ALBATROSS Study: International Multicenter Study for Prospective Validation of Imaging Biomarkers Calculated at Vascular Habitats of High-grade Gliomas

Study Purpose

This Clinical study is framed in the ALBATROSS Project: Clinically validated decision support system based on pixel level Artificial Intelligent models for deciding treatment in glioblastoma. The prospective multicenter international dataset compiled during the ALBATROSS project will include a cohort up to 300 new patients diagnosed with GB after June 1, 2020. Longitudinal images (T1, T2, T1c, FLAIR, PWI-DSC and DWI at least), complete molecular profiling, primary and secondary lines of treatment and clinical conditions will be included for each patient.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.

Searching Both is inclusive of interventional and observational studies.

Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Patients diagnosed with astrocytoma grade IV WHO with histopathological/genetic confirmation who undergo the Stupp treatment.
  • - Age > 18 years at diagnosis.
  • - Patients with access to complete preoperative, postoperative and follow up MRI studies, including: - Pre gadolinium T1-weighted MRI.
  • - Post gadolinium T1-wighted MRI.
  • - T2-weighted MRI.
  • - 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:

  • - 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

Trial Details

Trial ID:

This trial id was obtained from, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.


Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Juan M Garcia-Gomez
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Overall Status Recruiting
Countries Spain

The disease, disorder, syndrome, illness, or injury that is being studied.

Astrocytoma, Grade IV
Additional Details

The Hypothesis under study in this project is: Therapeutic decision making during clinical management of patients with glioblastoma may benefit from delineating functional habitats at pixel level relative to growth, proliferation, infiltration and angiogenesis. The Overall Scientific Objectives of the research proposal are to: OSO1. Delineate functional habitats from multiparametric MRI relative to the growth, proliferation, infiltration and angiogenesis at the enhanced tumor and infiltrated peripheral edema OSO2. Demonstrate that functional habitats at enhanced tumors and infiltrated peripheral edema show structural, cellular and molecular differences related to the heterogeneity of the tumor region and are compatible with mathematical models of glioma growth and infiltration OSO3. Determine the in-vivo molecular sub-type of patients with glioblastoma from image biomarkers in functional habitats OSO4. Identify groups of patients with glioblastoma presenting positive therapeutic response in terms of longer survival using image biomarkers from functional habitats OSO5. Position ONCOhabitats as a clinical decision support system for the management of patients with glioblastoma

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Universitat Politècnica de València, Valencia, Spain




Universitat Politècnica de València

Valencia, , 46021

Site Contact

María del Mar Álvarez-Torres, mS


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