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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. The subject previously had maximal safe resection (MSR) for glioblastoma (GBM). 2. The subject is at least 18 years of age. 3. The subject has a newly confirmed diagnosis of GBM per WHO classification criteria. MGMT unmethylated tumors only shall be included. 4. The subject has a post-surgical MRI scan available for Investigator review. 5. The subject has a KPS ≥ 70. 6. The subject's life expectancy is >12 weeks. 7. The subject is either no longer taking corticosteroids or is in the process of tapering down to a maximum dose of 4 mg per day. 8. The subject has signed and dated the consent form. 9. 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 leptomeningeal disease or multicentric disease (e.g. in both hemispheres). 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 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 implants or any condition preventing the patient from undergoing serial MRI scans. 5. 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.

6. The subject has a history of any previous anti-tumor treatment for a brain tumor. 7. 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). 8. The subject takes any nutritional supplements or alternative medical treatments that may compromise the results of this investigation (as per discretion of the Investigator).

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06533163
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	BioTex, Inc.
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Frank Giordano, MD
Principal Investigator Affiliation	Universitätsmedizin Mannheim \| UMM
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Not yet recruiting
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Glioblastoma Multiforme

Arms & Interventions

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 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.

Interventions

Device: - Oncomagnetic device

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

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

BRITNEE OCHABSKI

[email protected]

713-741-0111

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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