Brain Tumor Intraoperative Ultrasound Database (BraTioUS-DB)

  • STATUS
    Recruiting
  • End date
    Nov 30, 2023
  • participants needed
    100
  • sponsor
    Hospital del Río Hortega
Updated on 5 June 2022
astrocytoma
brain tumor

Summary

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.

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.

Details
Condition Brain Tumor, Brain Neoplasms, Brain Cancer, Glioma, Glioblastoma
Treatment ultrasound
Clinical Study IdentifierNCT05062772
SponsorHospital del Río Hortega
Last Modified on5 June 2022

Eligibility

Yes No Not Sure

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note