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CompletedNCT03896555Updated Apr 1, 2019

Intrafractional Head Movement During Radiosurgery

An observational study in Brain Metastases, Adult, sponsored by Medical University Innsbruck. Completed at 1 site in Austria. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-04-01.

Sponsored by Medical University Innsbruck · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
5
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Brain Metastases, Adult

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In context

Brain Neoplasms

1,960 studies on the registry are indexed under Brain Neoplasms; 516 are open to participants now.

This study's enrollment of 5 is below the median of 100 across 380 observational studies indexed under Brain Neoplasms.

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Lead sponsor

Medical University Innsbruck is the lead sponsor of 182 studies on the registry; 49 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Eligibility criteria

Inclusion Criteria:

  • single intracranial tumour or metastasis
  • stereotactic radiation therapy planned
  • immobilization with thermoplastic mask
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
5 participants (actual)
Patient registry
No

Interventions

  • DeviceExacTrac position verification

    Repeated measurement of patient head position with ExacTrac X-ray Monitoring

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What researchers measure

Primary outcomes

  1. 3D Head deviation

    Length of 3D head position deviation during RT session

    Time frame: 5 to 20 days

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Study locations

1 site
  • Medical University Innsbruck
    Innsbruck, 6020, Austria
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References and documents

Publications

  • Mangesius J, Seppi T, Weigel R, Arnold CR, Vasiljevic D, Goebel G, Lukas P, Ganswindt U, Nevinny-Stickel M. Intrafractional 6D head movement increases with time of mask fixation during stereotactic intracranial RT-sessions. Radiat Oncol. 2019 Dec 18;14(1):231. doi: 10.1186/s13014-019-1425-7. PubMed 31852497 ↗

Study documents

  • Protocol and statistical analysis plan · Jan 25, 2019

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — De-identified Datasets of all measured parameters will be made available

Supporting information: Study protocol, Sap, Csr

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 1, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03896555
Lead sponsor
Medical University Innsbruck
Responsible party
Sponsor
First posted
Apr 1, 2019
Start date
Nov 1, 2014
Primary completion
Sep 1, 2015
Completion
Sep 1, 2015
Last update
Apr 1, 2019

Study contacts

Meinhard Nevinny-Stickel, MD, PhD
principal investigator · Medical University Innsbruck

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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