Intrafractional Head Movement During Radiosurgery | NCT03896555

Studies
Intrafractional Head Movement During Radiosurgery

NCT03896555

Sponsor

Medical University Innsbruck

Status

Completed

Last Update Posted

Apr 1, 2019Actual

Enrollment

5Actual

Phase

Not provided

Conditions

Brain Metastases, Adult

Interventions

ExacTrac position verification

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2014Actual

Primary Completion Date

Sep 1, 2015Actual

Completion Date

Sep 1, 2015Actual

First Submitted Date

Mar 28, 2019

First Submission Date that Met QC Criteria

Mar 29, 2019

First Posted Date

Apr 1, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 29, 2019

Last Update Posted Date

Apr 1, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

5Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ExacTrac position verification	Device	Repeated measurement of patient head position with ExacTrac X-ray Monitoring

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
3D Head deviation	Length of 3D head position deviation during RT session	5 to 20 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

5 Patients with a single intracranial tumour treated with stereotactic radiation therapy

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Meinhard Nevinny-Stickel, MD, PhD	Medical University Innsbruck	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical University Innsbruck		Innsbruck		6020	Austria

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
31852497	Derived	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.

ID	Term
D016543	Central Nervous System Neoplasms
D009423	Nervous System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms