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.
The subject is at least 18 years of age.
The subject previously had maximal safe resection (MSR) for glioblastoma (GBM) per the discretion of the investigator and is able to receive standard radiotherapy (unless contraindicated or refused by the subject)
The subject has a newly confirmed diagnosis of GBM per WHO classification criteria.
The subject has pre-op, post-surgical MRI and RX planning MRI scans available for Investigator review.
The subject has a tumor in the brainstem, extensive or multicentric disease (e.g. in both hemispheres), or an abnormal regrowth pattern between the post operation MRI and RX planning MRI, suggesting early tumor progression, as determined by the Investigator's discretion.
The subject is any of the following: pregnant, planning on becoming pregnant during the investigation, breastfeeding, incarcerated, or enrolled in another clinical investigation.
The subject has a severe acute infection, any autoimmune disease, significant congenital anomaly, other co-morbidity, or medical problem or is taking immunosuppressant therapy (except Dexamethasone) within 90 days of anticipated device use for a condition that in the opinion of the Investigator and Sponsor precludes enrollment in the investigation.
The subject has had a known focal or generalized seizure after surgery.
Single group
Oncomagnetic device
DeviceOncoMAGNETX has developed a portable wearable noninvasive magnetic device (Oncomagnetic device) for the treatment of GBM.
To assess the safety of the Oncomagnetic device.
• Incidence of device-related adverse events (as per CTCAE v.5) at 6 months following surgery.
To evaluate the performance of the Oncomagnetic Device in patients with newly diagnosed GBM.
Response of Index Lesion: • Via radiographic assessment (MRI)
To evaluate the performance of the Oncomagnetic Device in patients with newly diagnosed GBM.
Median Progression-Free Survival at 6 months (PFS-6) following surgery: • Changes in tumor volume via radiographic assessment (MRI) analyzed via independent reviewer using mRANO criteria.
To evaluate the performance of the Oncomagnetic Device in patients with newly diagnosed GBM.
Median Overall Survival (OS): • Measured by the length of time from initial diagnosis until subject expiration.
To evaluate the performance of the Oncomagnetic Device in patients with newly diagnosed GBM.
Quality of Life (QOL): • Assessed using the validated quality of life scale (QLQ-C30) by the EORTC as well as the module for brain tumors, BN 20 and Barthel Index.
To assess imaging data for exploratory analyses and to support potential future research endeavors.
• Via radiographic assessment (MRI)
To identify biomarkers that correlate with outcome.
Via blood biomarker collection
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