Ignite Creation Date:
2024-05-06 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 12:40 PM
Study NCT ID:
NCT03439332
Status:
COMPLETED
Last Update Posted:
2019-05-22
First Post:
2018-02-07
Brief Title:
Multicentre Validation of How Vascular Biomarkers From Tumor Can Predict the Survival of the Patient With Glioblastoma
Sponsor:
Juan M Garcia-Gomez
Organization:
Universitat Politècnica de València
Study Overview
Official Title:
Multicentre Validation of Hemodynamic Multiparametric Tissue Signature MTS Biomarkers From Preoperative and Postradiotherapy MRI in Patients With Glioblastoma Predictors of Overall Survival
Status:
COMPLETED
Status Verified Date:
2019-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ONCOhabitats
Brief Summary:
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 patients 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
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 patients 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
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None