Clinical trial NCT02619890: Brain Glioma Registry Combining Clinical and Imaging Information
Official title: Registry Describing Clinical Information, Conventional, and Advanced Magnetic Resonance Imaging Information of Patients With Brain Glioma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Adult Glioma
Keywords: Adult Glioma
MRI
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2015-12-02
Enrollment: 9000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients of tertiary hospital center

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.

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

Primary outcomes:
measure: Documentation of clinical information (demographics and Karnofsky performance score)
timeFrame: 5 years per patient
measure: Documentation of treatment
timeFrame: 5 years per patient
measure: Documentation of radiologic information of conventional MR imaging and advanced MR imaging
timeFrame: 5 years per patient
Secondary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: On-study date to lesser of date of progression or date of death from any cause (assessed at 6 months)
measure: One- year survival
timeFrame: One year
measure: Overall Survival
timeFrame: 5 years
measure: Identification of Imaging biomarkers of clinical significance (prognostic)
timeFrame: 5 years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.