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

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ClinicalTrials.gov Identifier: NCT03097822
Recruitment Status : Unknown
Verified March 2017 by Seung Hong Choi, Seoul National University Hospital.
Recruitment status was:  Not yet recruiting
First Posted : March 31, 2017
Last Update Posted : March 31, 2017
Sponsor:
Information provided by (Responsible Party):
Seung Hong Choi, Seoul National University Hospital

Tracking Information
First Submitted Date March 20, 2017
First Posted Date March 31, 2017
Last Update Posted Date March 31, 2017
Study Start Date January 2017
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 27, 2017)
Tumor size change before and after surgery [ Time Frame: pre-op, Immediately after surgery ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: March 27, 2017)
In patients who underwent gamma knife surgery, the magnitude of tumor size change before and after surgery [ Time Frame: through study completion, an average of 1 year ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Response Prediction After GKS in Patients With Vestibular Schwannoma Using DCE MR Imaging
Official Title Response Prediction After Gamma Knife Surgery (GKS) in Patients With Vestibular Schwannoma Using Dynamic Contrast-Enhanced (DCE) MR Imaging
Brief Summary Response Prediction after Gamma Knife Surgery (GKS) in Patients with Vestibular Schwannoma using Dynamic Contrast-Enhanced (DCE) MR Imaging
Detailed 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 .
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with vestibular schwannoma, who underwent gamma knife surgery
Condition Vestibular Schwannoma
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: March 27, 2017)
90
Original Estimated Enrollment Same as current
Study Completion Date Not Provided
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03097822
Other Study ID Numbers H-1611-087-809
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Seung Hong Choi, Seoul National University Hospital
Study Sponsor Seoul National University Hospital
Collaborators Not Provided
Investigators
Principal Investigator: SeungHong Choi, MD,PhD Seoul National University Hospital(Radiology)
PRS Account Seoul National University Hospital
Verification Date March 2017