Astrocytoma, Grade IVALBATROSSNCT05229198
ALBATROSS Study: International Multicenter Study for Prospective Validation of Imaging Biomarkers Calculated at Vascular Habitats of High-grade Gliomas
An observational study of Astrocytoma, Grade IV, run by Juan M Garcia-Gomez at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Astrocytoma, Grade IV
- How many people
- 300 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2020to 1 Jun 2023
- 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: Adults patients diagnosed with astrocytoma grade IV WHO with histopathological/genetic confirmation who undergo the Stupp treatment
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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
- Conditions
- Astrocytoma, Grade IV
- Keywords
- Astrocytoma, Grade IV, Glioblastoma, Glioblastoma IDH wildtype, Astrocytoma IDH mutant, Glioblastoma IDH mutant, High-grade glioma
- Medical subject headings
- Glioblastoma, Glioma
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
Overall Survival is defined as the time from the first presurgical MRI is taken to the patient (MR0) to death
Measured: From date of inclusion (date of first MRI) until the date of death, assessed up to 48 months
Secondary outcomes (1)
Progression Free Survival (PFS)
Progression Free Survival is defined as the time from the first presurgical MRI is taken to the patient to the detection of tumor relapse
Measured: From date of inclusion (date of first MRI) until the date of documented tumor progression, assessed up to 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2022
- Study start1 Jun 2020
- Primary completion1 Jun 2022
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Astrocytoma, Grade IVStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Juan M Garcia-Gomez
- Sponsor type
- University, hospital or other
- Collaborators
- Oslo University Hospital, Azienda Ospedaliero-Universitaria di Parma, Hospital Clinic of Barcelona, Hospital Vall d'Hebron, Hospital de la Ribera, Hospital de Manises, Centre Hospitalier Universitaire de Liege
- Responsible party
- Sponsor-investigator, Juan M Garcia-Gomez, Universitat Politècnica de València
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05229198
- Sponsor's protocol ID
- ALBATROSS Study
- Acronym
- ALBATROSS
- Status last verified
- Feb 2022
- First submitted
- 27 Jan 2022
- Last updated
- 8 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
- ALBATROSS Study: International Multicenter Study for Prospective Validation of Imaging Biomarkers Calculated at Vascular Habitats of High-grade Gliomas
- ClinicalTrials.gov ID
- NCT05229198
- Acronym / sponsor ID
- ALBATROSS / ALBATROSS Study
- Conditions
- Astrocytoma, Grade IV
- Keywords
- Astrocytoma, Grade IV, Glioblastoma, Glioblastoma IDH wildtype, Astrocytoma IDH mutant, Glioblastoma IDH mutant, High-grade glioma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Juan M Garcia-GomezUniversity, hospital or other
- Collaborators
- Oslo University Hospital, Azienda Ospedaliero-Universitaria di Parma, Hospital Clinic of Barcelona, Hospital Vall d'Hebron, Hospital de la Ribera, Hospital de Manises, Centre Hospitalier Universitaire de Liege
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 8 Feb 2022 (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.
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.
Detailed description
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults patients diagnosed with astrocytoma grade IV WHO with histopathological/genetic confirmation who undergo the Stupp treatment
Key inclusion criteria (10 listed)
- 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:
- Patients who undergo surgery with the possibility to collect samples from different regions of the tumor
Key exclusion criteria (8 listed)
- Patient with congestive heart failure within 6 months prior to study entry (New York Heart Association >= Grade 3)
- Uncontrolled or significant cardiovascular disease, including:
- 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
Overall Survival (OS)
Time frame: From date of inclusion (date of first MRI) until the date of death, assessed up to 48 months
Overall Survival is defined as the time from the first presurgical MRI is taken to the patient (MR0) to death
1 secondary outcome
Progression Free Survival (PFS)
Time frame: From date of inclusion (date of first MRI) until the date of documented tumor progression, assessed up to 48 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Astrocytoma, Grade IV, 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 10 inclusion and 8 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?
Overall Survival (OS) (time frame: From date of inclusion (date of first MRI) until the date of death, assessed up to 48 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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; AzTrials last refreshed its copy on 26 Oct 2026.