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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05062772




Registration number
NCT05062772
Ethics application status
Date submitted
21/09/2021
Date registered
30/09/2021
Date last updated
1/10/2024

Titles & IDs
Public title
Brain Tumor Intraoperative Ultrasound Database
Scientific 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
Secondary ID [1] 0 0
21-PI085
Universal Trial Number (UTN)
Trial acronym
BraTioUS-DB
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Brain Tumor 0 0
Brain Neoplasms 0 0
Brain Cancer 0 0
Glioma 0 0
Glioblastoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Brain

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Diagnosis / Prognosis - Ultrasound

Glioblastoma -


Diagnosis / Prognosis: Ultrasound
Intraoperative ultrasound imaging
Intervention code [1] 0 0
Diagnosis / Prognosis
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall survival
Timepoint [1] 0 0
1 year

Eligibility
Key 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
Minimum age
15 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
25/05/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/06/2025
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
India
State/province [1] 0 0
Parel
Country [2] 0 0
Italy
State/province [2] 0 0
Milan
Country [3] 0 0
Italy
State/province [3] 0 0
Palermo
Country [4] 0 0
Spain
State/province [4] 0 0
Valladolid

Funding & Sponsors
Primary sponsor type
Other
Name
Hospital del Rio Hortega
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT05062772
Trial related presentations / 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.
Cepeda 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.
Cepeda 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.
Cepeda 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.
Cepeda 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.
Cepeda 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.
Cepeda 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.
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Santiago Cepeda, MD, PhD
Address 0 0
Department of Neurosurgery University Hospital Río Hortega
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Santiago Cepeda, MD, PhD
Address 0 0
Country 0 0
Phone 0 0
+34651035158
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05062772