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 @ 4:22 AM
Ignite Modification Date:
2025-12-25 @ 4:22 AM
NCT ID:
NCT07042620
Eligibility Criteria:
Key Inclusion Criteria:
* A diffuse malignant glial tumour (high grade (grade III and IV) or low grade (grade I-II)) is suspected from the diagnostic MRI scan
* Pre- or peri-procedural confirmed histopathology of glioma
* ≥18 years of age
* Karnofsky performance status ≥ 70
* Life expectancy of more than 30 days at the time of procedure
* Negative pregnancy test for female subjects of childbearing potential
Key Exclusion Criteria:
* Not able to give consent (e.g., severe cognitive impairment)
* History of brain radiation therapy
* Recent meningitis (within 6 months prior to screening visit)
* Other active infection (within 30 days prior to screening visit)
* Immuno-incompetent patient (e.g., failing immune system due to AIDS)
* Patients taking immune-suppressive medication
* Intended biopsy only (meaning cases not suitable for resection)
* Known hypersensitivity to egg protein
* Known hypersensitivity to soybean or peanut protein
* Known Hypersensitivity to glycerol
* Pregnant or lactating females or females who intend to become pregnant during the time of the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07042620
Study Brief:
Protocol Section:
NCT07042620