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

Not Applicable

Recruiting

• Conditions: Glioblastoma Multiforme
• Interventions: Device: Oncomagnetic device

• Registration Number: NCT06533163
• Lead Sponsor: BioTex, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-05-15
• Study First Submitted QC: 2024-07-31
• Status Verified: 2024-08
• Study First Posted: 2024-08-01
• Study Start: 2025-02-17
• Last Update Submitted: 2025-03-31
• Last Update Posted: 2025-04-03
• Primary Completion: 2027-11
• Study Completion: 2027-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. The subject is at least 18 years of age.
2. The subject previously had maximal safe resection (MSR) for glioblastoma (GBM) 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 both 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 < 1000 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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Device use	Oncomagnetic device	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 for 2 hours daily during the first two weeks. After this period, the duration will increase to 4 hours per day for the next two weeks, eventually reaching a maximum of 6 hours per day. 6 hours will then be used for the remainder of the time until the device is no longer required for use per protocol requirements. Dose adjustments may also be made based on MRI findings, specifically addressing swelling, pseudoprogression, imaging criteria violations, and other special cases; however, Investigators are encouraged to guide patients back to the optimal 6-hour duration, considering safety and tolerability. It is anticipated that some patients will require less than 6 hours of treatment on a long-term basis. Consultation with the PI should occur in such cases.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
To evaluate the performance of the Oncomagnetic Device in patients with newly diagnosed GBM.	6 months	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.

Trial Locations

Locations (1)

Universitätsklinikum Mannheim; 🇩🇪 Mannheim, Germany