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NCT Number: NCT02619890

Brain Glioma Registry Combining Clinical and Imaging Information

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.

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Key information

Conditions

Adult Glioma Glioma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Asan Medical Center

Seoul, South Korea

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Brain Glioma Registry

Other

Primary outcomes

  1. Documentation of clinical information (demographics and Karnofsky performance score)

    Time frame: 5 years per patient

  2. Documentation of treatment

    Time frame: 5 years per patient

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

    Time frame: 5 years per patient

Secondary outcomes

  1. 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.

  2. One- year survival

    Time frame: One year

    Number of months from date of diagnosis to date of death

  3. Overall Survival

    Time frame: 5 years

  4. Identification of Imaging biomarkers of clinical significance (prognostic)

    Time frame: 5 years

Study contacts

Contact information is provided by the study sponsor or research team.

Ho Sung Kim, M.D.,Ph.D.

CONTACT

[email protected]

+82230105682

Ji Eun Park, M.D.

CONTACT

[email protected]

+82230101505

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2040
Study completion
2040
First posted
Dec 2, 2015
Registry last updated
May 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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