Actively Recruiting
Low-Intensity Oscillatory Magnetic Therapy in Patients With Newly Diagnosed Glioblastoma Multiforme GBM - An Exposure-time Escalation Pilot Trial
Led by BioTex, Inc. · Updated on 2026-06-02
30
Participants Needed
6
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and performance of the Oncomagnetic Device, a portable wearable noninvasive magnetic device, in patients newly diagnosed with Glioblastoma Multiforme GBM. This non-randomized, multicenter, open-label clinical investigation uses an exposure-time escalation approach to understand how the device works over increasing durations of daily use. The study aims to provide important information on the devices clinical safety and effectiveness in this patient population. Participants will start using the Oncomagnetic Device for 4 hours per day. If no issues arise after 2 weeks, the daily use will increase to 6 hours, then to 8 hours after another 2 weeks without problems. If any device-related issues occur, the usage time may be reduced by 4 hours per day, with a minimum use of 2 hours daily, adjusted as needed. This personalized escalation continues throughout the study. During the study, participants will be monitored for safety and device performance for at least 6 months, with some evaluations extending up to 3 years. Assessments include clinical reviews and MRI scans to track disease status and any side effects. The main outcome is to assess safety within 6 months, while secondary outcomes focus on device performance over 6 months and up to 3 years. Participants must comply with all procedures and be available for the duration of the investigation.
CONDITIONS
Brief Title
Low-Intensity Oscillatory Magnetic Therapy in Patients With Newly Diagnosed Glioblastoma Multiforme (GBM) - An Exposure-time Escalation Pilot Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 18 years of age
- Previously had maximal safe resection surgery for glioblastoma per investigator discretion
- Newly confirmed diagnosis of glioblastoma multiforme according to WHO criteria
- Availability of pre-op, post-surgical MRI and radiation planning MRI scans for review
- Confirmed unmethylated MGMT promoter status
- Karnofsky Performance Status (KPS) score of 70 or higher
- Life expectancy greater than 12 weeks
- No longer taking corticosteroids
- Signed and dated informed consent form
- Willingness to comply with all study procedures and availability for the study duration
You will not qualify if you...
- Tumor in the brainstem, extensive or multicentric disease, or abnormal tumor regrowth between postoperative and radiation planning MRIs
- Pregnant, planning pregnancy during the study, breastfeeding, incarcerated, or enrolled in another clinical trial
- Severe acute infection, autoimmune disease, significant congenital anomaly, other serious medical problems, or recent immunosuppressant therapy (except dexamethasone)
- History of focal or generalized seizures after surgery
- Implants or conditions preventing serial MRI scans
- Skull defects, bullet fragments, or presence of ferrous metals
- Active implanted devices such as pacemakers or deep brain stimulators
- Low absolute neutrophil count (ANC < 1500 cells/mm3) or low platelet count (platelets < 100,000 cells/mm3)
- Previous anti-tumor treatment for a brain tumor
- Current or prior treatment with investigational agents or devices that may affect study results
- Use of nutritional supplements or alternative medicines that may affect study results, especially antioxidants
- Planned concomitant or adjuvant chemotherapy
Research Team
A
Ashok Gowda
M
Madeline Meier
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