NCT04358913

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). 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for not_applicable cancer

Timeline
32mo left

Started Aug 2021

Longer than P75 for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress65%
Aug 2021Jan 2029

First Submitted

Initial submission to the registry

April 9, 2020

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 24, 2020

Completed
1.3 years until next milestone

Study Start

First participant enrolled

August 23, 2021

Completed
7.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2029

Last Updated

May 14, 2025

Status Verified

May 1, 2025

Enrollment Period

7.4 years

First QC Date

April 9, 2020

Last Update Submit

May 9, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of high-quality MR image data sets acquired for each major tumour site (prostate, liver, lung, CNS, breast, gynecological, pancreas, and head and neck)

    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 7 years

Secondary Outcomes (1)

  • Quantify the patient experience on the Linac-MR

    After the first and last scan, up to 5 weeks

Study Arms (1)

MR Imaging on the Alberta linac-MR P3 system

EXPERIMENTAL

All participants will undergo a single MR imaging session (30-40 minutes) on the Alberta linac-MR P3 system.

Device: MR scan with the Alberta linac-MR P3 system

Interventions

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.

MR Imaging on the Alberta linac-MR P3 system

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults ≥ 18 years of age
  • Patients deemed fit to undergo high dose external beam radiation therapy by their attending radiation oncologist

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
  • Patients who are unable to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2020

First Posted

April 24, 2020

Study Start

August 23, 2021

Primary Completion (Estimated)

January 1, 2029

Study Completion (Estimated)

January 1, 2029

Last Updated

May 14, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations