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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
Sponsor:
Information provided by (Responsible Party):
Santiago Cepeda, Hospital del Río Hortega

Brief 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.

Condition or disease Intervention/treatment
Brain Tumor Brain Neoplasms Brain Cancer Glioma Glioblastoma Diagnostic Test: Ultrasound

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Other
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

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Glioblastoma Diagnostic Test: Ultrasound
Intraoperative ultrasound imaging




Primary Outcome Measures :
  1. Overall survival [ Time Frame: 1 year ]
    Overall survival in glioblastoma



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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.
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.

Information from the National Library of Medicine

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


Locations
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Spain
University Hospital Rio Hortega
Valladolid, Spain, 47012
Contact: Santiago Cepeda, MD., PhD.    +34651035158    scepedac@saludcastillayleon.es   
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.         
Sponsors and Collaborators
Hospital del Río Hortega
  Study Documents (Full-Text)

Documents provided by Santiago Cepeda, Hospital del Río Hortega:
Study Protocol  [PDF] July 12, 2021

Additional Information:
Publications:

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Responsible Party: Santiago Cepeda, Principal investigator, Hospital del Río Hortega
ClinicalTrials.gov Identifier: NCT05062772    
Other Study ID Numbers: 21-PI085
First Posted: September 30, 2021    Key Record Dates
Last Update Posted: October 8, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Santiago Cepeda, Hospital del Río Hortega:
glioma
glioblastoma
brain tumor
ultrasound
intraoperative ultrasound
Additional relevant MeSH terms:
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Glioblastoma
Glioma
Brain Neoplasms
Neoplasms
Astrocytoma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases