Perfexion Registration Using CBCT

January 25, 2023 updated by: University Health Network, Toronto

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

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

1250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, L4W4C2
        • University Health Network

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with Brain metastases scheduled to receive SRS treatment.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Through study completion, an average of 1 week
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
Through study completion, an average of 1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Through study completion, an average of 1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Investigators

  • Principal Investigator: David Shultz, M.D., Ph.D, University Health Network, Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2020

Primary Completion (Actual)

September 29, 2022

Study Completion (Actual)

September 29, 2022

Study Registration Dates

First Submitted

November 12, 2019

First Submitted That Met QC Criteria

November 18, 2019

First Posted (Actual)

November 20, 2019

Study Record Updates

Last Update Posted (Estimate)

January 26, 2023

Last Update Submitted That Met QC Criteria

January 25, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UHN REB 17-5662

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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