- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05413473
Northern Alberta Linac-MR Image-Guided Radiotherapy (Northern LIGHTs-2)
Northern Alberta Linac-MR Image-Guided Human Clinical Trials - 2
Study Overview
Detailed Description
This prospective, open-label, Phase I/II, clinical trial is feasibility study to evaluate MR-guided radiotherapy with the Alberta linac-MR P3 system in adult patients with cancer that are treated with external beam radiotherapy in four graduated stages (described below), progressing from palliative participants with simple techniques to curative participants with complex techniques, with progression to each stage determined by an internal SAFE review committee. Conventional treatment margins and doses will be utilized, with the MR being utilized in place of CT based imaging. The intent is to replicate current CT based treatments on the Alberta linac-MR P3 system using MR guided imaging, planning and treatment delivery. MR imaging will be utilized for simulation, planning and image guidance. Dosimetry will be done as per standard of care. MRI contrast may be used, as applicable. Adverse events will be collected weekly during RT, and participants will complete one questionnaire at the end of their RT treatment. Follow-up will consist of adverse event assessment at 1, 3, 6, and 12 months following completion of RT, and may be assessed annually via chart review for up to 5 years. Survival status will be assessed at 12 months following completion of RT, and then annually for up to 5 years.
In stage 1, 10 to 28 participants with incurable malignancies that require palliative radiotherapy with parallel-opposed pair beam arrangements will be enrolled. These will be patients with bone or brain metastases from their malignancies that require either a single fraction or multiple fractions of radiotherapy. The treatment will be a simple opposed pair beam arrangement to a dose of a single 8 Gy or to a dose of 20 Gy over a course of 5 fractions. Once some initial treatments are completed, and at the discretion of an internal SAFE review committee, additional treatment sites will be permitted (i.e. lung, abdomen, etc.) that are also utilizing a simple opposed pair beam arrangement with the above doses.
In stage 2, 10 to 28 participants with malignancies (curative or palliative treatments) that require multi-field arrangement for their external beam radiotherapy will be enrolled. Initially, 4 field techniques (anterior, posterior, right lateral, left lateral) will be utilized to treat central tumors using fractionation schemes that are currently considered standard of care. Patients with pelvic malignancies (i.e. rectal cancers, cervical cancers, endometrial cancers) or other malignancies requiring simple four field techniques will be identified for this stage. As well, breast patients requiring a simple tangential opposed pair beam arrangement or 3 - 4 field technique (to include the supraclavicular nodal regions) will be enrolled, with preference for standard hypofractionation schedules, if possible.
In stage 3, 10 to 28 participants with malignancies (primarily curable, but incurable malignancies may also be considered) that require more complicated multi-field 3DCRT treatments (not requiring IMRT) for their external beam radiotherapy (i.e. lung, brain, etc.) will be enrolled. This will include the use of field-in-field techniques such as step-and-shoot techniques to allow for modulation of the radiation beam during treatment.
In stage 4, 10 to 28 participants with malignancies (primarily curable, but incurable malignancies may also be considered) that require more complicated multi-field IMRT treatments for their external beam radiotherapy (i.e. prostate, head and neck, lung, brain, etc.) will be enrolled.
Study Type
Enrollment (Estimated)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Contact
- Name: Nawaid Usmani, MD
- Phone Number: 780-432-8518
- Email: Nawaid.Usmani@ahs.ca
Study Locations
-
-
Alberta
-
Edmonton, Alberta, Canada, T6G 1Z2
- Recruiting
- Cross Cancer Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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 and breast treatments (curative or palliative) Stage 3: Radical treatments - multi-field 3DCRT (curative) Stage 4: Radical treatments - multi-field IMRT (curative) |
MR guided radiotherapy using the Alberta linac-MR P3 system
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of participants that complete a course of external beam radiotherapy with the Alberta linac-MR P3 system
Time Frame: Approximately 26 months
|
The total number of participants completing, without clinically unacceptable interruptions, a course of treatment on the Alberta linac-MR P3 system.
The study will track the number of participants that complete treatment without any significant interruptions or delays in their treatment.
|
Approximately 26 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of acute toxicity
Time Frame: 6 months post treatment
|
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.
|
6 months post treatment
|
Incidence of late toxicity
Time Frame: between 6 months and 5 years post treatment
|
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.
|
between 6 months and 5 years post treatment
|
Quantify the patient experience on the Linac-MR
Time Frame: 1 year post treatment
|
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.
|
1 year post treatment
|
Overall treatment time
Time Frame: 1 year post treatment
|
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.
|
1 year post treatment
|
Overall treatment planning time
Time Frame: 1 year post treatment
|
The total treatment planning time using the Linac-MR will be recorded for each participant.
The overall treatment planning time should be within the currently accepted ready to treat timelines for conventional radiotherapy.
|
1 year post treatment
|
Time to local control
Time Frame: Up to 5 years after completion of treatment
|
Time from treatment until the recurrence of disease locally.
|
Up to 5 years after completion of treatment
|
Disease-free survival
Time Frame: Up to 5 years after completion of treatment
|
Time from treatment until the recurrence of disease (or death).
|
Up to 5 years after completion of treatment
|
Overall survival
Time Frame: Up to 5 years after completion of treatment
|
Time from treatment until death from any cause.
Survival status will be assessed at 12 months following completion of treatment, then annually for up to 5 years.
|
Up to 5 years after completion of treatment
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Nawaid Usmani, MD, Cross Cancer Institute, Alberta Health Services
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- IIT-0019
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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