Intrafractional Head Movement During Radiosurgery

Brain Metastases, Adult Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03896555
• Other study ID #: intrafractpos_2019
• Status: Completed
• Start date: November 1, 2014
• Est. completion date: September 1, 2015

Study information

• Verified date: January 2019
• Source: Medical University Innsbruck
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: September 1, 2015
• Est. primary completion date: September 1, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• single intracranial tumour or metastasis

• stereotactic radiation therapy planned

• immobilization with thermoplastic mask

Related Conditions & MeSH terms

• Brain Metastases, Adult

Intervention

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

Locations

Country	Name	City	State
Austria	Medical University Innsbruck	Innsbruck

Sponsors (1)

Lead Sponsor	Collaborator
Medical University Innsbruck

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3D Head deviation	Length of 3D head position deviation during RT session	5 to 20 days