Intrafractional Head Movement During Radiosurgery

NCT ID: NCT03896555

Last Updated: 2019-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

5 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-11-01

Study Completion Date

2015-09-01

Brief Summary

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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.

Detailed Description

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Conditions

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Brain Metastases, Adult

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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ExacTrac position verification

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* single intracranial tumour or metastasis
* stereotactic radiation therapy planned
* immobilization with thermoplastic mask
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University Innsbruck

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Meinhard Nevinny-Stickel, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical University Innsbruck

Locations

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Medical University Innsbruck

Innsbruck, , Austria

Site Status

Countries

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Austria

References

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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.

Reference Type DERIVED
PMID: 31852497 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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intrafractpos_2019

Identifier Type: -

Identifier Source: org_study_id

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