RecruitingNot ApplicableNCT06533163

Low-Intensity Oscillatory Magnetic Therapy in Patients With Newly Diagnosed Glioblastoma Multiforme (GBM) - An Exposure-time Escalation Pilot Trial


Sponsor

BioTex, Inc.

Enrollment

30 participants

Start Date

Feb 17, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This pilot study tests a wearable device that generates low-intensity oscillating magnetic fields as an add-on treatment for people with newly diagnosed glioblastoma (GBM) — a very aggressive type of brain tumor. The device is worn on the head and may interfere with tumor cell division. This study focuses specifically on patients whose tumor does not have a particular chemical marker (unmethylated MGMT) that typically makes standard treatment less effective, and tests different lengths of daily device use to find the safest exposure time. **You may be eligible if...** - You are 18 or older with a newly confirmed diagnosis of glioblastoma - You have had maximum safe surgical removal of your tumor - Your tumor has unmethylated MGMT status (a lab test result) - You are able to receive standard radiation therapy - You are in reasonably good health (Karnofsky score ≥70) - Your expected survival is more than 12 weeks - You are no longer taking steroids **You may NOT be eligible if...** - Your tumor is in the brainstem or in both brain hemispheres - Your scans suggest your tumor is already progressing rapidly after surgery - You are pregnant, breastfeeding, or planning to become pregnant - You have a seizure disorder (unless well controlled) - You have a severe infection, autoimmune disease, or significant other health problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEOncomagnetic device

OncoMAGNETX has developed a portable wearable noninvasive magnetic device (Oncomagnetic device) for the treatment of GBM.


Locations(6)

Clinical Center Stuttgart

Stuttgart, Baden-Wurttemberg, Germany

Technical University of Munich

München, Bavaria, Germany

University Hospital Bonn

Bonn, North Rhine-Westphalia, Germany

Clinical Center Lünen

Lünen, North Rhine-Westphalia, Germany

University Hospital Leipzig

Leipzig, Saxony, Germany

Medical Center Mannheim

Mannheim, Germany

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NCT06533163


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