Brain Glioma Registry Combining Clinical and Imaging Information

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое Brain Glioma Registry

Первичные конечные точки

• Documentation of clinical information (demographics and Karnofsky performance score) [Срок оценки: 5 years per patient]
• Documentation of treatment [Срок оценки: 5 years per patient]
• Documentation of radiologic information of conventional MR imaging and advanced MR imaging [Срок оценки: 5 years per patient]

Вторичные конечные точки (4)

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

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

South Korea · 1 центр

• Asan Medical Center — Seoul

Публикации

• 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

Идентификаторы

NCT: NCT02619890 · AsanMCHSKim_02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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