Glioblastoma Clinical Trial
Official title:
Multicentre Validation of Hemodynamic Multiparametric Tissue Signature (MTS) Biomarkers From Preoperative and Postradiotherapy MRI in Patients With Glioblastoma: Predictors of Overall Survival
Despite an aggressive therapeutic approach, the prognosis for most patients with glioblastoma
(GBM) remains poor. The relationship between non-invasive Magnetic Resonance Imaging (MRI)
biomarkers at preoperative, postradiotherapy and follow-up stages, and the survival time in
GBM patients will be useful to plan an optimal strategy for the management of the disease.
The Hemodynamic Multiparametric Tissue Signature (HTS) biomarker provides an automated
unsupervised method to describe the heterogeneity of the enhancing tumor and edema areas in
terms of the angiogenic process located at these regions. This allows to automatically draw 4
reproducible habitats that describe the tumor vascular heterogeneity:
- The High Angiogenic enhancing Tumor (HAT)
- The Less Angiogenic enhancing Tumor (LAT)
- The potentially tumor Infiltrated Peripheral Edema (IPE)
- The Vasogenic Peripheral Edema (VPE)
The conceptual hypothesis is that there is a significant correlation between the perfusion
biomarkers located at several HTS habitats and the patient's overall survival.
The primary purpose of this clinical study is to determine if preoperative vascular
heterogeneity of glioblastoma is predictive of overall survival of patients undergoing
standard-of-care treatment by using the HTS biomarker.
This is a multicenter observational retrospective study with data collected from Hospital
Information System (HIS) and Picture Archiving and Communication System (PACS) of each center
involved in the study. The cohort is built with patients diagnosed with glioblastoma (GBM)
with a Magnetic Resonance Imaging (MRI) pre-treatment since 1st of January of 2012 until the
Study Start Date.
The main objective of the study is to determine if the habitats obtained by the Hemodynamic
Multiparametric Tissue Signature (HTS) biomarker, which describe the tumor vascular
heterogeneity of the enhancing tumor and edema areas, are predictive of the overall survival
of patients undergoing standard-of-care treatment.
The specific objectives of the study are:
- To identify four habitats within the GBM using MRI and HTS
- To analyse the relation between the HTS habitats obtained from the first preoperative
MRI and the overall survival of the patient
- To analyse the relation between HTS habitats obtained from the first preoperative MRI
and the progression-free survival of the patient
- To analyse the relation between the HTS habitats obtained from the postradiotherapy MRI
and the overall survival of the patient
- To analyse the relation between HTS habitats obtained from the postradiotherapy MRI and
the progression-free survival of the patient
- To discover other interesting relations between the HTS habitats obtained from
preoperative, postradiotherapy and follow-up images and the clinical conditions of the
patients
Cox regression, Kaplan-Meier estimator and multiple linear regression analysis will be used
to assess survival significance of each biomarker at each HTS habitat. The predictive value
will be compared with models based on clinical and volumetric image variables: Age, Karnofsky
Performance Status (KPS) Scale and Visually AcceSAble Rembrandt Images (VASARI) features.
Moreover, the HTS-based models will be compared to models based on hemodynamic biomarkers,
such as Cerebral Blood Flow (CBF), Cerebral Blood Volume (CBV), capillary permeability
(Ktrans) and fractional Volume of Extravascular-Extracellular space (Ve), and diffusion
biomarkers, such as Apparent Diffusion Coefficient (ADC), extracted from automatic
segmentations of the edema and the enhancing tumor. Finally, Sørensen-Dice coefficient will
be used to measure the correlation between MTS habitats in longitudinal studies.
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