Recruiting
Phase 1
Phase 2

Radiotherapy

Sponsor:

AHS Cancer Control Alberta

Code:

NCT05413473

Conditions

Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

MR guided radiotherapy

Study Details

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

Study ID

NCT05413473

Start date

Feb 8, 2023

Status verified date

Jun, 2025

Completion date

Jan, 2030

Anticipated

Primary completion date

Mar 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

99 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: MR guided radiotherapy

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)

Interventions

MR guided radiotherapy

MR guided radiotherapy using the Alberta linac-MR P3 system

Primary outcome measure

  • Proportion of planned radiotherapy fractions that are administered, without clinically unacceptable interruptions, with the Alberta linac-MR P3 system. [ Time Frame: Approximately 6 years ]

Central Contacts and Locations

Central contacts

Locations

Cross Cancer Institute

Recruiting

Edmonton, Alberta, Canada, T6G 1Z2

More Information

Sponsor

AHS Cancer Control Alberta

Last update posted

Jun 15, 2025

Last verified

Jun, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by AHS Cancer Control Alberta on 2025-06-15.