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RecruitingNCT06533163OMX-EFS-01Updated Jun 2, 2026

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

An interventional study of Oncomagnetic device in Glioblastoma Multiforme, sponsored by BioTex, Inc.. Recruiting at 6 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-02.

Sponsored by BioTex, Inc. · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Feb 2025; still recruiting 1 year 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Glioblastoma Multiforme

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03

In context

Glioblastoma

1,920 studies on the registry are indexed under Glioblastoma; 450 are open to participants now.

This study's planned enrollment of 30 is below the median of 36 across 1,618 interventional studies indexed under Glioblastoma.

Browse Glioblastoma studies →

Lead sponsor

BioTex, Inc. is the lead sponsor of 5 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • 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

Interventions

  • DeviceOncomagnetic device

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

06

What researchers measure

Primary outcomes

  1. To assess the safety of the Oncomagnetic device.

    • Incidence of device-related adverse events (as per CTCAE v.5) at 6 months following surgery.

    Time frame: 6 months

Secondary outcomes

  1. To evaluate the performance of the Oncomagnetic Device in patients with newly diagnosed GBM.

    Response of Index Lesion: • Via radiographic assessment (MRI)

    Time frame: 6 months

  2. 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.

    Time frame: 6 months

  3. 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.

    Time frame: 3 years

  4. 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.

    Time frame: 6 months

Other outcomes

  1. To assess imaging data for exploratory analyses and to support potential future research endeavors.

    • Via radiographic assessment (MRI)

    Time frame: 3 years

  2. To identify biomarkers that correlate with outcome.

    Via blood biomarker collection

    Time frame: 3 years

07

Study locations

6 of 6 sites recruiting
  • Clinical Center Stuttgart
    Stuttgart, Baden-Wurttemberg 70174, Germany
    Recruiting
  • Technical University of Munich
    München, Bavaria 81675, Germany
    Recruiting
  • University Hospital Bonn
    Bonn, North Rhine-Westphalia 53127, Germany
    Recruiting
  • Clinical Center Lünen
    Lünen, North Rhine-Westphalia 44534, Germany
    Recruiting
  • University Hospital Leipzig
    Leipzig, Saxony 04103, Germany
    Recruiting
  • Medical Center Mannheim
    Mannheim, 68167, Germany
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes — Data will be shared via Clinical Trial Journal

Supporting information: Csr

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06533163
Lead sponsor
BioTex, Inc.
Responsible party
Sponsor
First posted
Aug 1, 2024
Start date
Feb 17, 2025
Primary completion
Nov 2027 (estimated)
Completion
Apr 2028 (estimated)
Last update
Jun 2, 2026

Study contacts

Ashok Gowda
Contact
ashok@biotexmedical.com
713-741-0111 ext. 201
Madeline Meier
Contact
madeline.meier@biotexmedical.com
713-741-0111 ext. 254
Frank Giordano, MD
principal investigator · Universitätsmedizin Mannheim | UMM

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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