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Clinical Trials/NCT02619890
NCT02619890
Recruiting
Not Applicable

Registry Describing Clinical Information, Conventional, and Advanced Magnetic Resonance Imaging Information of Patients With Brain Glioma

Asan Medical Center1 site in 1 country9,000 target enrollmentSeptember 2015
ConditionsAdult Glioma

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Adult Glioma
Sponsor
Asan Medical Center
Enrollment
9000
Locations
1
Primary Endpoint
Documentation of radiologic information of conventional MR imaging and advanced MR imaging
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

This registry aims to collect clinical and radiologic information including detailed clinical, conventional MR and advanced MR imaging data of patients with brain gliomas. Advanced MR imaging may include diffusion-weighted imaging, perfusion-weighted imaging (dynamic susceptibility contrast, arterial spin labeling, dynamic contrast enhancement), and chemical exchange saturation transfer (CEST) imaging. This registry will describe course of disease and long-term outcomes of brain gliomas.

Detailed Description

Though the cure for brain glioma- from low grade to glioblastoma- is yet to be found, seeking for curable treatment option is actively developing. Multimodal advanced MR imaging (contrast-enhanced T1 weighted imaging, diffusion-weighted imaging, chemical exchange saturation transfer imaging, and perfusion imaging) on 3 Tesla have shown potential in patients with glioma to monitor treatment response with quantitative assessment. To find suitable imaging biomarker for treatment response, assessing clinical and radiologic outcome for long-term is essential. The creation of a registry for brain glioma in long-term follow up provides an overview of the clinical, relevant treatment standards, advanced MR imaging information, and survival data of patients and thus create opportunities for imaging biomarker research.

Registry
clinicaltrials.gov
Start Date
September 2015
End Date
December 2040
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ho Sung Kim

Associate Professor

Asan Medical Center

Eligibility Criteria

Inclusion Criteria

  • Patients must have radiologically and histologically confirmed diagnosis of Brain Glioma
  • Life expectancy of greater than 3 months
  • Must receive a first- or second-line therapy
  • Signed informed consent

Exclusion Criteria

  • No brain gliomas
  • Patients who have any type of bioimplant activated by mechanical, electronic, or magnetic means (e.g., cochlear implants, pacemakers, neurostimulators, biostimulates, electronic infusion pumps, etc), because such devices may be displaced or malfunction
  • Patients who are pregnant or breast feeding; urine pregnancy test will be performed on women of child bearing potential

Outcomes

Primary Outcomes

Documentation of radiologic information of conventional MR imaging and advanced MR imaging

Time Frame: 5 years per patient

Documentation of clinical information (demographics and Karnofsky performance score)

Time Frame: 5 years per patient

Documentation of treatment

Time Frame: 5 years per patient

Secondary Outcomes

  • Progression Free Survival (PFS)(On-study date to lesser of date of progression or date of death from any cause (assessed at 6 months))
  • One- year survival(One year)
  • Identification of Imaging biomarkers of clinical significance (prognostic)(5 years)
  • Overall Survival(5 years)

Study Sites (1)

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