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HyperArc Registry Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05270707
Recruitment Status : Recruiting
First Posted : March 8, 2022
Last Update Posted : July 14, 2022
Sponsor:
Information provided by (Responsible Party):
Varian, a Siemens Healthineers Company

Study Description
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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.

Condition or disease Intervention/treatment
Brain Metastases CNS Neoplasm CNS Disorder, Intracranial Radiation: Stereotactic radiosurgery

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
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 5000 participants
Observational Model: Case-Only
Time Perspective: Other
Target Follow-Up Duration: 5 Years
Official Title: HyperArc Registry Study
Actual Study Start Date : March 31, 2022
Estimated Primary Completion Date : December 31, 2031
Estimated Study Completion Date : December 31, 2031
Groups and Cohorts
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Intervention Details:
  • Radiation: Stereotactic radiosurgery
    HyperArc is a radiotherapy treatment with a structured workflow to plan and deliver stereotactic radiosurgery (SRS).
    Other Name: HyperArc SRS

Outcome Measures
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Primary Outcome Measures :
  1. Survival [ Time Frame: follow until death, on average approximately 2 years ]
    Survival


Secondary Outcome Measures :
  1. Local tumor control [ Time Frame: follow until death, on average approximately 2 years ]
    Response of treated tumors

  2. HyperArc Patterns of Care [ Time Frame: Limited to course of treatment: up to 4 weeks ]
    Dosimetry information for clinically delivered HyperArc treatments


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05270707


Contacts
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Contact: Lawrence MacDonald, PhD 2066129290 HyperArcRegistry@varian.com

Locations
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United States, Alabama
University of Alabama Recruiting
Birmingham, Alabama, United States, 35233
Contact: Cindy Perdue    205-996-6147    cperdue@uabmc.edu   
Contact: Tiffany Williams    205-996-3883    tiffanywilliams@uabmc.edu   
Principal Investigator: John B Fiveash, M.D.         
Australia, Australian Capital Territory
Icon Cancer Centre Canberra Not yet recruiting
Bruce, Australian Capital Territory, Australia, 2617
Contact: Mel Grand    +61 437 067 494    research.iit@icon.team   
Principal Investigator: Andrew Lee, MBBS         
Australia, Queensland
Icon Cancer Centre Greenslopes Not yet recruiting
Greenslopes, Queensland, Australia, 4120
Contact: Mel Grand    +61 437 067 494    research.iit@icon.team   
Principal Investigator: Matthew Foote, MBBS         
Icon Cancer Centre Maroochydore Not yet recruiting
Maroochydore, Queensland, Australia, 4558
Contact: Mel Grand    +61 437 067 494    research.iit@icon.team   
Principal Investigator: Joanne D Castelli, MBBS         
Icon Cancer Centre Gold Coast Private Not yet recruiting
Southport, Queensland, Australia, 4215
Contact: Mel Grand    +61 437 067 494    research.iit@icon.team   
Principal Investigator: James E Jackson, MBBS         
Sponsors and Collaborators
Varian, a Siemens Healthineers Company
More Information
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Responsible Party: Varian, a Siemens Healthineers Company
ClinicalTrials.gov Identifier: NCT05270707    
Other Study ID Numbers: VAR-2019-01
First Posted: March 8, 2022    Key Record Dates
Last Update Posted: July 14, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Varian, a Siemens Healthineers Company:
Stereotactic Radiosurgery
Additional relevant MeSH terms:
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Brain Neoplasms
Central Nervous System Neoplasms
Brain Diseases
Neoplasms
 Nervous System Neoplasms
Neoplasms by Site
Central Nervous System Diseases
Nervous System Diseases