MRL1: Magnetic Resonance-Guided Adaptive Radiotherapy (MRgART) Using an Integrated Magnetic Resonance Linear Accelerator (MRL)

Sponsor
University Health Network, Toronto (Other)
Overall Status
Recruiting
CT.gov ID
NCT04135794
Collaborator
(none)
500
1
59.7
8.4

Study Details

Study Description

Brief Summary

This study is being done to help further understand how MR-guided adaptive RT in conjunction with the Integrated Magnetic Resonance Linear Accelerator (MRL) can improve patient outcomes. This study will include participants who will be receiving radiotherapy using the MRL machine to target their cancer more precisely. Participants will be asked to have a few extra MR scans taken during their RT planning and to complete a few quality of life questionnaires.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    500 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Magnetic Resonance-Guided Adaptive Radiotherapy (MRgART) Using an Integrated Magnetic Resonance Linear Accelerator (MRL)
    Actual Study Start Date :
    Dec 9, 2019
    Anticipated Primary Completion Date :
    Nov 30, 2024
    Anticipated Study Completion Date :
    Nov 30, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Local, regional and distant tumor control rates [Up to 5 years post-radiotherapy]

      Refine our understanding of clinical scenarios where MRgART with the MRL improves patient outcomes and translate this new knowledge and new treatment approach to widespread clinical practice through the development and validation of efficient, cost-effective treatment processes.

    2. Disease-free and overall survival rates [Up to 5 years post-radiotherapy]

      Refine our understanding of clinical scenarios where MRgART with the MRL improves patient outcomes and translate this new knowledge and new treatment approach to widespread clinical practice through the development and validation of efficient, cost-effective treatment processes.

    3. Complication rates measured using the Common Toxicity Criteria for Adverse Events [Within 3 months of completing treatment]

      Refine our understanding of clinical scenarios where MRgART with the MRL improves patient outcomes and translate this new knowledge and new treatment approach to widespread clinical practice through the development and validation of efficient, cost-effective treatment processes.

    Secondary Outcome Measures

    1. Patient experience and anxiety related to MR imaging and adaptive RT with the MR [Immediately after first MRL treatment visit]

      Evaluate the patient experience during adaptive RT with the MRL using the Magnetic Resonance Imaging-Anxiety Questionnaire (MRI-AQ) which measures patient anxiety and tolerability of MR-related procedures

    2. Patient experience and anxiety related to MR imaging and adaptive RT with the MR [Immediately after last MRL treatment visit]

      Evaluate the patient experience during adaptive RT with the MRL using the EORTC satisfaction with cancer care core questionnaire (EORTC PATSAT-C33) and specific complementary outpatient module (EORTC OUT-PATSAT7)

    3. Patient experience and anxiety related to MR imaging and adaptive RT with the MR [d prior to starting treatment with the MRL, immediately after the last MRL treatment, at the first follow-up visit and annually thereafter during follow-up (up to 5 years post treatment)]

      Evaluate the patient experience during adaptive RT with the MRL using -The EORTC QLQ C30 quality of life questionnaire

    4. Patient experience and anxiety related to MR imaging and adaptive RT with the MR [each ambulatory care and radiation treatment review clinic visit (up to 5 years post treatment)]

      Evaluate the patient experience during adaptive RT with the MRL using complete the Edmonton Symptom Assessment Scale revised version (ESAS-r)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Patients 18 years or older with a diagnosis of cancer, regardless of clinical site or stage

    • Planned to receive a course of MR-guided adaptive RT using the MRL

    • Ability to provide informed consent

    Exclusion Criteria:
    • Patients under 18 years old

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Princess Margaret Cancer Centre Toronto Ontario Canada M5G 2M9

    Sponsors and Collaborators

    • University Health Network, Toronto

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Health Network, Toronto
    ClinicalTrials.gov Identifier:
    NCT04135794
    Other Study ID Numbers:
    • 19-5843
    First Posted:
    Oct 23, 2019
    Last Update Posted:
    Oct 5, 2021
    Last Verified:
    Oct 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Health Network, Toronto

    Study Results

    No Results Posted as of Oct 5, 2021