NCT03439332

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 patient's 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
305

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 7, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

February 7, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 20, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

July 8, 2025

Status Verified

July 1, 2025

Enrollment Period

5 months

First QC Date

February 7, 2018

Last Update Submit

July 2, 2025

Conditions

Glioblastoma

Keywords

Highly infiltrativeDeeply invasiveStrong vascular proliferationRobust angiogenesisVascular heterogeneityPerfusion BiormarkerNon-Invasive BiomarkerPredictor of overall survivalPredictor of progression-free survival

Outcome Measures

Primary Outcomes (1)

  • Correlation between overall survival (in days) of patients undergoing standard-of-care treatment and the tumor vascular heterogeneity described by the four habitats obtained by the Hemodynamic Multiparametric Tissue Signature (HTS) biomarker

    The overall survival for each patient is estimated since the date of the preoperative Magnetic Resonance Imaging (MRI) to the exitus date. Exitus date will be collected from clinical records and should be confirmed by the main investigator from each center.

    From the date of the first MRI acquisition until the date of death from any cause, assessed up to 80 months

Secondary Outcomes (2)

  • Correlation between progression-free survival (in days) of patients undergoing standard-of-care treatment and the tumor vascular heterogeneity described by the four habitats obtained by the HTS biomarker

    From the date of the first MRI acquisition until the date of first documented progression, assessed up to 80 months

  • Correlation between MTS habitats in longitudinal studies

    From the date of the first MRI acquisition until the date of death from any cause, assessed up to 80 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The population of the target group is formed by patients diagnosed with Glioblastoma grade IV World Health Organization (WHO) with histopathological confirmation

You may qualify if:

  • 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%

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitat Politècnica de València

Valencia, 46022, Spain

Location

Related Publications (3)

  • Juan-Albarracin J, Fuster-Garcia E, Perez-Girbes A, Aparici-Robles F, Alberich-Bayarri A, Revert-Ventura A, Marti-Bonmati L, Garcia-Gomez JM. Glioblastoma: Vascular Habitats Detected at Preoperative Dynamic Susceptibility-weighted Contrast-enhanced Perfusion MR Imaging Predict Survival. Radiology. 2018 Jun;287(3):944-954. doi: 10.1148/radiol.2017170845. Epub 2018 Jan 19.

    PMID: 29357274BACKGROUND

  • Juan-Albarracin J, Fuster-Garcia E, Manjon JV, Robles M, Aparici F, Marti-Bonmati L, Garcia-Gomez JM. Automated glioblastoma segmentation based on a multiparametric structured unsupervised classification. PLoS One. 2015 May 15;10(5):e0125143. doi: 10.1371/journal.pone.0125143. eCollection 2015.

    PMID: 25978453BACKGROUND

  • Del Mar Alvarez-Torres M, Juan-Albarracin J, Fuster-Garcia E, Bellvis-Bataller F, Lorente D, Reynes G, Font de Mora J, Aparici-Robles F, Botella C, Munoz-Langa J, Faubel R, Asensio-Cuesta S, Garcia-Ferrando GA, Chelebian E, Auger C, Pineda J, Rovira A, Oleaga L, Molla-Olmos E, Revert AJ, Tshibanda L, Crisi G, Emblem KE, Martin D, Due-Tonnessen P, Meling TR, Filice S, Saez C, Garcia-Gomez JM. Robust association between vascular habitats and patient prognosis in glioblastoma: An international multicenter study. J Magn Reson Imaging. 2020 May;51(5):1478-1486. doi: 10.1002/jmri.26958. Epub 2019 Oct 26.

    PMID: 31654541DERIVED

Related Links

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

AstrocytomaGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Study Officials

  • Juan M Garcia Gomez, PhD

    Universitat Politècnica de València

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Full professor

Study Record Dates

First Submitted

February 7, 2018

First Posted

February 20, 2018

Study Start

February 7, 2018

Primary Completion

July 1, 2018

Study Completion

March 1, 2019

Last Updated

July 8, 2025

Record last verified: 2025-07

Locations

ES(1)