Perfexion Registration Using CBCT

NCT04170777 | Completed

• 1 other identifier: UHN REB 17-5662
• Study Type: observational
• Target: 1,250
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Metastases

Keywords

Advanced cancer; Imaging study; Stereotactic Radiosurgery; GammaKnife; Cone-beam computed tomography (CBCT)

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Target volume margins for brain metastases

  Through study completion, an average of 1 week

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Brain metastases scheduled to receive SRS treatment.

You may qualify if:

• 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

You may not qualify if:

• \. Age \< 18 years old.

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

University Health Network

Toronto, Ontario, L4W4C2, Canada

Location

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• David Shultz, M.D., Ph.D

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2019
• First Posted: November 20, 2019
• Study Start: September 1, 2020
• Primary Completion: September 29, 2022
• Study Completion: September 29, 2022
• Last Updated: January 26, 2023

Record last verified: 2023-01

Locations

CA (1)