Brain Glioma Registry Combining Clinical and Imaging Information

Overview

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.

Full Title of Study: “Registry Describing Clinical Information, Conventional, and Advanced Magnetic Resonance Imaging Information of Patients With Brain Glioma”

Study Type

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 2040

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.

Interventions

  • Other: Brain Glioma Registry

Arms, Groups and Cohorts

  • Patients with glioma requiring treatment
    • Patients with glioma requiring treatment, who undergo 3-Tesla magnetic resonance imaging to measure tumor protein content (using CEST-MRI), cellularity (using DW-MRI), and perfusion (using DCE-MRI and DSC-MRI with IV administration of gadolinium-containing contrast agent

Clinical Trial Outcome Measures

Primary Measures

  • Documentation of clinical information (demographics and Karnofsky performance score)
    • Time Frame: 5 years per patient
  • Documentation of treatment
    • Time Frame: 5 years per patient
  • Documentation of radiologic information of conventional MR imaging and advanced MR imaging
    • Time Frame: 5 years per patient

Secondary Measures

  • Progression Free Survival (PFS)
    • Time Frame: On-study date to lesser of date of progression or date of death from any cause (assessed at 6 months)
    • Estimated probable duration of life without disease progression, from on-study date to earlier of progression date or date of death from any cause, using the Kaplan-Meier method with censoring. The response was determined by a modification of the RANO criteria that combined the image assessment, neurologic evaluation and assessment of steroid use. Complete Response (CR) was defined as complete disappearance on MR of all enhancing tumor; Partial Response (PR) was defined as greater than or equal to 50% reduction in tumor size on MR by bi-dimensional measurement; Pseudoprogression was defined when there was a decrease or stabilization of the contrast-enhancing lesions for a minimum of six months and combined with no change in treatment/ or a increase in contrast-enhancing lesion on the first subsequent follow-up MR image, as long as it stabilized on the second follow-up and there was no need for treatment change. Responder = CR+PR+Pseudoprogression, Non-responder = Progression.
  • One- year survival
    • Time Frame: One year
    • Number of months from date of diagnosis to date of death
  • Overall Survival
    • Time Frame: 5 years
  • Identification of Imaging biomarkers of clinical significance (prognostic)
    • Time Frame: 5 years

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Asan Medical Center
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ho Sung Kim, Associate Professor – Asan Medical Center
  • Overall Contact(s)
    • Ho Sung Kim, M.D.,Ph.D., +82230105682, radhskim@gmail.com

References

Mrugala MM, Engelhard HH, Dinh Tran D, Kew Y, Cavaliere R, Villano JL, Annenelie Bota D, Rudnick J, Love Sumrall A, Zhu JJ, Butowski N. Clinical practice experience with NovoTTF-100A system for glioblastoma: The Patient Registry Dataset (PRiDe). Semin Oncol. 2014 Oct;41 Suppl 6:S4-S13. doi: 10.1053/j.seminoncol.2014.09.010. Epub 2014 Sep 16. Erratum In: Semin Oncol. 2015 Jun;42(3):e33-43.

Marko NF, Weil RJ, Schroeder JL, Lang FF, Suki D, Sawaya RE. Extent of resection of glioblastoma revisited: personalized survival modeling facilitates more accurate survival prediction and supports a maximum-safe-resection approach to surgery. J Clin Oncol. 2014 Mar 10;32(8):774-82. doi: 10.1200/JCO.2013.51.8886. Epub 2014 Feb 10.

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