioembolization.
    Time Frame
    12 months after treatment
    Title
    Time constraints of performing intraprocedural MRI-based dosimetry
    Description
    Time constraints for image processing in between administration of microspheres, in order to be able to perform the procedure within half a day.
    Time Frame
    during treatment procedure
    Title
    Feasibility of performing intraprocedural treatment planning
    Description
    The ability of deciding on catheter positions and dose aministration during the procedure based on MRI dosimetry by comparing the standard of care treatment plan to the treatment performed during the study.
    Time Frame
    during treatment procedure
    Secondary Outcome Measure Information:
    Title
    Dosimetry optimization
    Description
    Perform optimization of holmium dosimetry using SPECT and MRI
    Time Frame
    12 months after treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Diagnosis of hepatocellular carcinoma BCLC stage B or C At least one lesion of 10 mm or more in the longest diameter on contrast-enhanced MRI/CT Patient is eligible for TARE as determined by the tumour board (in Dutch: MDO) Patient has a life expectancy of 12 weeks or longer Patient has a WHO performance score of 0-2 Exclusion Criteria: Extrahepatic disease that cannot be targeted during the TARE session (enlarged lymph nodes in the liver hilus are allowed) Radiation therapy, chemotherapy or major surgery within 4 weeks before treatment Serum bilirubin > 2.0 x the upper limit of normal ALAT, ASAT, alkaline phosphatase (AF) > 5x the upper limit of normal Leukocytes <4.0 * 109/L or platelet count <60 * 109/L Significant heart disease that in the opinion of the physician increases the risk of ventricular arrhythmia. Pregnancy or breast feeding Disease with increased chance of liver toxicity, such as primary biliary cirrhosis or xeroderma pigmentosum Patients ineligible to undergo MR-imaging (claustrophobia, metal implants, etc) Portal vein thrombosis of the main branch (more distal branches are allowed) Untreated, active hepatitis Body weight > 150 kg (because of maximum table load) Severe allergy for i.v. contrast (Iomeron, Dotarem and/or Primovist) Lung shunt > 30 Gy, as calculated using scout dose 166Ho SPECT/CT. Uncorrectable extrahepatic deposition of scout dose activity. Activity in the falciform ligament, portal lymph nodes or gallbladder are accepted. Unstable final catheter position due to hepatic artery anatomy, which might lead to dislocation of the catheter during transfer to the MRI.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Meike van Wijk, MSc.
    Phone
    +31243617834
    Email
    meike.vanwijk@radboudumc.nl
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Frank Nijsen, PhD
    Organizational Affiliation
    Radboud University Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Data is available to other researchers upon reasonable request

    Learn more about this trial

    MRI-guided Holmium-166 Radioembolization

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