Try the modernized beta website. Learn more about the modernization effort.
Working… Menu

Perfexion Registration Using CBCT

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04170777
Recruitment Status : Recruiting
First Posted : November 20, 2019
Last Update Posted : October 6, 2021
Information provided by (Responsible Party):
University Health Network, Toronto

Brief 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.

Condition or disease
Brain Metastases

Detailed 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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 1250 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Use of Cone-beam Computed Tomography on Gamma Knife Perfexion for Stereotactic Radiosurgery
Actual Study Start Date : September 1, 2020
Estimated Primary Completion Date : October 1, 2022
Estimated Study Completion Date : October 1, 2022

Arm A
The CBCT imaging involved for Arm A is considered part of the study treatment. Pre and post treatment images will be acquired of the patient treated on Perfexion Gamma Knife using the 'Leksell Coordinate Frame'.
Arm B
Arm B will be undergoing standard treatment on Gamma Knife Perfexion for Stereotactic Radiosurgery using the 'relocatable mask'. Patients with lesions that are >3 cm at the largest diameter will be treated with the relocatable mask for which a hypo fractionated approach may be beneficial.

Primary Outcome Measures :
  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 Outcome Measures :
  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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with Brain metastases scheduled to receive SRS treatment.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04170777

Layout table for location contacts
Contact: David Shultz, M.D., Ph.D 416-946-6899

Layout table for location information
Canada, Ontario
University Health Network Recruiting
Toronto, Ontario, Canada, L4W4C2
Contact: David Shultz, MD. PhD.    416-946-4501 ext 6899   
Sponsors and Collaborators
University Health Network, Toronto
Layout table for investigator information
Principal Investigator: David Shultz, M.D., Ph.D University Health Network, Toronto
Layout table for additonal information
Responsible Party: University Health Network, Toronto Identifier: NCT04170777    
Other Study ID Numbers: UHN REB 17-5662
First Posted: November 20, 2019    Key Record Dates
Last Update Posted: October 6, 2021
Last Verified: October 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Health Network, Toronto:
Advanced cancer
Imaging study
Stereotactic Radiosurgery
Cone-beam computed tomography (CBCT)
Additional relevant MeSH terms:
Layout table for MeSH terms
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases