Low-Intensity Oscillatory Magnetic Therapy in Patients With Newly Diagnosed Glioblastoma Multiforme (GBM) - An Exposure-time Escalation Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- BioTex, Inc.
- 入组人数
- 30
- 试验地点
- 12
- 主要终点
- To assess the safety of the Oncomagnetic device.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 ≥
- •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.
排除标准
- •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.
- •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 anticipated device use for a condition that in the opinion of the Investigator and Sponsor precludes enrollment in the investigation.
- •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/mm
- •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 properties is strongly discouraged).
- •The subject has planned concomitant or adjuvant chemotherapy.
研究组 & 干预措施
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 starting at 4 hours per day. If a patient doesn't experience any issues for 2 weeks, they would ramp up to 6 hours per day. After another 2 weeks without issues, they will increase to 8 hours per day and maintain that for the remainder of the study.
If a patient encounters any issues thought to probably be device related by the PI during any of the 2-week intervals at different doses, they will be reduced by 4 hours per day (with a minimum therapy of 2 hours per day) for a specified duration up to 2 weeks, although this can be adjusted based on symptoms at the investigator's discretion. Each patient will follow this personalized escalation pathway.
干预措施: Oncomagnetic device (Device)
结局指标
主要结局
To assess the safety of the Oncomagnetic device.
时间窗: 6 months
• Incidence of device-related adverse events (as per CTCAE v.5) at 6 months following surgery.
次要结局
- To evaluate the performance of the Oncomagnetic Device in patients with newly diagnosed GBM.(6 months)
- To evaluate the performance of the Oncomagnetic Device in patients with newly diagnosed GBM.(6 months)