NCT03097822

Brief Summary

Response Prediction after Gamma Knife Surgery (GKS) in Patients with Vestibular Schwannoma using Dynamic Contrast-Enhanced (DCE) MR Imaging

Trial Health

50
Monitor

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 20, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 31, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Last Updated

March 31, 2017

Status Verified

March 1, 2017

Enrollment Period

1.9 years

First QC Date

March 20, 2017

Last Update Submit

March 27, 2017

Conditions

Vestibular Schwannoma

Outcome Measures

Primary Outcomes (1)

  • Tumor size change before and after surgery

    pre-op, Immediately after surgery

Secondary Outcomes (1)

  • In patients who underwent gamma knife surgery, the magnitude of tumor size change before and after surgery

    through study completion, an average of 1 year

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with vestibular schwannoma, who underwent gamma knife surgery

You may qualify if:

  • Patients with vestibular schwannoma, who underwent gamma knife surgery and pre-op dynamic contrast enhanced (DCE) MRI
  • Patients with vestibular schwannoma, who received consent

You may not qualify if:

  • In addition to the vestibular schwannoma, if the brain has other underlying or systemic disease
  • During the observation period, other treatments were performed other than gamma knife surgery
  • If patients have a contraindication to MRI (eg, pacemaker, cochlear implants, hemodynamically unstable)
  • Concomitant use of gadolinium MRI contrast agents (eg, renal insufficiency \[glomerular filtration rate \<30 ML / min\]), or if there was a side effect when using a contrast medium.
  • Adults with impaired ability to cope
  • If the images and medical records required for this study are not available or are not appropriate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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

  • SeungHong Choi, MD,PhD

    Seoul National University Hospital(Radiology)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

SeungHong Choi, MD,PhD

CONTACT

verocay@snuh.org

Study Design

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

Study Record Dates

First Submitted

March 20, 2017

First Posted

March 31, 2017

Study Start

January 1, 2017

Primary Completion

December 1, 2018

Last Updated

March 31, 2017

Record last verified: 2017-03