MR Fingerprinting for Vestibular Schwannomas | NCT04851925

Studies
MR Fingerprinting for Vestibular Schwannomas

NCT04851925

Sponsor

Medical University of Vienna

Status

Unknown status

Last Update Posted

Jan 5, 2024Actual

Enrollment

50Estimated

Phase

Not provided

Conditions

Vestibular Schwannoma

Interventions

MR Fingerprinting

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 24, 2021Actual

Primary Completion Date

Dec 24, 2025Estimated

Completion Date

Dec 24, 2025Estimated

First Submitted Date

Apr 15, 2021

First Submission Date that Met QC Criteria

Apr 15, 2021

First Posted Date

Apr 21, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 4, 2024

Last Update Posted Date

Jan 5, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Josa M Frischer, MD, PhD, Principal Investigator, Medical University of ViennaPrincipal Investigator

Lead Sponsor

Medical University of ViennaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MR Fingerprinting	Other	Specific Magnetic Resonance Imaging protocol

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Dorian Hirschmann, MD	Contact	+4314040025780		dorian.hirschmann@meduniwien.ac.at
Josa Frischer, MD	Contact	+4314040045500		josa.frischer@meduniwien.ac.at

Overall Officials

Name	Affiliation	Role
Josa Frischer, MD	Medical University of Vienna	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical University of Vienna	Recruiting	Vienna		1090	Austria

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009464	Neuroma, Acoustic

Ancestor Terms

ID	Term
D009442	Neurilemmoma
D018358	Neuroendocrine Tumors
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal

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Browse Branches

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