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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

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]

21-PI085

Universal Trial Number (UTN)

Trial acronym

BraTioUS-DB

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Brain Tumor

Brain Neoplasms

Brain Cancer

Glioma

Glioblastoma

Condition category

Condition code

Cancer

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]

Diagnosis / Prognosis

Comparator / control treatment

Control group

Outcomes

Primary outcome [1]

Overall survival

Timepoint [1]

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?

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]

India

State/province [1]

Parel

Country [2]

Italy

State/province [2]

Milan

Country [3]

Italy

State/province [3]

Palermo

Country [4]

Spain

State/province [4]

Valladolid

Funding & Sponsors

Primary sponsor type

Other

Name

Hospital del Río 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

Santiago Cepeda, MD, PhD

Address

Department of Neurosurgery University Hospital Río Hortega

Country

Phone

Fax

Contact person for public queries

Name

Santiago Cepeda, MD, PhD

Address

Country

Phone

+34651035158

Fax

scepedac@saludcastillayleon.es

Contact person for scientific queries

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

Undecided

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

Type	Other Details	Attachment
Study protocol		https://cdn.clinicaltrials.gov/large-docs/72/NCT05062772/Prot_000.pdf

Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT05062772

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Did you know?

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