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Brain Tumor Intraoperative Ultrasound Database

Study Purpose

Predicting the survival of patients diagnosed with glioblastoma (GBM) is essential to guide surgical strategy and subsequent adjuvant therapies. Intraoperative ultrasound (ioUS) is a low-cost, versatile technique available in most neurosurgical departments. The images from ioUS contain biological information possibly correlated to the tumor's behavior, aggressiveness, and oncological outcomes. Today's advanced image processing techniques require a large amount of data. Therefore, the investigators propose creating an international database aimed to share intraoperative ultrasound images of brain tumors. The acquired data must be processed to extract radiomic or texture characteristics from ioUS images. The rationale is that ultrasound images contain much more information than the human eye can process. Our main objective is to find a relationship between these imaging characteristics and overall survival (OS) in GBM. The predictive models elaborated from this imaging technique will complement those already based on other sources such as magnetic resonance imaging (MRI), genetic and molecular analysis, etc. Predicting survival using an intraoperative imaging technique affordable for most hospitals would greatly benefit the patients' management.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational [Patient Registry]
Eligible Ages 15 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Adult patients operated between January 2018 and January 2020 with a pathological diagnosis of WHO grade IV astrocytoma (Glioblastoma).
  • - Intraoperative ultrasound study that includes B-mode images.

Exclusion Criteria:

  • - Other histopathological diagnoses.
Even though the international database will be established in such a way that other tumor types can be included prospectively.
  • - Artifacts in ultrasound images that make their analysis impossible.
  • - Stereotactic biopsies.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05062772
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Hospital del Río Hortega
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Santiago Cepeda, MD, PhD
Principal Investigator Affiliation Department of Neurosurgery University Hospital Río Hortega
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries India, Italy, Spain
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Brain Tumor, Brain Neoplasms, Brain Cancer, Glioma, Glioblastoma
Study Website: View Trial Website
Additional Details

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. Hypotheses. Intraoperative ultrasound images in B-mode harbour tumor texture features correlated with overall survival in glioblastomas. Objectives:

  • - 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.

Arms & Interventions

Arms

: Glioblastoma

Interventions

Diagnostic Test: - Ultrasound

Intraoperative ultrasound imaging

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Tata Memorial Centre, Mumbai, Parel, India

Status

Recruiting

Address

Tata Memorial Centre

Mumbai, Parel, 400012

Site Contact

Vikas Singh, Dr.

drvikaskumarsingh@gmail.com

+34651035158

Milan, Italy

Status

Recruiting

Address

Fondazione Irccs Istituto Neurologico "Carlo Besta"

Milan, , 20133

Site Contact

Massimiliano Del Bene, MD

massimiliano.delbene@istituto-besta.it

02.70638217

Palermo, Italy

Status

Recruiting

Address

Unit of Neurosurgery, Department of Biomedicine Neurosciences and Advanced Diagnsotics, University of Palermo

Palermo, , 90100

Site Contact

Giuseppe Roberto Giammalva, MD

robertogiammalva@live.it

091 238 86472

University Hospital Rio Hortega, Valladolid, Spain

Status

Recruiting

Address

University Hospital Rio Hortega

Valladolid, , 47012

Site Contact

Santiago Cepeda, MD., PhD.

scepedac@saludcastillayleon.es

+34651035158