Status:
RECRUITING
Combined Treatment of Patients With Newly Diagnosed Glioblastoma Using the Xoft® Axxent® Electronic Brachytherapy (eBx®) System for Intraoperative Balloon Electronic Brachytherapy
Lead Sponsor:
Joint Stock Company European Medical Centre
Conditions:
Glioblastoma
Eligibility:
All Genders
40-75 years
Phase:
PHASE1
Brief Summary
Glioblastoma is the most aggressive primary brain tumor due to its highly infiltrative growth pattern, strong proliferative potential, and multiple mechanisms of resistance to treatment . Based on res...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2029
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT07141732
Start Date
September 1 2025
End Date
March 1 2029
Last Update
September 16 2025
Active Locations (1)
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1
Joint-Stock Company European Medical Center
Moscow, Moscow, Russia, 129090