NCT04851925

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 24, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 15, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 21, 2021

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 24, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 24, 2025

Completed
Last Updated

January 5, 2024

Status Verified

January 1, 2024

Enrollment Period

4.8 years

First QC Date

April 15, 2021

Last Update Submit

January 4, 2024

Conditions

Vestibular Schwannoma

Outcome Measures

Primary Outcomes (3)

  • 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

Interventions

MR FingerprintingOTHER

Specific Magnetic Resonance Imaging protocol

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

RECRUITING

MeSH Terms

Conditions

Neuroma, Acoustic

Condition Hierarchy (Ancestors)

NeurilemmomaNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeuromaNerve Sheath NeoplasmsNeoplasms, Nerve TissueCranial Nerve NeoplasmsNervous System NeoplasmsNeoplasms by SitePeripheral Nervous System NeoplasmsVestibulocochlear Nerve DiseasesRetrocochlear DiseasesEar DiseasesOtorhinolaryngologic DiseasesOtorhinolaryngologic NeoplasmsCranial Nerve DiseasesNervous System Diseases

Study Officials

  • Josa Frischer, MD

    Medical University of Vienna

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dorian Hirschmann, MD

CONTACT

+4314040025780dorian.hirschmann@meduniwien.ac.at

Josa Frischer, MD

CONTACT

+4314040045500josa.frischer@meduniwien.ac.at

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 15, 2021

First Posted

April 21, 2021

Study Start

February 24, 2021

Primary Completion

December 24, 2025

Study Completion

December 24, 2025

Last Updated

January 5, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)