NCT05413473 Northern Alberta Linac-MR Image-Guided Radiotherapy (Northern LIGHTs-2)
| NCT ID | NCT05413473 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | AHS Cancer Control Alberta |
| Condition | Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 99 participants |
| Start Date | 2023-02-08 |
| Primary Completion | 2029-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 99 participants in total. It began in 2023-02-08 with a primary completion date of 2029-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * Adults ≥ 18 years of age * Patients deemed fit to undergo external beam radiation therapy by their attending radiation oncologist * Accessible for follow-up Exclusion Criteria: * 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
Contact & Investigator
Nawaid Usmani, MD
PRINCIPAL INVESTIGATOR
Cross Cancer Institute, Alberta Health Services
Frequently Asked Questions
Who can join the NCT05413473 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05413473 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05413473 currently recruiting?
Yes, NCT05413473 is actively recruiting participants. Contact the research team at Nawaid.Usmani@ahs.ca for enrollment information.
Where is the NCT05413473 trial being conducted?
This trial is being conducted at Edmonton, Canada.
Who is sponsoring the NCT05413473 clinical trial?
NCT05413473 is sponsored by AHS Cancer Control Alberta. The principal investigator is Nawaid Usmani, MD at Cross Cancer Institute, Alberta Health Services. The trial plans to enroll 99 participants.
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