HyperArc Registry Study

September 19, 2025 updated by: Varian, a Siemens Healthineers Company
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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

968

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

  • Australia
    • Australian Capital Territory
      • Bruce, Australian Capital Territory, Australia, 2617
        • Icon Cancer Centre Canberra
    • Queensland
      • Greenslopes, Queensland, Australia, 4120
        • Icon Cancer Centre Greenslopes
      • Maroochydore, Queensland, Australia, 4558
        • Icon Cancer Centre Maroochydore
      • Southport, Queensland, Australia, 4215
        • Icon Cancer Centre Gold Coast Private
  • Belgium
      • Leuven, Belgium, 3000
        • University Hospital Leuven
  • Italy
    • Valpolicella
      • Negrar, Valpolicella, Italy, 37024
        • L'IRCCS Ospedale Sacro Cuore - Don Calabria
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • University of Alabama

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

Sampling Method

Non-Probability Sample

Study Population

Any patient scheduled to be treated using the HyperArc method will be invited to participate, provided they meet other eligibility criteria.

Description

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 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-Only
  • Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival
Time Frame: follow until death, on average approximately 2 years
Survival
follow until death, on average approximately 2 years

Secondary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

Varian, a Siemens Healthineers Company

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)

March 31, 2022

Primary Completion (Actual)

March 31, 2025

Study Completion (Actual)

March 31, 2025

Study Registration Dates

First Submitted

February 14, 2022

First Submitted That Met QC Criteria

February 25, 2022

First Posted (Actual)

March 8, 2022

Study Record Updates

Last Update Posted (Estimated)

September 24, 2025

Last Update Submitted That Met QC Criteria

September 19, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VAR-2019-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

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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