Brain Cancer Clinical Trial
Official title:
MRI-based Immobilization and Planning: A Feasibility Study of a Novel Inverse Method for CNS Radiotherapy
Verified date | October 2022 |
Source | University Health Network, Toronto |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a single site, investigator initiated study that aims to explore the feasibility of using a personalized 3D printed immobilization mask for CNS patients undergoing radiation therapy. For the purpose of this study, patients will undergo the standard CT SIM, and MR SIM necessary for radiation therapy, creating the masks from the MRIs. Prior to the start of their treatment, patients will have an additional CT scan with the 3D printed mask to confirm safety and treatment accuracy. Patients will then proceed with their standard radiation therapy, immobilized with the mask. There will be a control group that will be treated with the standard thermoplastic mask, as a comparison measure. Both groups will complete a mask tolerability questionnaire throughout the course of their treatment to capture the level of discomfort patients may feel with either masks.
Status | Completed |
Enrollment | 40 |
Est. completion date | October 18, 2022 |
Est. primary completion date | October 18, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age >18 years - Patient with high-grade glioma considered for external beam radiotherapy (15 fractions or more) with or without Temozolamide, or patients with brain metastases considered for fractionated LINAC-based external beam radiotherapy (5 fractions or more) as primary or adjuvant treatment. - No contraindications to MRI - No other medical conditions deemed by the PI to make patient ineligible for the study (i.e. claustrophobia, confusion, delirium). Exclusion Criteria: - None |
Country | Name | City | State |
---|---|---|---|
Canada | Princess Margaret Cancer Centre | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
University Health Network, Toronto |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Treatment planning time | Overall treatment planning time: from planning MRI acquisition to first treatment session delivery. | Baseline to week 1 | |
Primary | 3D-mask confection time | 3D-mask confection time during radiation therapy | Baseline to week 1 | |
Primary | Inter- and intra-fraction motion | Inter- and intra-fraction motion during radiation therapy | Baseline to week one | |
Primary | Patient reported adverse events and tolerability of mask | CT-simulation, first and last week of radiation treatment | First scan through to end of radiation treatment, an average 8 weeks | |
Secondary | Gamma values and histograms for MRI-based plans | Gamma values and histograms for MRI-based plans of Planning MRI and Radiation treatment | First scan through to end of radiation treatment, an average 8 weeks |
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