MR Fingerprinting for Vestibular Schwannomas

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.

Study Overview

• Status: Recruiting
• Conditions: Vestibular Schwannoma
• Intervention / Treatment: Other: MR Fingerprinting

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Dorian Hirschmann, MD; Phone Number: +4314040025780; Email: dorian.hirschmann@meduniwien.ac.at
• Study Contact Backup: Name: Josa Frischer, MD; Phone Number: +4314040045500; Email: josa.frischer@meduniwien.ac.at

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Recruiting
    • Medical University of Vienna
    • Contact: Dorian Hirschmann, MD; Phone Number: +4314040025780; Email: dorian.hirschmann@meduniwien.ac.at
    • Sub-Investigator: Dorian Hirschmann, MD
    • Contact: Josa Frischer, MD; Phone Number: +4314040045500; Email: josa.frischer@meduniwien.ac.at
    • Principal Investigator: Josa M Frischer, MD
    • Sub-Investigator: Gilbert Hangel, DI
    • Sub-Investigator: Brigitte Gatterbauer, MD
    • Sub-Investigator: Anna Cho, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

Patients with vestibular schwannoma of minimum 1cm, who will undergo Gamma Knife radiosurgery

Description

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

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Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tumor control	Number of patients without further growth of the tumor on follow-up MRI after radiosurgery	3 years
Tumor growth	Number of patients with growth of the tumor on follow-up MRI after radiosurgery	3 years
Cystic transformation	Number of patients with cystic transformation of the tumor on follow-up MRI after radiosurgery	3 years

Collaborators and Investigators

• Sponsor: Medical University of Vienna
• Investigators: Principal Investigator: Josa Frischer, MD, Medical University of Vienna

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2021
• Primary Completion (Estimated): December 24, 2025
• Study Completion (Estimated): December 24, 2025

Study Registration Dates

• First Submitted: April 15, 2021
• First Submitted That Met QC Criteria: April 15, 2021
• First Posted (Actual): April 21, 2021

Study Record Updates

• Last Update Posted (Actual): January 5, 2024
• Last Update Submitted That Met QC Criteria: January 4, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Otorhinolaryngologic Neoplasms; Otorhinolaryngologic Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Ear Diseases; Nervous System Neoplasms; Cranial Nerve Diseases; Neuroendocrine Tumors; Nerve Sheath Neoplasms; Peripheral Nervous System Neoplasms; Cranial Nerve Neoplasms; Neuroma; Vestibulocochlear Nerve Diseases; Retrocochlear Diseases; Neurilemmoma; Neuroma, Acoustic
• Other Study ID Numbers: EK2451/2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No