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

Cancer Clinical Trial

Official title:

Northern Alberta Linac-MR Image-Guided Human Clinical Trials - 1

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04358913
• Other study ID #: IIT-0013
• Status: Recruiting
• Phase: N/A
• Start date: August 23, 2021
• Est. completion date: December 2024

Study information

• Verified date: January 2024
• Source: AHS Cancer Control Alberta
• Contact: Nawaid Usmani, MD
• Phone: 780-432-8518
• Email: Nawaid.Usmani[@]ahs.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Intervention

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.

Locations

Country	Name	City	State
Canada	Cross Cancer Institute	Edmonton	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
AHS Cancer Control Alberta

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of high-quality MR image data sets acquired for each major tumour site (prostate, liver, lung, CNS, and breast)	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.	Through study completion, approximately 1 year
Secondary	Quantify the patient experience on the Linac-MR	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.	After the first and last scan, up to 5 weeks