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Recruiting NCT02619890

Brain Glioma Registry Combining Clinical and Imaging Information

— Observational Adult Glioma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Brain Glioma Registry.
Who it may be relevant to
Registry conditions: Adult Glioma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

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.

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

Primary outcome 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 outcome measures (4)
  • 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)]
  • One- year survival [Time frame: One year]
  • Overall Survival [Time frame: 5 years]
  • Identification of Imaging biomarkers of clinical significance (prognostic) [Time frame: 5 years]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

South Korea · 1 center
  • Asan Medical Center — Seoul

Publications

  • 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. PMID 25213869
  • 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. PMID 24516010
  • Moon HH, Wongsawaeng D, Park JE, Park SY, Baek S, Kim YH, Song SW, Hong CK, Kim JH, Lee MH, Park YW, Ahn SS, Pollock JM, Barajas RF Jr, Kim HS. Maximum Resection of Noncontrast-enhanced Tumor at MRI Is a Favorable Prognostic Factor in IDH Wild-Type Glioblastoma. Radiology. 2025 May;315(2):e241393. doi: 10.1148/radiol.241393. PMID 40326876
  • Park JE, Kim HS, Kim N, Park SY, Kim YH, Kim JH. Spatiotemporal Heterogeneity in Multiparametric Physiologic MRI Is Associated with Patient Outcomes in IDH-Wildtype Glioblastoma. Clin Cancer Res. 2021 Jan 1;27(1):237-245. doi: 10.1158/1078-0432.CCR-20-2156. Epub 2020 Oct 7. PMID 33028594
  • Park JE, Kim HS, Park SY, Nam SJ, Chun SM, Jo Y, Kim JH. Prediction of Core Signaling Pathway by Using Diffusion- and Perfusion-based MRI Radiomics and Next-generation Sequencing in Isocitrate Dehydrogenase Wild-type Glioblastoma. Radiology. 2020 Feb;294(2):388-397. doi: 10.1148/radiol.2019190913. Epub 2019 Dec 17. PMID 31845844

Identifiers

NCT: NCT02619890 · AsanMCHSKim_02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