Brain Metastases, AdultNCT03896555
Intrafractional Head Movement During Radiosurgery
An observational study of Brain Metastases, Adult, run by Medical University Innsbruck at 1 site in Austria.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Metastases, Adult
- What is being tested?
- ExacTrac position verification
- Type of treatment
- Medical device
- How many people
- 5 participants
- Where
- 1 siteAustria
- Study dates
- 1 Nov 2014to 1 Sep 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 5 Patients with a single intracranial tumour treated with stereotactic radiation therapy
Who may be able to join
- single intracranial tumour or metastasis
- stereotactic radiation therapy planned
- immobilization with thermoplastic mask
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intrafractional 6D Head Movement With Mask Fixation During Stereotactic Intracranial RT-sessions
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.
- Conditions
- Brain Metastases, Adult
- Being tested
- ExacTrac position verification
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExacTrac position verificationDevice
Repeated measurement of patient head position with ExacTrac X-ray Monitoring
What is being measured
The primary outcome is the main question the study is designed to answer.
3D Head deviation
Length of 3D head position deviation during RT session
Measured: 5 to 20 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2019
- Study start1 Nov 2014
- Primary completion1 Sep 2015
- Study completion1 Sep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Brain Metastases, AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University Innsbruck
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Meinhard Nevinny-Stickel, MD, PhD, Principal investigator, Medical University Innsbruck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03896555
- Sponsor's protocol ID
- intrafractpos_2019
- Status last verified
- Jan 2019
- First submitted
- 28 Mar 2019
- Last updated
- 1 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified Datasets of all measured parameters will be made available
Publications
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.
PubMed 31852497
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intrafractional 6D Head Movement With Mask Fixation During Stereotactic Intracranial RT-sessions
- ClinicalTrials.gov ID
- NCT03896555
- Acronym / sponsor ID
- intrafractpos_2019
- Conditions
- Brain Metastases, Adult
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Medical University InnsbruckUniversity, hospital or other
- Study start
- 1 Nov 2014 (actual)
- Primary completion
- 1 Sep 2015 (actual)
- Study completion
- 1 Sep 2015 (actual)
- First posted
- 1 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 5 Patients with a single intracranial tumour treated with stereotactic radiation therapy
Key inclusion criteria (3 listed)
- single intracranial tumour or metastasis
- stereotactic radiation therapy planned
- immobilization with thermoplastic mask
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExacTrac position verificationRepeated measurement of patient head position with ExacTrac X-ray Monitoring | Device | – |
Primary outcome
3D Head deviation
Time frame: 5 to 20 days
Length of 3D head position deviation during RT session
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2019.
- Derived from this study: PubMed 31852497Mangesius 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.
- Individual participant dataSharing planned: Yes. De-identified Datasets of all measured parameters will be made available
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meinhard Nevinny-Stickel, MD, PhD principal investigator
Medical University Innsbruck
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Metastases, Adult, run by Medical University Innsbruck at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3D Head deviation (time frame: 5 to 20 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03896555, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2019.