Status:
COMPLETED
BIOhabitats: Biological Validation of Vascular Habitats Within Astrocytoma Grade 4 at Molecular, Cellular, and Histopathological Levels
Lead Sponsor:
Juan M Garcia-Gomez
Collaborating Sponsors:
Hospital Clínico Universitario de Valencia
Hospital Universitario 12 de Octubre
Conditions:
Astrocytoma, Grade IV
Glioblastoma
Eligibility:
All Genders
18+ years
Brief Summary
The main purposes of this study are: I. To assess that the four habitats within the tumor (HAT and LAT) and edema (IPE and VPE) in high-grade glioma are different at vascular, tissular, cellular and ...
Detailed Description
High-grade glioma (HGG) are the most aggressive malignant primary brain tumor in adults with a median survival rate of 12-15 months. It still carries a poor prognosis despite aggressive treatment, whi...
Eligibility Criteria
Inclusion
- Patients diagnosed with Astrocitoma, Grade 4, cIMPACT-NOW: update 6 classification with histopathological/genetic confirmation who undergo the Stupp treatment
- Age \> 18 years at diagnosis
- Patients with access to complete pre-operative MRI studies, including:
- Pre gadolinium T1-weighted MRI
- Post gadolinium T1-wighted MRI
- T2-weighted MRI
- T2-Fluid-Attenuated Inversion Recovery (FLAIR)
- Dynamic Susceptibility Contrast (DSC) T2\*-weighted perfusion sequences
- Diffusion Weighted Imaging (DWI)
- Patients who undergo surgery with the possibility to collect samples from different regions of the tumor
Exclusion
- 6
- Patient 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 arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de pointes)
- 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 :
March 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2022
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05375318
Start Date
March 1 2021
End Date
July 1 2022
Last Update
July 8 2025
Active Locations (1)
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1
Biomedical Data Science Lab. Universitat Politècnica de València
Valencia, Valencia, Spain, 46022