NCT05062772: BraTioUS-DB

Brain Tumor Intraoperative Ultrasound Database

Completed Last updated 15 November 2024

What this trial tests

trial testing Ultrasound in Brain Tumor in 150 participants. Completed in 14 November 2024.

Timeline

25 May 2022

Primary endpoint
14 November 2024

14 November 2024

Quick facts

Lead sponsor	Hospital del Rio Hortega
Status	Completed
Study type	OBSERVATIONAL
Enrollment	150
Start date	25 May 2022
Primary completion	14 November 2024
Estimated completion	14 November 2024
Sites	6 locations across France, Italy, United States, Spain, India

Drugs / interventions tested

• Ultrasound

Conditions studied

• Brain Tumor — all drugs for Brain Tumor →
• Brain Neoplasms — all drugs for Brain Neoplasms →
• Brain Cancer — all drugs for Brain Cancer →
• Glioma — all drugs for Glioma →

Sponsor

Hospital del Rio Hortega

Who can join

15 and older, any sex, with Brain Tumor or Brain Neoplasms. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Deep Learning-Based Glioma Segmentation of 2D Intraoperative Ultrasound Images: A Multicenter Study Using the Brain Tumor Intraoperative Ultrasound Database (BraTioUS).
   Cepeda S, Esteban-Sinovas O, Singh V, Shetty P, et al · · 2025 · cited 6× · PMID 39858097 · DOI 10.3390/cancers17020315
2. Intraoperative Evaluation of Brain-Tumor Microvascularization through MicroV IOUS: A Protocol for Image Acquisition and Analysis of Radiomic Features.
   Giammalva GR, Viola A, Maugeri R, Giardina K, et al · · 2022 · cited 6× · PMID 36358754 · DOI 10.3390/cancers14215335
3. Prognostic Modeling of Overall Survival in Glioblastoma Using Radiomic Features Derived from Intraoperative Ultrasound: A Multi-Institutional Study.
   Cepeda S, Esteban-Sinovas O, Singh V, Moiyadi A, et al · · 2025 · cited 2× · PMID 39858063 · DOI 10.3390/cancers17020280