Brain cancer breakthrough? new device zaps tumors during surgery
NCT ID NCT07141732
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This early-phase trial tests a new approach for glioblastoma, an aggressive brain cancer. During surgery to remove the tumor, doctors will use a special balloon device to deliver a single dose of radiation directly to the area. Afterward, patients will receive standard chemotherapy and radiation. The goal is to see if this combination can help people live longer. Only 15 people will take part in this pilot study.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Xoft Axxent eBx System (electronic brachytherapy device)
- What this could lead to
- If successful, this approach could improve survival for glioblastoma patients by delivering radiation directly to the tumor site during surgery, potentially reducing recurrence.
- What could go wrong
- This is a very early phase 1 trial with only 15 people, so results may not apply broadly. Risks include radiation damage to healthy brain tissue, infection, or no benefit over standard care.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 15 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2025
- Expected to finish
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Mar 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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40 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Joint-Stock Company European Medical Center
RECRUITINGMoscow, Moscow, 129090, Russia
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