BIOhabitats: Biological Validation of Vascular Habitats Within Astrocytoma Grade 4 at Molecular, … (NCT05375318) | Clinical Trial Compass
CompletedNot Applicable
BIOhabitats: Biological Validation of Vascular Habitats Within Astrocytoma Grade 4 at Molecular, Cellular, and Histopathological Levels
Spain50 participantsStarted 2021-03-01
Plain-language summary
The main purposes of this study are:
I. To assess that the four habitats within the tumor (HAT and LAT) and edema (IPE and VPE) in high-grade glioma are different at vascular, tissular, cellular and molecular levels.
II. To analyze the associations between the perfusion imaging markers and relevant molecular markers at the HTS habitats for high-grade glioma diagnosis, prognosis/aggressiveness, progression and/or prediction.
III. To analyze the associations between the perfusion imaging markers and immune markers at the HTS habitats useful in immunotherapy evaluation and/or patient selection.
IV. To prospectively validate the prognostic capacity (association with OS and PFS) and stratification capacity of the perfusion imaging markers calculated at the HTS habitats.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Molecular profile of each vascular habitat biopsied for each included patient
Timeframe: through study completion, an average of 1 year
2
Description at cellular level of each vascular habitat biopsied for each included patient, including cell types and cell density
Timeframe: through study completion, an average of 1 year
3
Description at histopathological level of each vascular habitat biopsied for each included patient, including tissues, necrosis, vascularuture
Timeframe: through study completion, an average of 1 year