Intrafractional Head Movement During Radiosurgery

• Sponsor: Medical University Innsbruck (Other)
• Overall Status: Completed
• CT.gov ID: NCT03896555
• Collaborator: (none)
• Enrollment: 5
• Location: 1
• Actual Duration (Months): 10
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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	Phase
Brain Metastases, Adult	Device: ExacTrac position verification

Study Design

• 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: Nov 1, 2014
• Actual Primary Completion Date: Sep 1, 2015
• Actual Study Completion Date: Sep 1, 2015

Outcome Measures

Primary Outcome Measures

1. 3D Head deviation [5 to 20 days]

   Length of 3D head position deviation during RT session

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• single intracranial tumour or metastasis

• stereotactic radiation therapy planned

• immobilization with thermoplastic mask

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical University Innsbruck	Innsbruck		Austria	6020

Sponsors and Collaborators

• Medical University Innsbruck

Investigators

• Principal Investigator: Meinhard Nevinny-Stickel, MD, PhD, Medical University Innsbruck

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jan 25, 2019

More Information

Publications

None provided.

• Responsible Party: Medical University Innsbruck
• ClinicalTrials.gov Identifier: NCT03896555
• Other Study ID Numbers: intrafractpos_2019
• First Posted: Apr 1, 2019
• Last Update Posted: Apr 1, 2019
• Last Verified: Jan 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Brain Neoplasms

Study Results

No Results Posted as of Apr 1, 2019