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:
2025-12-24 @ 9:48 PM
Ignite Modification Date:
2025-12-24 @ 9:48 PM
NCT ID:
NCT07141732
Eligibility Criteria:
Inclusion Criteria:
* The subject's age must be ≥ 40 years but not older than 75 years.
* The subject's Karnofsky Performance Status (KPS) must be ≥ 70%.
* The subject is willing and able to independently provide informed consent for participation in the study.
* The subject has been newly diagnosed with glioblastoma (GB) based on preoperative neuroimaging (contrast-enhanced brain MRI ± amino acid-based PET/CT) and confirmed by intraoperative histopathological examination of the tumor.
* Total or near-total resection of the contrast-enhancing tumor portion is feasible.
* The expected post-resection cavity size must allow placement of the Axxent Xoft eBx balloon applicator system.
* Women of childbearing potential must have a negative pregnancy test within 7 days before treatment initiation.
* The subject must have a complete blood count (CBC) with or without differential within 7 days before study enrollment, demonstrating adequate bone marrow function:
* Absolute neutrophil count (ANC) ≥ 1500 cells/mm³
* Platelets ≥ 75,000 cells/mm³
* Hemoglobin ≥ 10.0 g/dL
* The subject must undergo kidney and liver function tests within 7 days before study enrollment, with the following required parameters:
* Total bilirubin ≤ 2.0 mg/dL, and AST ≤ 2.5 × upper limit of normal (ULN)
* Serum creatinine ≤ 1.8 mg/dL within 14 days before enrollment.
* The subject's urine protein levels must meet the following criteria within 14 days before enrollment:
* Urine protein-to-creatinine ratio (UPCR) \< 1.0, OR
* Dipstick urinalysis ≤ 2+ proteinuria (if \> 2+, a 24-hour urine collection must show ≤ 1 g protein/24h).
* Patients on anticoagulant therapy (e.g., warfarin or low-molecular-weight heparin) must meet all of the following:
* No active bleeding or high-risk bleeding conditions (e.g., tumor involving major vessels or varices).
* Stable INR (typically 2-3) on oral anticoagulants OR stable dose of LMWH for ≥ 14 days before enrollment.
Exclusion Criteria:
* Multicentric/multifocal glioblastoma growth.
* Infratentorial or leptomeningeal tumor spread.
* Recurrent/progressive glioblastoma.
* Prior cranial radiation therapy.
* Glioblastoma located in or near (≤ 10 mm from) critical brain structures, preventing adequate radiation dose delivery.
* Contrast-enhancing tumor diameter \> 6 cm.
* Active or prior malignancy (except adequately treated non-melanoma skin cancer or carcinoma in situ).
* Other intracranial neoplasms (current or history).
* Pregnancy, lactation, or unwillingness to use effective contraception (for women of childbearing potential or sexually active men).
* Contraindications to MRI (with or without gadolinium).
* Non-removable or clinically inoperable cardiac pacemaker/device.
* Contraindications to general anesthesia.
* Concurrent participation in another clinical trial.
* Severe comorbidities, including:
* Unstable angina or congestive heart failure requiring hospitalization (within 6 months).
* Transmural myocardial infarction (within 6 months).
* Stroke or transient ischemic attack (within 6 months).
* Significant vascular disease (aortic/peripheral).
* Active venous/arterial thromboembolism.
* Acute bacterial/fungal infection requiring IV antibiotics.
* COPD exacerbation or respiratory disease interfering with protocol therapy.
* Liver failure causing jaundice/coagulopathy.
* Positive serology for HIV, HBV, HCV, or syphilis.
* Grade ≥ 3 hemorrhage (CTCAE v5.0) within 30 days before enrollment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
75 Years
Study:
NCT07141732
Study Brief:
Protocol Section:
NCT07141732