Brain MetastasesNCT05270707
HyperArc Registry Study
An observational study of Brain Metastases and CNS Neoplasm, run by Varian, a Siemens Healthineers Company at 7 sites in 4 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Metastases, CNS Neoplasm, CNS Disorder, Intracranial
- What is being tested?
- Stereotactic radiosurgery
- Type of treatment
- Surgery or procedure
- How many people
- 968 participants
- Where
- 7 sitesin 4 countries
- Study dates
- 31 Mar 2022to 31 Mar 2025
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Any patient scheduled to be treated using the HyperArc method will be invited to participate, provided they meet other eligibility criteria.
Who may be able to join
- 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
Who cannot join
- None, apart from not meeting Inclusion Criteria
Trial locations and contacts
7 sites in 4 countries.
7 sites in 4 countries
Australia4 sites
Icon Cancer Centre Canberra
Bruce, Australian Capital Territory, 2617
Icon Cancer Centre Greenslopes
Greenslopes, Queensland, 4120
Icon Cancer Centre Maroochydore
Maroochydore, Queensland, 4558
Icon Cancer Centre Gold Coast Private
Southport, Queensland, 4215
Italy1 site
L'IRCCS Ospedale Sacro Cuore - Don Calabria
Negrar, Valpolicella, 37024
About this study
The HyperArc registry is designed to collect data from which the efficacy of the HyperArc procedure can be assessed and compared to alternative treatments.
Read the 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.
- Conditions
- Brain Metastases, CNS Neoplasm, CNS Disorder, Intracranial
- Being tested
- Stereotactic radiosurgery
- Keywords
- Stereotactic Radiosurgery
- Medical subject headings
- Brain Neoplasms, Central Nervous System Neoplasms, Brain Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic radiosurgeryRadiation
Also called HyperArc SRS
HyperArc is a radiotherapy treatment with a structured workflow to plan and deliver stereotactic radiosurgery (SRS).
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Survival
Measured: follow until death, on average approximately 2 years
Secondary outcomes (2)
Local tumor control
Response of treated tumors
Measured: follow until death, on average approximately 2 years
HyperArc Patterns of Care
Dosimetry information for clinically delivered HyperArc treatments
Measured: Limited to course of treatment: up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2022
- Study start31 Mar 2022
- Primary completion31 Mar 2025
- Study completion31 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain MetastasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 968 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Varian, a Siemens Healthineers Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05270707
- Sponsor's protocol ID
- VAR-2019-01
- Status last verified
- Sep 2025
- First submitted
- 14 Feb 2022
- Last updated
- 24 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HyperArc Registry Study
- ClinicalTrials.gov ID
- NCT05270707
- Acronym / sponsor ID
- VAR-2019-01
- Conditions
- Brain Metastases, CNS Neoplasm, CNS Disorder, Intracranial
- Keywords
- Stereotactic Radiosurgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 968 participants (actual)
- Lead sponsor
- Varian, a Siemens Healthineers CompanyIndustry (pharma, biotech, devices)
- Study start
- 31 Mar 2022 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 8 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Other
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any patient scheduled to be treated using the HyperArc method will be invited to participate, provided they meet other eligibility criteria.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- None, apart from not meeting Inclusion Criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stereotactic radiosurgeryAlso: HyperArc SRSHyperArc is a radiotherapy treatment with a structured workflow to plan and deliver stereotactic radiosurgery (SRS). | Radiation | – |
Primary outcome
Survival
Time frame: follow until death, on average approximately 2 years
Survival
2 secondary outcomes
Local tumor control
Time frame: follow until death, on average approximately 2 years
HyperArc Patterns of Care
Time frame: Limited to course of treatment: up to 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Metastases and CNS Neoplasm, run by Varian, a Siemens Healthineers Company at 7 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Australia, United States, Belgium, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival (time frame: follow until death, on average approximately 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2025.