BIOhabitats: Biological Validation of Vascular Habitats Within Astrocytoma Grade 4 at Molecular, Cellular, and Histopathological Levels

NCT05375318 | Completed DMC

• 1 other identifier: BIOhabitats
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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 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

Astrocytoma, Grade IV; Glioblastoma; Glioblastoma Multiforme; Glioblastoma, IDH-wildtype; Glioblastoma, IDH-mutant; Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype; Glioblastoma IDH (Isocitrate Dehydrogenase) Mutant; High Grade Glioma

Keywords

Astrocytoma, Grade IV; vascularity; vascular habitats; ROIs; regions of interest; glioma segmentation; biological validation

Outcome Measures

Primary Outcomes (3)

• Molecular profile of each vascular habitat biopsied for each included patient

  Molecular profile of each vascular habitat biopsied for each included patient, including main molecular alterations typically found in astrocytoma grade 4

  through study completion, an average of 1 year

• Description at cellular level of each vascular habitat biopsied for each included patient, including cell types and cell density

  Description at cellular level of each vascular habitat biopsied for each included patient, including cell types and cell density

  through study completion, an average of 1 year

• Description at histopathological level of each vascular habitat biopsied for each included patient, including tissues, necrosis, vascularuture

  Description at histopathological level of each vascular habitat biopsied for each included patient, including tissues, necrosis, vascularuture

  through study completion, an average of 1 year

Study Arms (1)

Adults patients with astrocytoma grade 4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with astrocytoma grade 4

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Juan M Garcia-Gomez: lead
• Hospital Clínico Universitario de Valencia: collaborator
• Hospital Universitario 12 de Octubre: collaborator

Study Sites (1)

Biomedical Data Science Lab. Universitat Politècnica de València

Valencia, Valencia, 46022, Spain

Location

MeSH Terms

Conditions

Glioblastoma; Glioma

Condition Hierarchy (Ancestors)

Astrocytoma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Main Researcher. Head of Biomedical Data Science Lab at UPV

Study Record Dates

• First Submitted: February 1, 2022
• First Posted: May 16, 2022
• Study Start: March 1, 2021
• Primary Completion: February 1, 2022
• Study Completion: July 1, 2022
• Last Updated: July 8, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)