Recruiting NA Glioblastoma Multiforme

New treatment option for Glioblastoma Multiforme

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

ClinicalTrials.gov ID: NCT06533163

What this study is testing

What it's testing
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.
  • Which group you join is decided by chance.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older

You may be able to join if

  • The subject is at least 18 years of age.
  • The subject previously had maximal safe resection (MSR) for glioblastoma (GBM) per the discretion of the investigator and is able to receive standard...
  • The subject has a newly confirmed diagnosis of GBM per WHO classification criteria.
  • The subject has pre-op, post-surgical MRI and RX planning MRI scans available for Investigator review.
  • The subject has a confirmed unmethylated MGMT promoter status.

You likely can't join if

  • The subject has a tumor in the brainstem, extensive or multicentric disease (e.g. in both hemispheres), or an abnormal regrowth pattern between the...
  • The subject is any of the following: pregnant, planning on becoming pregnant during the investigation, breastfeeding, incarcerated, or enrolled in...
  • The subject has a severe acute infection, any autoimmune disease, significant congenital anomaly, other co-morbidity, or medical problem or is taking...
  • The subject has had a known focal or generalized seizure after surgery.
  • The subject has implants or any condition preventing the patient from undergoing serial MRI scans.
  • The patient has a skull defect (such as, missing bone with no replacement), bullet fragments or ferrous metals.
See the full eligibility criteria
Who can join
  • The subject is at least 18 years of age.
  • 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)
  • The subject has a newly confirmed diagnosis of GBM per WHO classification criteria.
  • The subject has pre-op, post-surgical MRI and RX planning MRI scans available for Investigator review.
  • The subject has a confirmed unmethylated MGMT promoter status.
  • The subject has a KPS ≥ 70.
  • The subject's life expectancy is \>12 weeks.
  • The subject is no longer taking corticosteroids.
  • The subject has signed and dated the consent form.
  • The subject has stated understanding and willingness to comply with all clinical investigation procedures and availability for the duration of the clinical investigation.
What rules you out
  • 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...
  • The subject is any of the following: pregnant, planning on becoming pregnant during the investigation, breastfeeding, incarcerated, or enrolled in another clinical investigation.
  • 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...
  • The subject has had a known focal or generalized seizure after surgery.
  • The subject has implants or any condition preventing the patient from undergoing serial MRI scans.
  • The patient has a skull defect (such as, missing bone with no replacement), bullet fragments or ferrous metals.
  • The subject has an active implanted device (e.g., cardiac pacemakers, Vagus Nerve Stimulation [VNS], Deep Brain Stimulation [DBS], programmable shunts, etc.).
  • 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.
  • The subject has a history of any previous anti-tumor treatment for a brain tumor.
  • 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).
  • 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...
  • The subject has planned concomitant or adjuvant chemotherapy.

The study team makes the final eligibility decision.

Where it's taking place

  • Stuttgart, Baden-Wurttemberg, Germany
  • München, Bavaria, Germany
  • Bonn, North Rhine-Westphalia, Germany
  • Lünen, North Rhine-Westphalia, Germany
  • Leipzig, Saxony, Germany
  • Mannheim, Germany

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Stuttgart, Baden-Wurttemberg, Germany; München, Bavaria, Germany; Bonn, North Rhine-Westphalia, Germany; Lünen, North Rhine-Westphalia, Germany; Leipzig, Saxony, Germany; Mannheim, Germany. Enter your location above to see the nearest site and check your eligibility.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.