Clinical trial NCT06533163: Low-Intensity Oscillatory Magnetic Therapy in Patients With Newly Diagnosed Glioblastoma Multiforme (GBM) - An Exposure-time Escalation Pilot Trial
Official title: Low-Intensity Oscillatory Magnetic Therapy in Patients With Newly Diagnosed Glioblastoma Multiforme (GBM) - An Exposure-time Escalation Pilot Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Glioblastoma Multiforme
Lead sponsor: BioTex, Inc.
Sponsor class: INDUSTRY
First posted: 2024-08-01
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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).

Primary outcomes:
measure: To assess the safety of the Oncomagnetic device.
timeFrame: 6 months
Secondary outcomes:
measure: To evaluate the performance of the Oncomagnetic Device in patients with newly diagnosed GBM.
timeFrame: 6 months
measure: To evaluate the performance of the Oncomagnetic Device in patients with newly diagnosed GBM.
timeFrame: 6 months
measure: To evaluate the performance of the Oncomagnetic Device in patients with newly diagnosed GBM.
timeFrame: 3 years
measure: To evaluate the performance of the Oncomagnetic Device in patients with newly diagnosed GBM.
timeFrame: 6 months
Other outcomes:
measure: To assess imaging data for exploratory analyses and to support potential future research endeavors.
timeFrame: 3 years
measure: To identify biomarkers that correlate with outcome.
timeFrame: 3 years
Locations:
city: Mannheim
country: Germany
facility: Universitätsklinikum Mannheim
Study officials:
affiliation: Universitätsmedizin Mannheim | UMM
name: Frank Giordano, MD
role: PRINCIPAL_INVESTIGATOR
References: