Response Prediction After GKS in Patients With Vestibular Schwannoma Using DCE MR Imaging

Vestibular Schwannoma Clinical Trial

Official title:

Response Prediction After Gamma Knife Surgery (GKS) in Patients With Vestibular Schwannoma Using Dynamic Contrast-Enhanced (DCE) MR Imaging

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03097822
• Other study ID #: H-1611-087-809
• Status: Not yet recruiting
• Phase: N/A
• First received: March 20, 2017
• Last updated: March 27, 2017
• Start date: January 2017

Study information

• Verified date: March 2017
• Source: Seoul National University Hospital
• Contact: SeungHong Choi, MD,PhD
• Email: verocay[@]snuh.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

The purpose of this study was to evaluate the response of Gamma Knife Surgery to Ktrans, Ve, and Vp, which are indicators of permeability map obtained from dynamic contrast enhanced (DCE) MRI in patients with vestibular schwannoma .

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

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

• Patients with vestibular schwannoma, who received consent

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Neurilemmoma
• Neuroma, Acoustic
• Vestibular Schwannoma

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumor size change before and after surgery		pre-op, Immediately after surgery
Secondary	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