Brain Metastases Clinical Trial
Official title:
Use of Cone-beam Computed Tomography on Gamma Knife Perfexion for Stereotactic Radiosurgery
Verified date | January 2023 |
Source | University Health Network, Toronto |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Measuring precision radiation delivery through cone-beam computed tomography (CBCT) and intra-fraction motion management (IFMM) incorporated on a GammaKnife unit via the Leksell Coordinate Frame (LCF) and relocatable mask system (RMS) immobilization devices.
Status | Completed |
Enrollment | 1250 |
Est. completion date | September 29, 2022 |
Est. primary completion date | September 29, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. At least 18 years old 2. Ability to provide informed consent 3. Any patient receiving single or multi-fraction stereotactic radiosurgery on the Perfexion Gamma Knife with image-guidance Exclusion Criteria: 1. Age < 18 years old. |
Country | Name | City | State |
---|---|---|---|
Canada | University Health Network | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
University Health Network, Toronto |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Setup variation of LCF and relocatable mask using CBCT Imaging | To quantify inter- and intra-fraction setup variations with the Leksell Coordinate Frame (LCF) and relocatable mask device as measured on CBCT and IFMM | Through study completion, an average of 1 week | |
Primary | Setup variation in positioning between CT planning and treatment | Measure intra-fraction setup variations between the CT planning and treatment position for the LCF and relocatable mask device | Through study completion, an average of 1 week | |
Secondary | Target volume margins for brain metastases | To determine evidence-based planning target volume margins for brain metastases patients undergoing treatment with single and multi-fraction stereotactic radiotherapy on the Perfexion™ Gamma Knife unit, as observed on volumetric cone-beam computed tomography (CBCT) scans | Through study completion, an average of 1 week |
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