Brain TumorBraTioUS-DBNCT05062772
Brain Tumor Intraoperative Ultrasound Database
An observational study of Brain Tumor and Brain Neoplasms, run by Hospital del Rio Hortega at 6 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Brain Tumor, Brain Neoplasms, Brain Cancer
- What is being tested?
- Ultrasound
- How many people
- 150 participants
- Where
- 6 sitesin 5 countries
- Study dates
- 25 May 2022to 14 Nov 2024
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
6 sites in 5 countries.
6 sites in 5 countries
Italy2 sites
Fondazione Irccs Istituto Neurologico "Carlo Besta"
Milan, 20133
Unit of Neurosurgery, Department of Biomedicine Neurosciences and Advanced Diagnsotics, University of Palermo
Palermo, 90100
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
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
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.
Read the 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.
- Conditions
- Brain Tumor, Brain Neoplasms, Brain Cancer, Glioma, Glioblastoma
- Being tested
- Ultrasound
- Keywords
- glioma, glioblastoma, brain tumor, ultrasound, intraoperative ultrasound
- Medical subject headings
- Brain Neoplasms, Glioma, Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundDiagnostic test
Intraoperative ultrasound imaging
| Study group | Role | What they receive |
|---|---|---|
| Glioblastoma | Not described Receives: Diagnostic Test: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Overall survival in glioblastoma
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2021
- Study start25 May 2022
- Primary completion14 Nov 2024
- Study completion14 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Brain TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 150 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Hospital del Rio Hortega
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Santiago Cepeda, Hospital del Rio Hortega
- Investigators
- Santiago Cepeda, MD, PhD, Principal investigator, Department of Neurosurgery University Hospital Río Hortega
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05062772
- Sponsor's protocol ID
- 21-PI085
- Acronym
- BraTioUS-DB
- Status last verified
- Nov 2024
- First submitted
- 21 Sep 2021
- Last updated
- 15 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Cepeda S, Sarabia R. Letter to the Editor. Intraoperative ultrasound elastography applied in meningioma surgery. Neurosurg Focus. 2021 May;50(5):E23. doi: 10.3171/2021.1.FOCUS2115. No abstract available.
PubMed 33932930Cepeda S, Garcia-Garcia S, Velasco-Casares M, Fernandez-Perez G, Zamora T, Arrese I, Sarabia R. Is There a Relationship between the Elasticity of Brain Tumors, Changes in Diffusion Tensor Imaging, and Histological Findings? A Pilot Study Using Intraoperative Ultrasound Elastography. Brain Sci. 2021 Feb 21;11(2):271. doi: 10.3390/brainsci11020271.
PubMed 33669989Cepeda S, Garcia-Garcia S, Arrese I, Velasco-Casares M, Sarabia R. Acute changes in diffusion tensor-derived metrics and its correlation with the motor outcome in gliomas adjacent to the corticospinal tract. Surg Neurol Int. 2021 Feb 10;12:51. doi: 10.25259/SNI_862_2020. eCollection 2021.
PubMed 33654554Cepeda S, Garcia-Garcia S, Arrese I, Fernandez-Perez G, Velasco-Casares M, Fajardo-Puentes M, Zamora T, Sarabia R. Comparison of Intraoperative Ultrasound B-Mode and Strain Elastography for the Differentiation of Glioblastomas From Solitary Brain Metastases. An Automated Deep Learning Approach for Image Analysis. Front Oncol. 2021 Feb 2;10:590756. doi: 10.3389/fonc.2020.590756. eCollection 2020.
PubMed 33604286Cepeda S, Garcia-Garcia S, Arrese I, Velasco-Casares M, Sarabia R. Relationship between the overall survival in glioblastomas and the radiomic features of intraoperative ultrasound: a feasibility study. J Ultrasound. 2022 Mar;25(1):121-128. doi: 10.1007/s40477-021-00569-9. Epub 2021 Feb 16.
PubMed 33594589Cepeda S, Arrese I, Garcia-Garcia S, Velasco-Casares M, Escudero-Caro T, Zamora T, Sarabia R. Meningioma Consistency Can Be Defined by Combining the Radiomic Features of Magnetic Resonance Imaging and Ultrasound Elastography. A Pilot Study Using Machine Learning Classifiers. World Neurosurg. 2021 Feb;146:e1147-e1159. doi: 10.1016/j.wneu.2020.11.113. Epub 2020 Nov 28.
