Clinical Trials Logo

Clinical 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. 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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT04114786
Study type Interventional
Source University Health Network, Toronto
Contact
Status Completed
Phase N/A
Start date September 26, 2019
Completion date October 18, 2022

See also
  Status Clinical Trial Phase
Recruiting NCT05023434 - A Study to Measure the Effect of Brain Stimulation on Hand Strength and Function in Patients With Brain Tumors
Terminated NCT01902771 - Dendritic Cell Vaccine Therapy With In Situ Maturation in Pediatric Brain Tumors Phase 1
Recruiting NCT04367779 - Research of Biomarkers of Response to Proton Beam Therapy in Pediatric and Adult Patients.
Recruiting NCT06058988 - Trastuzumab Deruxtecan (T-DXd) for People With Brain Cancer Phase 2
Completed NCT02852655 - A Pilot Surgical Trial To Evaluate Early Immunologic Pharmacodynamic Parameters For The PD-1 Checkpoint Inhibitor, Pembrolizumab (MK-3475), In Patients With Surgically Accessible Recurrent/Progressive Glioblastoma Phase 1
Completed NCT02911155 - Cancer and Other Disease Risks in U.S. Nuclear Medicine Technologists
Completed NCT01650922 - Molecular Genetic Studies of Childhood Brain Tumors and Blood Samples N/A
Completed NCT00329589 - A Trial Using Velcade Plus Chemoradiation for Central Nervous System, Head and Neck, and Cervical Cancer Patients Phase 1
Completed NCT00505141 - Urban Environmental Exposures and Childhood Cancer N/A
Completed NCT00504660 - 6-TG, Capecitabine and Celecoxib Plus TMZ or CCNU for Anaplastic Glioma Patients Phase 2
Completed NCT00979810 - Image-Guided Stereotactic Biopsy of High Grade Gliomas N/A
Recruiting NCT04899908 - Stereotactic Brain-directed Radiation With or Without Aguix Gadolinium-Based Nanoparticles in Brain Metastases Phase 2
Active, not recruiting NCT02851706 - Natural History of and Specimen Banking for People With Tumors of the Central Nervous System
Completed NCT02798406 - Combination Adenovirus + Pembrolizumab to Trigger Immune Virus Effects Phase 2
Completed NCT01012609 - External Beam Radiation Therapy and Cetuximab Followed by Irinotecan and Cetuximab for Children and Young Adults With Newly Diagnosed Diffuse Pontine Tumors and High-Grade Astrocytomas Phase 2
Completed NCT00782756 - Bevacizumab, Temozolomide and Hypofractionated Radiotherapy for Patients With Newly Diagnosed Malignant Glioma Phase 2
Terminated NCT03149575 - VAL-083 Phase 3 Study in Temozolomide-Avastin (Bevacizumab) Recurrent GBM Phase 3
Completed NCT01974804 - Assessment of Early Treatment Response by Diffusion and Perfusion MRI in Patients With Brain Metastasis
Withdrawn NCT01320787 - 18-F-Fluoroacetate as PET Imaging Agent Phase 1
Completed NCT01478178 - Safety Study of VAL-083 in Patients With Recurrent Malignant Glioma Phase 1/Phase 2