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临床试验/NCT05062772
NCT05062772已完成不适用

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

Hospital del Rio Hortega6 个研究点 分布在 5 个国家目标入组 150 人开始时间: 2022年5月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
150
试验地点
6
主要终点
Overall survival

研究概览

简要总结

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.

详细描述

The investigators plan to carry out a multicentre retrospective study of patients operated with GBM diagnosis between January 2018 and January 2020, in order to set the base for future prospective collection of patients. All cases with an ioUS study will be included. All patients must count with B-mode modality. After an pseudonymization process, the images will be uploaded to a private cloud server. Demographic, clinical, conventional radiological, and molecular variables (IDH, MGMT) will also be collected. OS will be defined as the time elapsed between the histopathological diagnosis and the patient's death. The acquired data must be processed to obtain a series of radiomic markers to perform the study. A pre-processing stage will be necessary (noise cleaning, despeckling, intensity normalization, filtering) to calculate radiomics measurements (histogram, volumetric, shape, texture, etc.). In the previous stage, a very high number of radiological features per subject will be calculated. Because the number of features is much higher than the data set, to avoid the curse of dimensionality, it will be necessary to reduce their number using feature selection and extraction techniques (standard in pattern recognition and radiomics) that allow choosing those characteristics (or transformations of them) that have greater discriminating power. A predictive model of survival will then be elaborated based on the features selected.

Hypotheses

Intraoperative ultrasound images in B-mode harbour tumor texture features correlated with overall survival in glioblastomas.

Objectives:

  • To determine the relationship between the radiomic features of intraoperative ultrasound B-mode and overall survival in glioblastomas.
  • Develop a predictive survival model using the texture features with the highest discriminatory power.
  • Validate the model against an external dataset and compare it with currently available predictive models.
  • Build a data set that allows exploring various image harmonization techniques that allow the reproducibility of our predictions.
  • Establish an international cooperation network (BraTioUS-DB) whose objective will be to interchange ultrasound images and clinical data of patients operated on for a brain tumor prospectively from its creation and start-up.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

年龄范围
15 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

结局指标

主要结局

Overall survival

时间窗: 1 year

Overall survival in glioblastoma

次要结局

未报告次要终点

研究者

发起方
Hospital del Rio Hortega
申办方类型
Other
责任方
Principal Investigator
主要研究者

Santiago Cepeda

Principal investigator

Hospital del Rio Hortega

研究点 (6)

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