Status:
COMPLETED
Multicentre Validation of How Vascular Biomarkers From Tumor Can Predict the Survival of the Patient With Glioblastoma
Lead Sponsor:
Juan M Garcia-Gomez
Collaborating Sponsors:
University of Liege
Hospital de Manises
Conditions:
Glioblastoma
Eligibility:
All Genders
18+ years
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 p...
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 ...
Eligibility Criteria
Inclusion
- Patients diagnosed with Glioblastoma grade IV WHO with histopathological confirmation
- Age \>18 years at diagnosis
- Patients with access to the preoperative and postradiotherapy MRI studies using 1.5 Tesla (T) or 3T scanners, including: pre and post gadolinium T1-weighted MRI, T2-weighted MRI, FLAIR MRI, Dynamic Susceptibility Contrast (DSC) T2\*-weighted perfusion, Dynamic Contrast Enhancement (DCE) T1-weighted perfusion (optional) and Diffusion Weighted Imaging (DWI) (optional)
- WHO performance score between 0 and 2
- Patients with Karnofsky Performance Score (KPS) of ≥ 70%
Exclusion
- Patients with congestive heart failure within 6 months prior to study entry (New York Heart Association ≥ Grade 3)
- Uncontrolled or significant cardiovascular disease, including: myocardial infarction and transient ischemic attack or stroke within 6 months prior to enrollment, uncontrolled angina within 6 months, diagnosed or suspected congenital long QT syndrome, any history of clinically significant ventricular arrhythmia (such as ventricular tachycardia, ventricular fibrillation or Torsades de pointes) and clinically significant abnormality on electrocardiogram (ECG)
- Pulmonary disease including or greater than grade 2 dyspnea or laryngeal edema, grade 3 pulmonary edema or pulmonary hypertension according to CTCAE 4.03
Key Trial Info
Start Date :
February 7 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2019
Estimated Enrollment :
305 Patients enrolled
Trial Details
Trial ID
NCT03439332
Start Date
February 7 2018
End Date
March 1 2019
Last Update
July 8 2025
Active Locations (1)
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1
Universitat Politècnica de València
Valencia, Spain, 46022