Brain Tumor Intraoperative Ultrasound Database (BraTioUS-DB)

November 14, 2024 updated by: Santiago Cepeda, Hospital del Rio Hortega

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

150

Contacts and Locations

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

Study Locations

  • France
      • Tours, France, 37044
        • Hôpital Bretonneau, CHRU de Tours
  • India
    • Parel
      • Mumbai, Parel, India, 400012
        • Tata Memorial Centre
  • Italy
      • Milan, Italy, 20133
        • Fondazione IRCCS Istituto Neurologico "Carlo Besta"
      • Palermo, Italy, 90100
        • Unit of Neurosurgery, Department of Biomedicine Neurosciences and Advanced Diagnsotics, University of Palermo
  • Spain
      • Valladolid, Spain, 47012
        • University Hospital Rio Hortega
  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

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

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The cases that meet the inclusion criteria mentioned in the following section will be collected retrospectively to carry out the project's first phase. From January 2018 to January 2020, it is estimated that each center can contribute with a minimum of 20 cases. Therefore, the total sample size for this phase of the study will be approximately 120 patients.

Description

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.

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

  • Observational Models: Cohort
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Glioblastoma
Diagnostic test: Ultrasound
Intraoperative ultrasound imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 1 year
Overall survival in glioblastoma
1 year

Collaborators and Investigators

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

Sponsor

Hospital del Rio Hortega

Investigators

  • Principal Investigator: Santiago Cepeda, MD, PhD, Department of Neurosurgery University Hospital Río Hortega

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

Helpful Links

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 (Actual)

May 25, 2022

Primary Completion (Actual)

November 14, 2024

Study Completion (Actual)

November 14, 2024

Study Registration Dates

First Submitted

September 21, 2021

First Submitted That Met QC Criteria

September 29, 2021

First Posted (Actual)

September 30, 2021

Study Record Updates

Last Update Posted (Actual)

November 15, 2024

Last Update Submitted That Met QC Criteria

November 14, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-PI085

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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