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 2025-07-14
40
Participants Needed
6
Research Sites
141 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The clinical investigation is a non-randomized, multicenter, open-label, prospective, exposure-time escalation clinical investigation. The clinical investigation is designed to assess the clinical safety and performance of the Oncomagnetic Device.
CONDITIONS
Official 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 for glioblastoma as determined by the investigator
- Newly confirmed diagnosis of glioblastoma multiforme per WHO classification
- Have pre-operative, post-surgical MRI and radiotherapy planning MRI scans available for review
- Confirmed unmethylated MGMT promoter status
- Karnofsky Performance Status (KPS) of 70 or higher
- Life expectancy greater than 12 weeks
- No longer taking corticosteroids
- Signed and dated informed consent form
- Willing and able to comply with all study procedures and be available for the study duration
You will not qualify if you...
- Tumor located in the brainstem, extensive or multicentric disease, or abnormal tumor regrowth pattern between post-op and planning MRI
- Pregnant, planning pregnancy during the study, breastfeeding, incarcerated, or enrolled in another clinical investigation
- Severe acute infection, autoimmune disease, significant congenital anomaly, other serious medical problems, or on immunosuppressant therapy (except Dexamethasone) within 90 days prior
- History of focal or generalized seizure after surgery
- Implants or conditions preventing serial MRI scans
- Skull defect (missing bone without replacement), bullet fragments, or ferrous metals
- Active implanted devices such as pacemakers, Vagus Nerve Stimulation, Deep Brain Stimulation, or programmable shunts
- Laboratory values: ANC less than 1000 cells/mm3 or platelet count less than 100,000 cells/mm3
- Previous anti-tumor treatment for a brain tumor
- Current or prior treatment with investigational agents/devices that may affect study results
- Use of nutritional supplements or alternative treatments with antioxidant properties that may affect study results
- Planned concomitant or adjuvant chemotherapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Clinical Center Stuttgart
Stuttgart, Baden-Wurttemberg, Germany, 70174
Actively Recruiting
2
Technical University of Munich
München, Bavaria, Germany, 81675
Actively Recruiting
3
University Hospital Bonn
Bonn, North Rhine-Westphalia, Germany, 53127
Actively Recruiting
4
Clinical Center Lünen
Lünen, North Rhine-Westphalia, Germany, 44534
Actively Recruiting
5
University Hospital Leipzig
Leipzig, Saxony, Germany, 04103
Actively Recruiting
6
Medical Center Mannheim
Mannheim, Germany, 68167
Actively Recruiting
Research Team
A
Ashok Gowda
CONTACT
M
Madeline Meier
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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