HyperArc Registry Study

Brain Metastases Clinical Trial

Official title:

HyperArc Registry Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05270707
• Other study ID #: VAR-2019-01
• Status: Recruiting
• Start date: March 31, 2022
• Est. completion date: December 31, 2031

Study information

• Verified date: February 2023
• Source: Varian, a Siemens Healthineers Company
• Contact: Lawrence MacDonald, PhD
• Phone: 2066129290
• Email: HyperArcRegistry[@]varian.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: December 31, 2031
• Est. primary completion date: December 31, 2031
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Diseases
• Brain Metastases
• Brain Neoplasms
• Central Nervous System Neoplasms
• CNS Neoplasm

Intervention

Radiation:
• Stereotactic radiosurgery
HyperArc is a radiotherapy treatment with a structured workflow to plan and deliver stereotactic radiosurgery (SRS).

Locations

Country	Name	City	State
Australia	Icon Cancer Centre Canberra	Bruce	Australian Capital Territory
Australia	Icon Cancer Centre Greenslopes	Greenslopes	Queensland
Australia	Icon Cancer Centre Maroochydore	Maroochydore	Queensland
Australia	Icon Cancer Centre Gold Coast Private	Southport	Queensland
United States	University of Alabama	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
Varian, a Siemens Healthineers Company

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival	Survival	follow until death, on average approximately 2 years
Secondary	Local tumor control	Response of treated tumors	follow until death, on average approximately 2 years
Secondary	HyperArc Patterns of Care	Dosimetry information for clinically delivered HyperArc treatments	Limited to course of treatment: up to 4 weeks