Brain Glioma Registry Combining Clinical and Imaging Information

February 6, 2020 updated by: Ho Sung Kim, Asan Medical Center

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

9000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients of tertiary hospital center

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Other: Brain Glioma Registry

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: 5 years
5 years
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.
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
Number of months from date of diagnosis to date of death
One year
Identification of Imaging biomarkers of clinical significance (prognostic)
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asan Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Anticipated)

December 1, 2040

Study Completion (Anticipated)

December 1, 2040

Study Registration Dates

First Submitted

November 30, 2015

First Submitted That Met QC Criteria

December 1, 2015

First Posted (Estimate)

December 2, 2015

Study Record Updates

Last Update Posted (Actual)

February 7, 2020

Last Update Submitted That Met QC Criteria

February 6, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AsanMCHSKim_02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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