Using low-intensity magnetic therapy for newly diagnosed glioblastoma patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical investigation is a non-randomized, multicenter, open-label pilot trial designed to evaluate the safety and effectiveness of the Oncomagnetic Device in patients with newly diagnosed glioblastoma multiforme (GBM). The study will involve an exposure-time escalation approach, where patients will receive varying durations of treatment to assess the device's performance. Participants must have undergone maximal safe resection and have a confirmed diagnosis of GBM, along with specific eligibility criteria related to their health status and treatment history.

Why it matters

Who can join: the full rules

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:

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.

Where it's running

• Clinical Center Stuttgart
  Stuttgart, Baden-Wurttemberg, Germany Recruiting
• Technical University of Munich
  München, Bavaria, Germany Recruiting
• University Hospital Bonn
  Bonn, North Rhine-Westphalia, Germany Recruiting
• Clinical Center Lünen
  Lünen, North Rhine-Westphalia, Germany Recruiting
• University Hospital Leipzig
  Leipzig, Saxony, Germany Recruiting
• Medical Center Mannheim
  Mannheim, Germany Recruiting

Study contacts

• Principal investigator: Frank Giordano, MD — Universitätsmedizin Mannheim | UMM
• Study coordinator: Ashok Gowda
• Email: ashok@biotexmedical.com
• Phone: 713-741-0111

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.