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Clinical Trials/NCT03896555
NCT03896555CompletedNot Applicable

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

Medical University Innsbruck1 site in 1 country5 target enrollmentStarted: November 1, 2014Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
5
Locations
1
Primary Endpoint
3D Head deviation

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

3D Head deviation

Time Frame: 5 to 20 days

Length of 3D head position deviation during RT session

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Medical University Innsbruck
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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