Brain Tumor Intraoperative Ultrasound Database (BraTioUS-DB)
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|ClinicalTrials.gov Identifier: NCT05062772|
Recruitment Status : Not yet recruiting
First Posted : September 30, 2021
Last Update Posted : October 8, 2021
|Condition or disease||Intervention/treatment|
|Brain Tumor Brain Neoplasms Brain Cancer Glioma Glioblastoma||Diagnostic Test: Ultrasound|
The investigators plan to carry out a multicentre retrospective study of patients operated with GBM diagnosis between January 2018 and January 2020, in order to set the base for future prospective collection of patients. All cases with an ioUS study will be included. All patients must count with B-mode modality. After an pseudonymization process, the images will be uploaded to a private cloud server. Demographic, clinical, conventional radiological, and molecular variables (IDH, MGMT) will also be collected. OS will be defined as the time elapsed between the histopathological diagnosis and the patient's death. The acquired data must be processed to obtain a series of radiomic markers to perform the study. A pre-processing stage will be necessary (noise cleaning, despeckling, intensity normalization, filtering) to calculate radiomics measurements (histogram, volumetric, shape, texture, etc.). In the previous stage, a very high number of radiological features per subject will be calculated. Because the number of features is much higher than the data set, to avoid the curse of dimensionality, it will be necessary to reduce their number using feature selection and extraction techniques (standard in pattern recognition and radiomics) that allow choosing those characteristics (or transformations of them) that have greater discriminating power. A predictive model of survival will then be elaborated based on the features selected.
Intraoperative ultrasound images in B-mode harbour tumor texture features correlated with overall survival in glioblastomas.
- To determine the relationship between the radiomic features of intraoperative ultrasound B-mode and overall survival in glioblastomas.
- Develop a predictive survival model using the texture features with the highest discriminatory power.
- Validate the model against an external dataset and compare it with currently available predictive models.
- Build a data set that allows exploring various image harmonization techniques that allow the reproducibility of our predictions.
- Establish an international cooperation network (BraTioUS-DB) whose objective will be to interchange ultrasound images and clinical data of patients operated on for a brain tumor prospectively from its creation and start-up.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||100 participants|
|Target Follow-Up Duration:||1 Year|
|Official Title:||Predicting Overall Survival in Glioblastomas Using Radiomic Features of Intraoperative Ultrasound. A Proposal for the Creation of an International Database of Brain Tumor Ultrasound Images|
|Estimated Study Start Date :||November 1, 2021|
|Estimated Primary Completion Date :||April 30, 2022|
|Estimated Study Completion Date :||November 30, 2022|
Diagnostic Test: Ultrasound
Intraoperative ultrasound imaging
- Overall survival [ Time Frame: 1 year ]Overall survival in glioblastoma
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05062772
|University Hospital Rio Hortega|
|Valladolid, Spain, 47012|
|Contact: Santiago Cepeda, MD., PhD. +34651035158 email@example.com|
|Principal Investigator: Santiago Cepeda, MD., PhD.|
|Sub-Investigator: Sergio García-García, MD., PhD.|
|Sub-Investigator: Rosario Sarabia, MD., PhD.|
|Sub-Investigator: Ignacio Arrese, MD., PhD.|