ALBATROSS Study: International Multicenter Study for Prospective Validation of Imaging Biomarkers… (NCT05229198) | Clinical Trial Compass
CompletedNot Applicable
ALBATROSS Study: International Multicenter Study for Prospective Validation of Imaging Biomarkers Calculated at Vascular Habitats of High-grade Gliomas
Spain300 participantsStarted 2020-06-01
Plain-language 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 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.
Who can participate
Age range18 Years
SexALL
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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
What they're measuring
1
Overall Survival (OS)
Timeframe: From date of inclusion (date of first MRI) until the date of death, assessed up to 48 months