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MR Imaging Study Using the Northern Alberta Linac-MR (Northern LIGHTs - 1)

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: NCT04358913
Recruitment Status : Recruiting
First Posted : April 24, 2020
Last Update Posted : January 18, 2023
Sponsor:
Information provided by (Responsible Party):
AHS Cancer Control Alberta

Study Description
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Brief Summary:
Cancers are often treated with external beam radiotherapy. Current radiotherapy treatments are performed using computed tomography (also known as CT) scans which may not always clearly identify the cancer. In some instances, magnetic resonance imaging (MRI) may be able to better identify cancers. Therefore, efforts are currently underway to use the MRI scans to improve radiotherapy treatments or eventually even use radiotherapy equipment that only uses MRI scans to guide treatments. This new technology that will only use MRI scans to guide treatments is called the Linac-MR (linear accelerator with an MRI). The purpose of this pilot phase of the study is to test whether the Alberta linac-MR P3 system at the Cross Cancer Institute can acquire high quality MR images safely. It will allow the researchers to develop the best collection of MR images possible with this new machine, in order to allow them to visualize tumors for future patients that are treated on this machine.

Condition or disease Intervention/treatment Phase
Cancer Device: MR scan with the Alberta linac-MR P3 system Not Applicable

Detailed Description:
This prospective, pilot phase, clinical trial is an imaging study to optimize the necessary MR sequences on the Alberta linac-MR P3 system to allow for MR-guided radiotherapy in adult patients with cancer that are treated with high dose external beam radiotherapy. Each participant will undergo a single MR imaging session (30 - 40 minutes) on the Alberta linac-MR P3 system. Towards the end of the study, patients will be approached to participate in an optional sub-study, where they will undergo a total of five MR imaging sessions (performed every two to five days) to allow for an assessment of inter-fraction motion.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Northern Alberta Linac-MR Image-Guided Human Clinical Trials - 1
Actual Study Start Date : August 23, 2021
Estimated Primary Completion Date : August 2023
Estimated Study Completion Date : August 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: MR Imaging on the Alberta linac-MR P3 system
All participants will undergo a single MR imaging session (30-40 minutes) on the Alberta linac-MR P3 system.
 Device: MR scan with the Alberta linac-MR P3 system
Single MR imaging session to develop and optimize the necessary MR sequences on the Alberta linac-MR P3 system to allow for MR-guided radiotherapy.


Outcome Measures
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Primary Outcome Measures :
  1. Number of high-quality MR image data sets acquired for each major tumour site (prostate, liver, lung, CNS, and breast) [ Time Frame: Through study completion, approximately 1 year ]
    Clinical radiologists, medical physicists, and radiation oncologists will work together to develop MR sequences that can delineate tumour target volumes on the Alberta linac-MR P3 system. Over the course of the trial, the clinical radiologists will work with medical physicists to optimize these sequences to allow for the development of optimal MR images, with the goal to develop of series of protocols that can be utilized to provide clear MR image guidance for each tumour group.


Secondary Outcome Measures :
  1. Quantify the patient experience on the Linac-MR [ Time Frame: After the first and last scan, up to 5 weeks ]
    Participants will complete a questionnaire at the end of their first scan regarding their experience having imaging done on the Linac-MR. Participants taking part in the optional sub-study will complete the same questionnaire at the end of their last set of imaging.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults ≥ 18 years of age
  • Patients deemed fit to undergo high dose external beam radiation therapy by their attending radiation oncologist

Exclusion Criteria:

  • Patients with contraindications for MRI
  • Patients who are unable to lie flat and still for the duration of the expected scan acquisition
  • Patients who are unable to provide informed consent
Contacts and Locations
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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): NCT04358913


Contacts
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Contact: Nawaid Usmani, MD 780-432-8518 Nawaid.Usmani@ahs.ca

Locations
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Canada, Alberta
Cross Cancer Institute Recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Sponsors and Collaborators
AHS Cancer Control Alberta
Investigators
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Principal Investigator: Nawaid Usmani, MD Cross Cancer Institute, Alberta Health Services
More Information
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Responsible Party: AHS Cancer Control Alberta
ClinicalTrials.gov Identifier: NCT04358913    
Other Study ID Numbers: IIT-0013
First Posted: April 24, 2020    Key Record Dates
Last Update Posted: January 18, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No