Vestibular SchwannomaNCT04851925
MR Fingerprinting for Vestibular Schwannomas
An observational study of Vestibular Schwannoma, run by Medical University of Vienna at 1 site in Austria.
Trial summary
MR Fingerprinting (MRF) will be performed in patients who will be treated with Gamma Knife radio surgery for a vestibular schwannoma before the intervention. Fifty patients will be included with a vestibular schwannoma of minimum 1cm in size. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Vestibular Schwannoma
- What is being tested?
- MR Fingerprinting
- How many people
- 50 participants
- Where
- 1 siteAustria
- Study dates
- 24 Feb 2021to 24 Dec 2025
- 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 to 90 years
- All sexes
- Adult, Older adult
Study population: Patients with vestibular schwannoma of minimum 1cm, who will undergo Gamma Knife radiosurgery
Inclusion Criteria: Planned Gamma Knife radiosurgery for vestibular schwannoma of minimum 1cm in size -
Exclusion Criteria: Vestibular Schwannoma of less than 1cm in size. Other a priori treatment than Gamma Knife radiosurgery
-
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Medical University of Vienna
Vienna, 1090
Josa Frischer, MD, +4314040045500, josa.frischer@meduniwien.ac.at
Dorian Hirschmann, MD, +4314040025780, dorian.hirschmann@meduniwien.ac.at
About this study
Official title: MR-Fingerprinting for the Prediction of the Response of Vestibular Schwannomas to Gamma Knife Radiosurgery
MR Fingerprinting (MRF) will be performed in patients who will be treated with Gamma Knife radio surgery for a vestibular schwannoma before the intervention. Fifty patients will be included with a vestibular schwannoma of minimum 1cm in size. During follow-up, response of the tumor to radiosurgery will be evaluated for each patient with MRI. The aim of the study is to find patterns of vestibular schwannomas in MRF data which correlate with the type of response to radio surgery, i.e. tumor control after radiosurgery, further tumor growth despite radiosurgery, cystic transformation after radiosurgery.
- Conditions
- Vestibular Schwannoma
- Being tested
- MR Fingerprinting
- Medical subject headings
- Neuroma, Acoustic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MR FingerprintingOther
Specific Magnetic Resonance Imaging protocol
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor control
Number of patients without further growth of the tumor on follow-up MRI after radiosurgery
Measured: 3 years
Tumor growth
Number of patients with growth of the tumor on follow-up MRI after radiosurgery
Measured: 3 years
Cystic transformation
Number of patients with cystic transformation of the tumor on follow-up MRI after radiosurgery
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2021
- Study start24 Feb 2021
- Primary completion24 Dec 2025 (estimated)
- Study completion24 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vestibular SchwannomaStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Josa M Frischer, MD, PhD, Medical University of Vienna
- Investigators
- Josa Frischer, MD, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04851925
- Sponsor's protocol ID
- EK2451/2020
- Status last verified
- Jan 2024
- First submitted
- 15 Apr 2021
- Last updated
- 5 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MR-Fingerprinting for the Prediction of the Response of Vestibular Schwannomas to Gamma Knife Radiosurgery
- ClinicalTrials.gov ID
- NCT04851925
- Acronym / sponsor ID
- EK2451/2020
- Conditions
- Vestibular Schwannoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 24 Feb 2021 (actual)
- Primary completion
- 24 Dec 2025 (estimated)
- Study completion
- 24 Dec 2025 (estimated)
- First posted
- 21 Apr 2021 (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.
MR Fingerprinting (MRF) will be performed in patients who will be treated with Gamma Knife radio surgery for a vestibular schwannoma before the intervention. Fifty patients will be included with a vestibular schwannoma of minimum 1cm in size. During follow-up, response of the tumor to radiosurgery will be evaluated for each patient with MRI. The aim of the study is to find patterns of vestibular schwannomas in MRF data which correlate with the type of response to radio surgery, i.e. tumor control after radiosurgery, further tumor growth despite radiosurgery, cystic transformation after radiosurgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with vestibular schwannoma of minimum 1cm, who will undergo Gamma Knife radiosurgery
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 |
|---|---|---|
| MR FingerprintingSpecific Magnetic Resonance Imaging protocol | Other | – |
Primary outcome
Tumor control
Time frame: 3 years
Number of patients without further growth of the tumor on follow-up MRI after radiosurgery
Tumor growth
Time frame: 3 years
Number of patients with growth of the tumor on follow-up MRI after radiosurgery
Cystic transformation
Time frame: 3 years
Number of patients with cystic transformation of the tumor on follow-up MRI after radiosurgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
- Individual participant dataSharing planned: No
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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.
Josa Frischer, MD principal investigator
Medical University of Vienna
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 Vestibular Schwannoma, run by Medical University of Vienna 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?
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: status not confirmed, as of the sponsor's last update on 5 Jan 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dorian Hirschmann, MD (+4314040025780, dorian.hirschmann@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor control (time frame: 3 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jan 2024.