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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04851925
Other study ID # EK2451/2020
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 24, 2021
Est. completion date December 24, 2025

Study information

Verified date January 2024
Source Medical University of Vienna
Contact Dorian Hirschmann, MD
Phone +4314040025780
Email dorian.hirschmann@meduniwien.ac.at
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date December 24, 2025
Est. primary completion date December 24, 2025
Accepts healthy volunteers
Gender All
Age group 18 Years to 90 Years
Eligibility 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 -

Study Design


Related Conditions & MeSH terms


Intervention

Other:
MR Fingerprinting
Specific Magnetic Resonance Imaging protocol

Locations

Country Name City State
Austria Medical University of Vienna Vienna

Sponsors (1)

Lead Sponsor Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type Measure Description Time frame Safety issue
Primary Tumor control Number of patients without further growth of the tumor on follow-up MRI after radiosurgery 3 years
Primary Tumor growth Number of patients with growth of the tumor on follow-up MRI after radiosurgery 3 years
Primary Cystic transformation Number of patients with cystic transformation of the tumor on follow-up MRI after radiosurgery 3 years
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