Clinical trial · Observational
BIOhabitats: Biological Validation of Vascular Habitats Within Astrocytoma Grade 4 at Molecular, Cellular, and Histopathological Levels
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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 molecular levels. II. To analyze the associations between the perfusion imaging markers and relevant molecular markers at the HTS habitats for high-grade glioma diagnosis, prognosis/aggressiveness, progression and/or prediction. III. To analyze the associations between the perfusion imaging markers and immune markers at the HTS habitats useful in immunotherapy evaluation and/or patient selection. IV. To prospectively validate the prognostic capacity (association with OS and PFS) and stratification capacity of the perfusion imaging markers calculated at the HTS habitats.
Conditions
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Astrocytoma, Grade IV | Astrocytoma | CURATED_BROADER | 0.80 |
| Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
| Glioblastoma IDH (Isocitrate Dehydrogenase) Mutant | — | UNRESOLVED | — |
| Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype | — | UNRESOLVED | — |
| Glioblastoma, IDH-mutant | Astrocytoma, IDH-Mutant, Grade 4 | ALIAS | 0.90 |
| Glioblastoma, IDH-wildtype | Glioblastoma, IDH-Wildtype | ONTOLOGY_EXACT | 0.90 |
| Glioblastoma Multiforme | Glioblastoma | CURATED_BROADER | 0.80 |
| High Grade Glioma | High-Grade Glioma, NOS |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Adults patients with astrocytoma grade 4
Primary outcomes (3)
- measure
- Molecular profile of each vascular habitat biopsied for each included patient
- timeFrame
- through study completion, an average of 1 year
- description
- Molecular profile of each vascular habitat biopsied for each included patient, including main molecular alterations typically found in astrocytoma grade 4
- measure
- Description at cellular level of each vascular habitat biopsied for each included patient, including cell types and cell density
- timeFrame
- through study completion, an average of 1 year
- description
- Description at cellular level of each vascular habitat biopsied for each included patient, including cell types and cell density
- measure
- Description at histopathological level of each vascular habitat biopsied for each included patient, including tissues, necrosis, vascularuture
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 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 Criteria: 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
References
Publications (0)
Data not yet available