Northern Alberta Linac-MR Image-Guided Radiotherapy (Northern LIGHTs-2)

NCT05413473 | Recruiting Phase 1 DMC

• 1 other identifier: IIT-0019
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

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). This new Linac-MR is a unique innovation at the Cross Cancer Institute, with theoretical advantages over other Linac-MR machines that are being tested elsewhere in the world. This feasibility study is being done as a first step in clinical development of the Linac-MR, as this new technology has to be tested to see if it is acceptable to both doctors and participants. The purpose of this Phase I/II study is (1) to verify treatment completion as intended and scheduled the oncology team, and (2) to evaluate treatment effects, including any expected or unexpected radiation side effects and cancer response to radiation. This study will allow the researchers at the Cross Cancer Institute to develop this technology further by conducting additional studies to take advantage of MRI scanning on tumor tracking during radiation treatments.

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

• Proportion of planned radiotherapy fractions that are administered, without clinically unacceptable interruptions, with the Alberta linac-MR P3 system.

  The total number of planned radiotherapy fractions that are administered, without clinically unacceptable interruptions, on the Alberta linac-MR P3 system. The study will track the number of planned fractions administered per participant without any significant interruptions or delays in their treatment.

  Approximately 6 years

Secondary Outcomes (8)

• Incidence of acute toxicity

  6 months post treatment

• Incidence of late toxicity

  between 6 months and 2 years post treatment

• Quantify the patient experience on the Linac-MR

  1 year post treatment

• Overall treatment time

  1 year post treatment

• Overall treatment planning time

  1 year post treatment

Study Arms (1)

MR guided radiotherapy

EXPERIMENTAL

MR-guided radiotherapy using the Alberta linac-MR P3 system. Contemporary radiotherapy techniques and fractionation schedules will be conducted in the following graduated stages with overlap between stages allowed: Stage 1: Parallel-opposed pair treatments (palliative) Stage 2: 4 field box treatments (curative or palliative) Stage 3: High dose treatments - multi-field 3DCRT (curative or palliative) Stage 4: High dose treatments - multi-field IMRT (curative or palliative)

Device: MR guided radiotherapy

Interventions

MR guided radiotherapy DEVICE

MR guided radiotherapy using the Alberta linac-MR P3 system

Also known as: Alberta linac-MR P3 system

MR guided radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults ≥ 18 years of age
• Patients deemed fit to undergo external beam radiation therapy by their attending radiation oncologist
• Accessible for follow-up

You may not qualify if:

• Patients with contraindications for MRI
• Patients who are unable to lie flat and still for the duration of the expected scan acquisition and treatment
• Patients who are unable to provide informed consent
• Patients with clinically significant inferior treatment plans compared to standard CT based external beam plans. For example, plans that generate hot spots of \> 110% or other unacceptable treatment plans that would not otherwise arise with standard CT based external beam plans.
• Pregnancy

Sponsors & Collaborators

• AHS Cancer Control Alberta: lead

Study Sites (1)

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

• Nawaid Usmani, MD

  Cross Cancer Institute, Alberta Health Services

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nawaid Usmani, MD

CONTACT

780-432-8518; Nawaid.Usmani@ahs.ca

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2022
• First Posted: June 10, 2022
• Study Start: February 8, 2023
• Primary Completion (Estimated): March 31, 2029
• Study Completion (Estimated): January 1, 2030
• Last Updated: June 15, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)