Northern Alberta Linac-MR Image-Guided Radiotherapy (Northern LIGHTs-2)
ConditionCancer
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAHS Cancer Control Alberta
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults ≥ 18 years of age
Patients deemed fit to undergo external beam radiation therapy by their attending radiation oncologist
Accessible for follow-up
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
MR guided radiotherapy
DeviceMR guided radiotherapy using the Alberta linac-MR P3 system
Treatment groups
99 Participants
are divided into 1 treatment groupGroup A: MR guided radiotherapyExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
Approximately 6 yearsSecondary outcomes
1
Incidence of acute toxicity
Acute toxicity (within 6 months post treatment) graded according to CTCAE version 5.0 will be assessed when all participants have completed a minimum of 1 year follow-up.
Time frame
6 months post treatment2
Incidence of late toxicity
Late toxicity (greater than 6 months post treatment) graded according to CTCAE version 5.0 will be assessed when all participants have completed a minimum of 1 year follow-up.
Time frame
between 6 months and 2 years post treatment3
Quantify the patient experience on the Linac-MR
Participants will complete a questionnaire at the end of their MR guided radiotherapy. The questionnaire will assess participant comfort and their perception of the treatment experience using a 1 - 5 scale.
Time frame
1 year post treatment4
Overall treatment time
The total MR guided radiotherapy time will be recorded for each participant, which is comprised of the sum of time the participant is in the treatment room and the total treatment time daily. The overall treatment duration should not exceed the original scheduled treatment duration via conventional radiotherapy by more than five business days, in case of unexpected servicing needs or any other delays.
Time frame
1 year post treatmentSponsors and contacts
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Source ClinicalTrials.gov