Brain CancerNCT04114786
3D Printed Mask for GBM and Brain Mets
A study testing 3D-printed mask and Thermoplastic mask in people with Brain Cancer, run by University Health Network, Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Cancer
- What is being tested?
- 3D-printed mask and Thermoplastic mask
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 26 Sep 2019to 18 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: MRI-based Immobilization and Planning: A Feasibility Study of a Novel Inverse Method for CNS Radiotherapy
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.
Read the detailed description
All patients referred for radiotherapy have had a previous diagnostic imaging study (CT-scan or more commonly MRI) showing the disease at the central nervous system (CNS). Moreover, after surgical biopsy or resection, many Centers perform repeated post-operative imaging. Despite all prior imaging, when radiotherapy treatment is decided, all patients undergo another imaging study (CT simulation [CT-sim]) in which patient's head is placed in a reproducible position, and endure a moulding procedure to create a personalized plastic mask for securing the patient's head in a fixed position during the CT acquisition, and reproduced at the subsequent radiation treatment sessions. Typical wait times between moulding, CT-sim and the first radiation treatment is 3-7 days. If a method would be available to accurately recreate the patient's position during diagnostic imaging and reproduce it during radiation treatments without the need for a moulding session or CT-sim, the treatment process can be streamlined and wait times shortened for patients.
Previous studies using 3D printing technology in radiotherapy (such as brachytherapy applicators) have shown that these employed materials are safe for use in clinical settings, and 3D printers can accurately produce devices of various shapes and sizes for clinical use.
In this study, we propose a novel workflow in which patient's position at diagnostic imaging is reproduced with a 3D-printed patient-specific immobilization device, enabling the use of the same diagnostic imaging for planning purposes in lieu of dedicated simulation and moulding sessions, to decrease wait times for patients between diagnostic imaging and start of radiation treatment.
- Conditions
- Brain Cancer
- Being tested
- 3D-printed mask, Thermoplastic mask
- Keywords
- Radiation, Brain Cancer, Glioblastoma, 3D printed mask
- Medical subject headings
- Brain Neoplasms, Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D-printed maskDevice
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
Thermoplastic maskDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 3D-printed mask | Experimental | 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.The group will complete a mask tolerability questionnaire throughout the course of their treatment to capture the level of discomfort patients may feel with either masks. Receives: Device: 3D-printed mask |
| Control group | Active comparator | Control group that will be treated with the standard thermoplastic mask, as a comparison measure. The group will complete a mask tolerability questionnaire throughout the course of their treatment to capture the level of discomfort patients may feel with either masks. Receives: Device: Thermoplastic mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment planning time
Overall treatment planning time: from planning MRI acquisition to first treatment session delivery.
Measured: Baseline to week 1
3D-mask confection time
3D-mask confection time during radiation therapy
Measured: Baseline to week 1
Inter- and intra-fraction motion
Inter- and intra-fraction motion during radiation therapy
Measured: Baseline to week one
Patient reported adverse events and tolerability of mask
CT-simulation, first and last week of radiation treatment
Measured: First scan through to end of radiation treatment, an average 8 weeks
Secondary outcomes (1)
Gamma values and histograms for MRI-based plans
Gamma values and histograms for MRI-based plans of Planning MRI and Radiation treatment
Measured: First scan through to end of radiation treatment, an average 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2019
- Study start26 Sep 2019
- Primary completion18 Oct 2022
- Study completion18 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain CancerStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alejandro Berlin, <D, Principal investigator, Princess Margaret
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04114786
- Sponsor's protocol ID
- 18-5753
- Status last verified
- Oct 2022
- First submitted
- 25 Jul 2019
- Last updated
- 21 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MRI-based Immobilization and Planning: A Feasibility Study of a Novel Inverse Method for CNS Radiotherapy
- ClinicalTrials.gov ID
- NCT04114786
- Acronym / sponsor ID
- 18-5753
- Conditions
- Brain Cancer
- Keywords
- Radiation, Brain Cancer, Glioblastoma, 3D printed mask
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 26 Sep 2019 (actual)
- Primary completion
- 18 Oct 2022 (actual)
- Study completion
- 18 Oct 2022 (actual)
- First posted
- 3 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
All patients referred for radiotherapy have had a previous diagnostic imaging study (CT-scan or more commonly MRI) showing the disease at the central nervous system (CNS). Moreover, after surgical biopsy or resection, many Centers perform repeated post-operative imaging. Despite all prior imaging, when radiotherapy treatment is decided, all patients undergo another imaging study (CT simulation [CT-sim]) in which patient's head is placed in a reproducible position, and endure a moulding procedure to create a personalized plastic mask for securing the patient's head in a fixed position during the CT acquisition, and reproduced at the subsequent radiation treatment sessions. Typical wait times between moulding, CT-sim and the first radiation treatment is 3-7 days. If a method would be available to accurately recreate the patient's position during diagnostic imaging and reproduce it during radiation treatments without the need for a moulding session or CT-sim, the treatment process can be streamlined and wait times shortened for patients.
Previous studies using 3D printing technology in radiotherapy (such as brachytherapy applicators) have shown that these employed materials are safe for use in clinical settings, and 3D printers can accurately produce devices of various shapes and sizes for clinical use.
In this study, we propose a novel workflow in which patient's position at diagnostic imaging is reproduced with a 3D-printed patient-specific immobilization device, enabling the use of the same diagnostic imaging for planning purposes in lieu of dedicated simulation and moulding sessions, to decrease wait times for patients between diagnostic imaging and start of radiation treatment.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3D-printed mask | Experimental | Device: 3D-printed maskPatients 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.The group will complete a mask tolerability questionnaire throughout the course of their treatment to capture the level of discomfort patients may feel with either masks. |
| Control group | Active comparator | Device: Thermoplastic maskControl group that will be treated with the standard thermoplastic mask, as a comparison measure. The group will complete a mask tolerability questionnaire throughout the course of their treatment to capture the level of discomfort patients may feel with either masks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3D-printed maskAfter 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 | 3D-printed mask |
| Thermoplastic maskPatients 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. | Device | Control group |
Primary outcome
Treatment planning time
Time frame: Baseline to week 1
Overall treatment planning time: from planning MRI acquisition to first treatment session delivery.
3D-mask confection time
Time frame: Baseline to week 1
3D-mask confection time during radiation therapy
Inter- and intra-fraction motion
Time frame: Baseline to week one
Inter- and intra-fraction motion during radiation therapy
Patient reported adverse events and tolerability of mask
Time frame: First scan through to end of radiation treatment, an average 8 weeks
CT-simulation, first and last week of radiation treatment
1 secondary outcome
Gamma values and histograms for MRI-based plans
Time frame: First scan through to end of radiation treatment, an average 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alejandro Berlin, <D principal investigator
Princess Margaret
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D-printed mask and Thermoplastic mask in people with Brain Cancer, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment planning time (time frame: Baseline to week 1). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2022.