Status:
COMPLETED
ALBATROSS Study: International Multicenter Study for Prospective Validation of Imaging Biomarkers Calculated at Vascular Habitats of High-grade Gliomas
Lead Sponsor:
Juan M Garcia-Gomez
Collaborating Sponsors:
Oslo University Hospital
Azienda Ospedaliero-Universitaria di Parma
Conditions:
Astrocytoma, Grade IV
Eligibility:
All Genders
18+ years
Brief 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. The pro...
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 rel...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2023
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT05229198
Start Date
June 1 2020
End Date
June 1 2023
Last Update
July 8 2025
Active Locations (1)
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1
Universitat Politècnica de València
Valencia, Valencia, Spain, 46021