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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

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

Condition or disease
Vestibular Schwannoma

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 .

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Study Type : Observational
Estimated Enrollment : 90 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Response Prediction After Gamma Knife Surgery (GKS) in Patients With Vestibular Schwannoma Using Dynamic Contrast-Enhanced (DCE) MR Imaging
Study Start Date : January 2017
Estimated Primary Completion Date : December 2018





Primary Outcome Measures :
  1. Tumor size change before and after surgery [ Time Frame: pre-op, Immediately after surgery ]

Secondary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with vestibular schwannoma, who underwent gamma knife surgery
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03097822


Contacts
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Contact: SeungHong Choi, MD,PhD verocay@snuh.org

Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Principal Investigator: SeungHong Choi, MD,PhD Seoul National University Hospital(Radiology)

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Responsible Party: Seung Hong Choi, SeoulNUH, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03097822     History of Changes
Other Study ID Numbers: H-1611-087-809
First Posted: March 31, 2017    Key Record Dates
Last Update Posted: March 31, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
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Neurilemmoma
Neuroma, Acoustic
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neuroma
Nerve Sheath Neoplasms
Neoplasms, Nerve Tissue
Cranial Nerve Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Peripheral Nervous System Neoplasms
Vestibulocochlear Nerve Diseases
Retrocochlear Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Otorhinolaryngologic Neoplasms
Cranial Nerve Diseases
Nervous System Diseases