Clinical trial · Observational
ALBATROSS Study: International Multicenter Study for Prospective Validation of Imaging Biomarkers Calculated at Vascular Habitats of High-grade Gliomas
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Astrocytoma, Grade IV | Astrocytoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Overall Survival (OS)
- timeFrame
- From date of inclusion (date of first MRI) until the date of death, assessed up to 48 months
- description
- Overall Survival is defined as the time from the first presurgical MRI is taken to the patient (MR0) to death
Secondary outcomes (1)
- measure
- Progression Free Survival (PFS)
- timeFrame
- From date of inclusion (date of first MRI) until the date of documented tumor progression, assessed up to 48 months
- description
- Progression Free Survival is defined as the time from the first presurgical MRI is taken to the patient to the detection of tumor relapse
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available