Low-Intensity Oscillatory Magnetic Therapy in Patients With Newly Diagnosed Glioblastoma Multiforme (GBM) - An Exposure-time Escalation Pilot Trial (OMX-EFS-01)

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.

Study Overview

• Status: Recruiting
• Conditions: Glioblastoma Multiforme
• Intervention / Treatment: Device: Oncomagnetic device

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Madeline Meier; Phone Number: 254 713-741-0111; Email: madeline.meier@biotexmedical.com
• Study Contact Backup: Name: Ashok Gowda; Phone Number: 201 713-741-0111; Email: ashok@biotexmedical.com

Study Locations

• Germany
  • Mannheim, Germany, 68167
    • Recruiting
    • Medical Center Mannheim
    • Contact: Frank Giordano; Phone Number: 0049 6213 8315 0049; Email: frank.giordano@umm.de
  • Baden-Wurttemberg
    • Stuttgart, Baden-Wurttemberg, Germany, 70174
      • Recruiting
      • Clinical Center Stuttgart
      • Contact: Marc Muenter; Phone Number: 0049 0711/278 33701; Email: M.Muenter@klinikum-stuttgart.de
  • Bavaria
    • München, Bavaria, Germany, 81675
      • Recruiting
      • Technical University of Munich
      • Contact: Stephanie Combs; Phone Number: 0049 894-140-4500; Email: stephanie.combs@tum.de
  • North Rhine-Westphalia
    • Bonn, North Rhine-Westphalia, Germany, 53127
      • Recruiting
      • University Hospital Bonn
      • Contact: Eleni Gkika; Phone Number: 0049 2282 8710 352; Email: Eleni.Gkika@ukbonn.de
    • Lünen, North Rhine-Westphalia, Germany, 44534
      • Recruiting
      • Clinical Center Lünen
      • Contact: Martin Glas; Phone Number: 0049 201 7236507; Email: Martin.Glas@uk-essen.de
  • Saxony
    • Leipzig, Saxony, Germany, 04103
      • Recruiting
      • University Hospital Leipzig
      • Contact: Clemens Seidel; Phone Number: 0049 341 9718400; Email: Clemens.Seidel@medizin.uni-leipzig.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. The subject is at least 18 years of age.
2. 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)
3. The subject has a newly confirmed diagnosis of GBM per WHO classification criteria.
4. The subject has pre-op, post-surgical MRI and RX planning MRI scans available for Investigator review.
5. The subject has a confirmed unmethylated MGMT promoter status.
6. The subject has a KPS ≥ 70.
7. The subject's life expectancy is >12 weeks.
8. The subject is no longer taking corticosteroids.
9. The subject has signed and dated the consent form.
10. The subject has stated understanding and willingness to comply with all clinical investigation procedures and availability for the duration of the clinical investigation.

Exclusion Criteria:

1. 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.
2. The subject is any of the following: pregnant, planning on becoming pregnant during the investigation, breastfeeding, incarcerated, or enrolled in another clinical investigation.
3. 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.
4. The subject has had a known focal or generalized seizure after surgery.
5. The subject has implants or any condition preventing the patient from undergoing serial MRI scans.
6. The patient has a skull defect (such as, missing bone with no replacement), bullet fragments or ferrous metals.
7. The subject has an active implanted device (e.g., cardiac pacemakers, Vagus Nerve Stimulation [VNS], Deep Brain Stimulation [DBS], programmable shunts, etc.).

8. The subject has any of the following lab results:

   • ANC < 1500 cells/mm3 or < 1.5 x 10^9 /L.
   • Platelet count < 100,000 cells/mm3.
9. The subject has a history of any previous anti-tumor treatment for a brain tumor.
10. The subject is currently being treated or has been treated with other investigational agents/devices that may compromise the results of this investigation (as per discretion of the Investigator).
11. The subject takes any nutritional supplements or alternative medical treatments that may compromise the results of this investigation (this is as per discretion of the Investigator, but any compound with anti-oxidant properties is strongly discouraged).
12. The subject has planned concomitant or adjuvant chemotherapy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Device use; This investigation will employ an individualized dose-time-escalation approach starting each patient at a low dose and escalating the dose within the same patient. For each patient, the device will be used starting at 4 hours per day. If a patient doesn't experience any issues for 2 weeks, they would ramp up to 6 hours per day. After another 2 weeks without issues, they will increase to 8 hours per day and maintain that for the remainder of the study. If a patient encounters any issues thought to probably be device related by the PI during any of the 2-week intervals at different doses, they will be reduced by 4 hours per day (with a minimum therapy of 2 hours per day) for a specified duration up to 2 weeks, although this can be adjusted based on symptoms at the investigator's discretion. Each patient will follow this personalized escalation pathway.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess the safety of the Oncomagnetic device.	• Incidence of device-related adverse events (as per CTCAE v.5) at 6 months following surgery.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the performance of the Oncomagnetic Device in patients with newly diagnosed GBM.	Response of Index Lesion: • Via radiographic assessment (MRI)	6 months
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.	6 months
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.	3 years
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.	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess imaging data for exploratory analyses and to support potential future research endeavors.	• Via radiographic assessment (MRI)	3 years
To identify biomarkers that correlate with outcome.	Via blood biomarker collection	3 years

Collaborators and Investigators

• Sponsor: BioTex, Inc.
• Investigators: Principal Investigator: Frank Giordano, MD, Universitätsmedizin Mannheim | UMM

Study record dates

Study Major Dates

• Study Start (Actual): February 17, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): April 1, 2028

Study Registration Dates

• First Submitted: May 15, 2024
• First Submitted That Met QC Criteria: July 31, 2024
• First Posted (Actual): August 1, 2024

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: May 29, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioblastoma
• Other Study ID Numbers: OMX-EFS-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be shared via Clinical Trial Journal
• IPD Sharing Time Frame: After Study Completion
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes