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Trial Title:
Low-Intensity Oscillatory Magnetic Therapy in Patients With Newly Diagnosed Glioblastoma Multiforme (GBM) - An Exposure-time Escalation Pilot Trial
NCT ID:
NCT06533163
Condition:
Glioblastoma Multiforme
Conditions: Official terms:
Glioblastoma
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
Oncomagnetic device
Description:
OncoMAGNETX has developed a portable wearable noninvasive magnetic device (Oncomagnetic
device) for the treatment of GBM.
Arm group label:
Device use
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.
Criteria for eligibility:
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).
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
November 2024
Completion date:
November 2027
Lead sponsor:
Agency:
BioTex, Inc.
Agency class:
Industry
Source:
BioTex, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06533163
