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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04135794
Recruitment Status : Recruiting
First Posted : October 23, 2019
Last Update Posted : December 12, 2019
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

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
Cancer

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Study Type : Observational
Estimated 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 : December 9, 2019
Estimated Primary Completion Date : November 30, 2024
Estimated Study Completion Date : November 30, 2024



Primary Outcome Measures :
  1. Local, regional and distant tumor control rates [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients with cancer from any clinical site requiring radiotherapy
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04135794


Locations
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Canada, Ontario
Princess Margaret Cancer Centre Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Michael Milosevic, MD    4169464501 ext 4874    michael.milosevic@rmp.uhn.ca   
Sponsors and Collaborators
University Health Network, Toronto
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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT04135794    
Other Study ID Numbers: 19-5843
First Posted: October 23, 2019    Key Record Dates
Last Update Posted: December 12, 2019
Last Verified: December 2019

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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:
MRL