GlioblastomaONCOhabitatsNCT03439332
Multicentre Validation of How Vascular Biomarkers From Tumor Can Predict the Survival of the Patient With Glioblastoma
An observational study of Glioblastoma, run by Juan M Garcia-Gomez at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma
- How many people
- 305 participants
- Where
- 1 siteSpain
- Study dates
- 7 Feb 2018to 1 Mar 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The population of the target group is formed by patients diagnosed with Glioblastoma grade IV World Health Organization (WHO) with histopathological confirmation
Who may be able to join
- 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%
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multicentre Validation of Hemodynamic Multiparametric Tissue Signature (MTS) Biomarkers From Preoperative and Postradiotherapy MRI in Patients With Glioblastoma: Predictors of Overall Survival
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:
Read more
- 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.
Read the 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 study. The cohort is built with patients diagnosed with glioblastoma (GBM) with a Magnetic Resonance Imaging (MRI) pre-treatment since 1st of January of 2012 until the Study Start Date.
The main objective of the study is to determine if the habitats obtained by the Hemodynamic Multiparametric Tissue Signature (HTS) biomarker, which describe the tumor vascular heterogeneity of the enhancing tumor and edema areas, are predictive of the overall survival of patients undergoing standard-of-care treatment.
The specific objectives of the study are:
- To identify four habitats within the GBM using MRI and HTS
- To analyse the relation between the HTS habitats obtained from the first preoperative MRI and the overall survival of the patient
- To analyse the relation between HTS habitats obtained from the first preoperative MRI and the progression-free survival of the patient
- To analyse the relation between the HTS habitats obtained from the postradiotherapy MRI and the overall survival of the patient
- To analyse the relation between HTS habitats obtained from the postradiotherapy MRI and the progression-free survival of the patient
- To discover other interesting relations between the HTS habitats obtained from preoperative, postradiotherapy and follow-up images and the clinical conditions of the patients
Cox regression, Kaplan-Meier estimator and multiple linear regression analysis will be used to assess survival significance of each biomarker at each HTS habitat. The predictive value will be compared with models based on clinical and volumetric image variables: Age, Karnofsky Performance Status (KPS) Scale and Visually AcceSAble Rembrandt Images (VASARI) features. Moreover, the HTS-based models will be compared to models based on hemodynamic biomarkers, such as Cerebral Blood Flow (CBF), Cerebral Blood Volume (CBV), capillary permeability (Ktrans) and fractional Volume of Extravascular-Extracellular space (Ve), and diffusion biomarkers, such as Apparent Diffusion Coefficient (ADC), extracted from automatic segmentations of the edema and the enhancing tumor. Finally, Sørensen-Dice coefficient will be used to measure the correlation between MTS habitats in longitudinal studies.
- Conditions
- Glioblastoma
- Keywords
- Highly infiltrative, Deeply invasive, Strong vascular proliferation, Robust angiogenesis, Vascular heterogeneity, Perfusion Biormarker, Non-Invasive Biomarker, Predictor of overall survival, Predictor of progression-free survival
- Medical subject headings
- Glioblastoma
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
The progression-free survival for each patient is estimated since the date of the preoperative MRI to the date of recurrence.
Measured: 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
In order to study this outcome, the postradiotherapy and the follow-up images in combination with the preoperative ones, will be used.
Measured: From the date of the first MRI acquisition until the date of death from any cause, assessed up to 80 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2018
- Study start7 Feb 2018
- Primary completion1 Jul 2018
- Study completion1 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 305 participants (actual)
Sponsor and investigators
- Lead sponsor
- Juan M Garcia-Gomez
- Sponsor type
- University, hospital or other
- Collaborators
- University of Liege, Hospital de Manises, Hospital de la Ribera, Hospital Vall d'Hebron, Hospital Clinic of Barcelona, Azienda Ospedaliero-Universitaria di Parma, Oslo University Hospital
- Responsible party
- Sponsor-investigator, Juan M Garcia-Gomez, Universitat Politècnica de València
- Investigators
- Juan M Garcia Gomez, PhD, Principal investigator, Universitat Politècnica de València
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03439332
- Sponsor's protocol ID
- UPV-2018-001
- Acronym
- ONCOhabitats
- Status last verified
- Jul 2025
- First submitted
- 7 Feb 2018
- Last updated
- 8 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 29357274Juan-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.
