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OpenTrials
Completed

NCT Number: NCT03896555

Intrafractional Head Movement During Radiosurgery

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University Innsbruck

Innsbruck, 6020, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

ExacTrac position verification

Device

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

Primary outcomes

  1. 3D Head deviation

    Time frame: 5 to 20 days

    Length of 3D head position deviation during RT session

Sponsors and collaborators

Lead sponsor

Medical University Innsbruck

Other

Registry information

Official study title

Intrafractional 6D Head Movement With Mask Fixation During Stereotactic Intracranial RT-sessions

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Apr 1, 2019
Registry last updated
Apr 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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