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Completed

NCT Number: NCT04170777

Perfexion Registration Using CBCT

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.

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Key information

Conditions

Brain Metastases Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Health Network

Toronto, Ontario, L4W4C2, Canada

About this study

: 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • At least 18 years old
  • Ability to provide informed consent
  • Any patient receiving single or multi-fraction stereotactic radiosurgery on the Perfexion Gamma Knife with image-guidance

Exclusion criteria

  • Age < 18 years old.

Treatment and study plan

Primary outcomes

  1. Setup variation of LCF and relocatable mask using CBCT Imaging

    Time frame: Through study completion, an average of 1 week

    To quantify inter- and intra-fraction setup variations with the Leksell Coordinate Frame (LCF) and relocatable mask device as measured on CBCT and IFMM

  2. Setup variation in positioning between CT planning and treatment

    Time frame: Through study completion, an average of 1 week

    Measure intra-fraction setup variations between the CT planning and treatment position for the LCF and relocatable mask device

Secondary outcomes

  1. Target volume margins for brain metastases

    Time frame: Through study completion, an average of 1 week

    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

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Nov 20, 2019
Registry last updated
Jan 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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