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NCT05062772Completed

Brain Tumor Intraoperative Ultrasound Database

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

Source: ClinicalTrials.gov · Last updated 15 Nov 2024

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Observational
Enrollment
150 (actual)
First submitted
21 Sept 2021
Start date
25 May 2022
Primary completion date
14 Nov 2024
Lead sponsor
Hospital del Rio Hortega
NCT number
NCT05062772

What you commit to

  • Study type: Observational
  • Participants enrolled: 150
  • From 25 May 2022 to the primary completion date, 14 Nov 2024
  • 6 sites in 5 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • 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.

Who the study is looking for

  • 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

Age in the registry: 15 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (6)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University Hospital Rio Hortega
Coordinator of this site? Confirm its status
ValladolidSpainUnknown status
Hôpital Bretonneau, CHRU de Tours
Coordinator of this site? Confirm its status
ToursFranceUnknown status
Tata Memorial Centre
Coordinator of this site? Confirm its status
MumbaiIndiaUnknown status
Fondazione IRCCS Istituto Neurologico Carlo Besta
Coordinator of this site? Confirm its status
MilanItalyUnknown status
Unit of Neurosurgery, Department of Biomedicine Neurosciences and Advanced Diagnsotics, University of Palermo
Coordinator of this site? Confirm its status
PalermoItalyUnknown status
Massachusetts General Hospital
Coordinator of this site? Confirm its status
BostonUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.