Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:36 AM
Ignite Modification Date:
2025-12-25 @ 4:36 AM
NCT ID:
NCT05375318
Eligibility Criteria:
Inclusion Criteria:
Patients diagnosed with Astrocitoma, Grade 4, cIMPACT-NOW: update 6 classification with histopathological/genetic confirmation who undergo the Stupp treatment
* Age \> 18 years at diagnosis
* Patients with access to complete pre-operative MRI studies, including:
* Pre gadolinium T1-weighted MRI
* Post gadolinium T1-wighted MRI
* T2-weighted MRI
* T2-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:
6
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05375318
Study Brief:
Protocol Section:
NCT05375318