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

Cancer Clinical Trial

— MRL1  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04135794
• Other study ID #: 19-5843
• Status: Recruiting
• Start date: December 9, 2019
• Est. completion date: November 30, 2026

Study information

• Verified date: June 2024
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: November 30, 2026
• Est. primary completion date: November 30, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Locations

Country	Name	City	State
Canada	Princess Margaret Cancer Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local, regional and distant tumor control rates	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.	Up to 5 years post-radiotherapy
Primary	Disease-free and overall survival rates	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.	Up to 5 years post-radiotherapy
Primary	Complication rates measured using the Common Toxicity Criteria for Adverse Events	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.	Within 3 months of completing treatment
Secondary	Patient experience and anxiety related to MR imaging and adaptive RT with the MR	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	Immediately after first MRL treatment visit
Secondary	Patient experience and anxiety related to MR imaging and adaptive RT with the MR	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)	Immediately after last MRL treatment visit
Secondary	Patient experience and anxiety related to MR imaging and adaptive RT with the MR	Evaluate the patient experience during adaptive RT with the MRL using -The EORTC QLQ C30 quality of life questionnaire	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)
Secondary	Patient experience and anxiety related to MR imaging and adaptive RT with the MR	Evaluate the patient experience during adaptive RT with the MRL using complete the Edmonton Symptom Assessment Scale revised version (ESAS-r)	each ambulatory care and radiation treatment review clinic visit (up to 5 years post treatment)