Perfexion Registration Using CBCT

Brain Metastases Clinical Trial

Official title:

Use of Cone-beam Computed Tomography on Gamma Knife Perfexion for Stereotactic Radiosurgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04170777
• Other study ID #: UHN REB 17-5662
• Status: Completed
• Start date: September 1, 2020
• Est. completion date: September 29, 2022

Study information

• Verified date: January 2023
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

: Brain metastases are reported to occur in 20% to 40% of all patients with cancer. Treatment options for brain metastases include surgical resection, particularly in lesions causing significant mass effect, whole brain radiation (WBRT) and radiosurgery (SRS). Due to concerns of neurocognitive toxicity following WBRT, there is growing use of SRS, particularly in patients with limited brain metastases and controlled extracranial disease. Radiosurgery delivers a high dose of radiation to a defined intracranial target through precise targeting with a sharp dose fall off at the target boundaries and minimal damage to surrounding tissue. To date, precision radiation delivery has been facilitated through the Leksell Coordinate Frame (LCF), fixated to the patient's skull through 4 pins. A relocatable mask system (RMS), consisting of a patient specific head rest and mask was developed to enable minimally-invasive fractioned radiosurgery. A cone-beam computed tomography (CBCT) image guidance and intra-fraction motion management (IFMM) system was previously developed in-house in order to measure and address setup uncertainties on Gamma Knife. The in-house prototype has been integrated into a commercially available GammaKnife device with CBCT guidance. The installation of this device will enable volumetric guidance for all patients treated in either a single or multiple session on GammaKnife Perfexion. This study is designed to have 2 arms, A and B. Both Arm A (using the Leksell Coordinate Frame) and Arm B (using the relocatable mask) are undergoing standard of care treatment on GammaKnife Perfexion for SRS. CBCT is part of standard of care for Arm B. However, CBCT imaging is considered as part of study treatment for Arm A. Pre and post treatment images will be acquired of the patient treated on Perfexion Gamma Knife using the Leksell Coordinate Frame in order to aid in analyzing the imaging metrics of the Image Guided Perfexion unit.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Brain Metastases
• Brain Neoplasms

Locations

Country	Name	City	State
Canada	University Health Network	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

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