PubMed 25978453Del 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.
PubMed 31654541
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentre Validation of Hemodynamic Multiparametric Tissue Signature (MTS) Biomarkers From Preoperative and Postradiotherapy MRI in Patients With Glioblastoma: Predictors of Overall Survival
- ClinicalTrials.gov ID
- NCT03439332
- Acronym / sponsor ID
- ONCOhabitats / UPV-2018-001
- Conditions
- Glioblastoma
- Keywords
- Highly infiltrative, Deeply invasive, Strong vascular proliferation, Robust angiogenesis, Vascular heterogeneity, Perfusion Biormarker, Non-Invasive Biomarker, Predictor of overall survival
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 305 participants (actual)
- Lead sponsor
- Juan M Garcia-GomezUniversity, hospital or other
- Collaborators
- University of Liege, Hospital de Manises, Hospital de la Ribera, Hospital Vall d'Hebron, Hospital Clinic of Barcelona, Azienda Ospedaliero-Universitaria di Parma, Oslo University Hospital
- Study start
- 7 Feb 2018 (actual)
- Primary completion
- 1 Jul 2018 (actual)
- Study completion
- 1 Mar 2019 (actual)
- First posted
- 20 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 study. The cohort is built with patients diagnosed with glioblastoma (GBM) with a Magnetic Resonance Imaging (MRI) pre-treatment since 1st of January of 2012 until the Study Start Date.
The main objective of the study is to determine if the habitats obtained by the Hemodynamic Multiparametric Tissue Signature (HTS) biomarker, which describe the tumor vascular heterogeneity of the enhancing tumor and edema areas, are predictive of the overall survival of patients undergoing standard-of-care treatment.
The specific objectives of the study are:
- To identify four habitats within the GBM using MRI and HTS
- To analyse the relation between the HTS habitats obtained from the first preoperative MRI and the overall survival of the patient
- To analyse the relation between HTS habitats obtained from the first preoperative MRI and the progression-free survival of the patient
- To analyse the relation between the HTS habitats obtained from the postradiotherapy MRI and the overall survival of the patient
- To analyse the relation between HTS habitats obtained from the postradiotherapy MRI and the progression-free survival of the patient
- To discover other interesting relations between the HTS habitats obtained from preoperative, postradiotherapy and follow-up images and the clinical conditions of the patients
Cox regression, Kaplan-Meier estimator and multiple linear regression analysis will be used to assess survival significance of each biomarker at each HTS habitat. The predictive value will be compared with models based on clinical and volumetric image variables: Age, Karnofsky Performance Status (KPS) Scale and Visually AcceSAble Rembrandt Images (VASARI) features. Moreover, the HTS-based models will be compared to models based on hemodynamic biomarkers, such as Cerebral Blood Flow (CBF), Cerebral Blood Volume (CBV), capillary permeability (Ktrans) and fractional Volume of Extravascular-Extracellular space (Ve), and diffusion biomarkers, such as Apparent Diffusion Coefficient (ADC), extracted from automatic segmentations of the edema and the enhancing tumor. Finally, Sørensen-Dice coefficient will be used to measure the correlation between MTS habitats in longitudinal studies.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population of the target group is formed by patients diagnosed with Glioblastoma grade IV World Health Organization (WHO) with histopathological confirmation
Key inclusion criteria (5 listed)
- 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%
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Time frame: From the date of the first MRI acquisition until the date of death from any cause, assessed up to 80 months
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.
2 secondary outcomes
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
Time frame: 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
Time frame: From the date of the first MRI acquisition until the date of death from any cause, assessed up to 80 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2025.
- Background: PubMed 29357274Juan-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.
- Background: PubMed 25978453Juan-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.
- Derived from this study: PubMed 31654541Del 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.
- In order to allow the scientific community to test the biomarker, a non-commercial research purposes platform has been created. It offers the opportunity to upload cases of glioblastoma on which different services can be applied.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juan M Garcia Gomez, PhD principal investigator
Universitat Politècnica de València
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glioblastoma, run by Juan M Garcia-Gomez at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: From the date of the first MRI acquisition until the date of death from any cause, assessed up to 80 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03439332, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2025.