PubMed 33259973Cepeda S, Barrena C, Arrese I, Fernandez-Perez G, Sarabia R. Intraoperative Ultrasonographic Elastography: A Semi-Quantitative Analysis of Brain Tumor Elasticity Patterns and Peritumoral Region. World Neurosurg. 2020 Mar;135:e258-e270. doi: 10.1016/j.wneu.2019.11.133. Epub 2019 Nov 30.
PubMed 31790843
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05062772
- Acronym / sponsor ID
- BraTioUS-DB / 21-PI085
- Conditions
- Brain Tumor, Brain Neoplasms, Brain Cancer, Glioma, Glioblastoma
- Keywords
- glioma, glioblastoma, brain tumor, ultrasound, intraoperative ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Hospital del Rio HortegaUniversity, hospital or other
- Study start
- 25 May 2022 (actual)
- Primary completion
- 14 Nov 2024 (actual)
- Study completion
- 14 Nov 2024 (actual)
- First posted
- 30 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Glioblastoma | – | Diagnostic Test: Ultrasound |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UltrasoundIntraoperative ultrasound imaging | Diagnostic test | Glioblastoma |
Primary outcome
Overall survival
Time frame: 1 year
Overall survival in glioblastoma
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2024.
- Background: PubMed 33932930Cepeda S, Sarabia R. Letter to the Editor. Intraoperative ultrasound elastography applied in meningioma surgery. Neurosurg Focus. 2021 May;50(5):E23. doi: 10.3171/2021.1.FOCUS2115. No abstract available.
- Background: PubMed 33669989Cepeda S, Garcia-Garcia S, Velasco-Casares M, Fernandez-Perez G, Zamora T, Arrese I, Sarabia R. Is There a Relationship between the Elasticity of Brain Tumors, Changes in Diffusion Tensor Imaging, and Histological Findings? A Pilot Study Using Intraoperative Ultrasound Elastography. Brain Sci. 2021 Feb 21;11(2):271. doi: 10.3390/brainsci11020271.
- Background: PubMed 33654554Cepeda S, Garcia-Garcia S, Arrese I, Velasco-Casares M, Sarabia R. Acute changes in diffusion tensor-derived metrics and its correlation with the motor outcome in gliomas adjacent to the corticospinal tract. Surg Neurol Int. 2021 Feb 10;12:51. doi: 10.25259/SNI_862_2020. eCollection 2021.
- Background: PubMed 33604286Cepeda S, Garcia-Garcia S, Arrese I, Fernandez-Perez G, Velasco-Casares M, Fajardo-Puentes M, Zamora T, Sarabia R. Comparison of Intraoperative Ultrasound B-Mode and Strain Elastography for the Differentiation of Glioblastomas From Solitary Brain Metastases. An Automated Deep Learning Approach for Image Analysis. Front Oncol. 2021 Feb 2;10:590756. doi: 10.3389/fonc.2020.590756. eCollection 2020.
- Background: PubMed 33594589Cepeda S, Garcia-Garcia S, Arrese I, Velasco-Casares M, Sarabia R. Relationship between the overall survival in glioblastomas and the radiomic features of intraoperative ultrasound: a feasibility study. J Ultrasound. 2022 Mar;25(1):121-128. doi: 10.1007/s40477-021-00569-9. Epub 2021 Feb 16.
- Background: PubMed 33259973Cepeda S, Arrese I, Garcia-Garcia S, Velasco-Casares M, Escudero-Caro T, Zamora T, Sarabia R. Meningioma Consistency Can Be Defined by Combining the Radiomic Features of Magnetic Resonance Imaging and Ultrasound Elastography. A Pilot Study Using Machine Learning Classifiers. World Neurosurg. 2021 Feb;146:e1147-e1159. doi: 10.1016/j.wneu.2020.11.113. Epub 2020 Nov 28.
- Background: PubMed 31790843Cepeda S, Barrena C, Arrese I, Fernandez-Perez G, Sarabia R. Intraoperative Ultrasonographic Elastography: A Semi-Quantitative Analysis of Brain Tumor Elasticity Patterns and Peritumoral Region. World Neurosurg. 2020 Mar;135:e258-e270. doi: 10.1016/j.wneu.2019.11.133. Epub 2019 Nov 30.
- Institution WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Santiago Cepeda, MD, PhD principal investigator
Department of Neurosurgery University Hospital Río Hortega
6 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Tumor and Brain Neoplasms, run by Hospital del Rio Hortega at 6 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Italy, United States, France, India, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05062772, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2024.