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Intrafractional Head Movement During Radiosurgery

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03896555
Recruitment Status : Completed
First Posted : April 1, 2019
Last Update Posted : April 1, 2019
Sponsor:
Information provided by (Responsible Party):
Medical University Innsbruck

Brief Summary:

This study investigates the intrafractional accuracy of a frameless thermoplastic mask used for head immobilization during stereotactic radiotherapy. Non-invasive masks cannot completely prohibit head movements. Previous studies attempted to estimate the magnitude of intrafractional inaccuracy by means of pre- and postfractional measurements only. However, this might not be sufficient to accurately map also intrafractional head movements.

Intrafractional deviation of mask-fixed head positions is measured in five patients during a total of 94 fractions by means of close-meshed repeated ExacTrac measurements conducted during the entire treatment session. From the obtained data the investigators evaluate the need to adjust safety margins around the gross tumor volume (GTV) whenever the investigated thermoplastic mask is used instead of invasive ring fixation.


Condition or disease Intervention/treatment
Brain Metastases, Adult Device: ExacTrac position verification

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Study Type : Observational
Actual Enrollment : 5 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Intrafractional 6D Head Movement With Mask Fixation During Stereotactic Intracranial RT-sessions
Actual Study Start Date : November 1, 2014
Actual Primary Completion Date : September 1, 2015
Actual Study Completion Date : September 1, 2015

Intervention Details:
  • Device: ExacTrac position verification
    Repeated measurement of patient head position with ExacTrac X-ray Monitoring


Primary Outcome Measures :
  1. 3D Head deviation [ Time Frame: 5 to 20 days ]
    Length of 3D head position deviation during RT session



Information from the National Library of Medicine

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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
5 Patients with a single intracranial tumour treated with stereotactic radiation therapy
Criteria

Inclusion Criteria:

  • single intracranial tumour or metastasis
  • stereotactic radiation therapy planned
  • immobilization with thermoplastic mask

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): NCT03896555


Locations
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Austria
Medical University Innsbruck
Innsbruck, Austria, 6020
Sponsors and Collaborators
Medical University Innsbruck
Investigators
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Principal Investigator: Meinhard Nevinny-Stickel, MD, PhD Medical University Innsbruck
  Study Documents (Full-Text)

Documents provided by Medical University Innsbruck:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Medical University Innsbruck
ClinicalTrials.gov Identifier: NCT03896555    
Other Study ID Numbers: intrafractpos_2019
First Posted: April 1, 2019    Key Record Dates
Last Update Posted: April 1, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified Datasets of all measured parameters will be made available
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Data will be available after publication
Access Criteria: The datasets used and analysed during the study will be available from the corresponding author on reasonable request

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes