HyperArc Registry Study

Recruiting

• Conditions: Brain Metastases; CNS Neoplasm; CNS Disorder, Intracranial

• Registration Number: NCT05270707
• Lead Sponsor: Varian, a Siemens Healthineers Company

Brief Summary

The HyperArc registry is designed to collect data from which the efficacy of the HyperArc procedure can be assessed and compared to alternative treatments.

Detailed Description

A significant percentage of newly diagnosed cancer patients will develop brain metastases. For many of these patients, stereotactic radiosurgery (SRS) is recommended as a primary treatment option. Concerns about complexity, patient safety, cost, and human resources can make SRS challenging. HyperArc radiotherapy addresses these challenges by introducing key technology and workflow elements to streamline multi-leaf collimator-based, non-coplanar SRS. HyperArc is designed to deliver SRS treatments from the TrueBeam linear accelerator platform. The HyperArc registry is designed to collect data from which the efficacy of the HyperArc procedure can be assessed and compared to alternative treatments.

Study Timeline

• Study First Submitted: 2022-02-14
• Study First Submitted QC: 2022-02-25
• Study First Posted: 2022-03-08
• Study Start: 2022-03-31
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-12
• Last Update Posted: 2023-02-14
• Primary Completion: 2031-12-31
• Study Completion: 2031-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5000

Inclusion Criteria

• Received or scheduled to receive treatment using the HyperArc treatment method
• Age of legal adult according to local law
• Signed informed consent form, or, informed consent waived by the local ethics board/institutional review board

Exclusion Criteria

• None, apart from not meeting Inclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Survival	follow until death, on average approximately 2 years	Survival

Secondary Outcome Measures

Name	Time	Method
Local tumor control	follow until death, on average approximately 2 years	Response of treated tumors
HyperArc Patterns of Care	Limited to course of treatment: up to 4 weeks	Dosimetry information for clinically delivered HyperArc treatments

Trial Locations

Locations (5)

University of Alabama; 🇺🇸 Birmingham, Alabama, United States

Icon Cancer Centre Greenslopes; 🇦🇺 Greenslopes, Queensland, Australia

Icon Cancer Centre Maroochydore; 🇦🇺 Maroochydore, Queensland, Australia

Icon Cancer Centre Canberra; 🇦🇺 Bruce, Australian Capital Territory, Australia

Icon Cancer Centre Gold Coast Private; 🇦🇺 Southport, Queensland, Australia