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3D Printed Mask for GBM and Brain Mets

NCT04114786 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2022-10-21

No results posted yet for this study

Summary

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.

Conditions

Interventions

DEVICE

3D-printed mask

After patient is enrolled to the study, patients will have CT Sim. MR Sim (used to create 3D printed mask for intervention arm only) CT sim repeat (for intervention arm only) before start of radiation Patients will be asked to fill out a questionnaire after each CT Scan, and during the first and last week of radiation treatment

DEVICE

Thermoplastic mask

Patients will undergo standard of care simulation, planning and treatment with conventional workflow using thermoplastic mask.They will complete the tolerability questionnaire after CT-sim, and towards the end of the first and last week of treatment.

Sponsors & Collaborators

  • University Health Network, Toronto

    lead OTHER

Principal Investigators

  • Alejandro Berlin, <D · Princess Margaret

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-26
Primary Completion
2022-10-18
Completion
2022-10-18

Countries

  • Canada

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04114786 on ClinicalTrials.gov