Brain Tumor Intraoperative Ultrasound Database

NCT05062772 | Completed

• 1 other identifier: 21-PI085
• Study Type: observational
• Target: 150
• Locations: 5 countries
• Sites: 6

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.

Conditions

Brain Tumor; Brain Neoplasms; Brain Cancer; Glioma; Glioblastoma

Keywords

glioma; glioblastoma; brain tumor; ultrasound; intraoperative ultrasound

Outcome Measures

Primary Outcomes (1)

• Overall survival

  Overall survival in glioblastoma

  1 year

Study Arms (1)

Glioblastoma

Diagnostic Test: Ultrasound

Interventions

Ultrasound DIAGNOSTIC_TEST

Intraoperative ultrasound imaging

Glioblastoma

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital del Rio Hortega: lead

Study Sites (6)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Hôpital Bretonneau, CHRU de Tours

Tours, 37044, France

Location

Tata Memorial Centre

Mumbai, Parel, 400012, India

Location

Fondazione Irccs Istituto Neurologico "Carlo Besta"

Milan, 20133, Italy

Location

Unit of Neurosurgery, Department of Biomedicine Neurosciences and Advanced Diagnsotics, University of Palermo

Palermo, 90100, Italy

Location

University Hospital Rio Hortega

Valladolid, 47012, Spain

Location

Related Publications (7)

• 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.

  PMID: 33932930 BACKGROUND

• 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.

  PMID: 33669989 BACKGROUND

• 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.

  PMID: 33654554 BACKGROUND

• 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.

  PMID: 33604286 BACKGROUND

• 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.

  PMID: 33594589 BACKGROUND

• 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.

  PMID: 33259973 BACKGROUND

• 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.

  PMID: 31790843 BACKGROUND

Related Links

• Institution Website

MeSH Terms

Conditions

Brain Neoplasms; Glioma; Glioblastoma

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Astrocytoma

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Santiago Cepeda, MD, PhD

  Department of Neurosurgery University Hospital Río Hortega

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: September 21, 2021
• First Posted: September 30, 2021
• Study Start: May 25, 2022
• Primary Completion: November 14, 2024
• Study Completion: November 14, 2024
• Last Updated: November 15, 2024

Record last verified: 2024-11

Locations

IT (2); ES (1); IN (1); US (1); FR (1)