Study in Children With Brain Tumors in Terminal Stages Using Advanced Functional Magnetic Resonance Imaging in a Compassionate Palliative Care Setting, With Quantum Magnetic Resonance Therapy (QMRT).
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Quality of life with the Pediatric Quality of Life Inventory (PedsQL) brain tumors
研究概览
简要总结
This is a prospective case-control study. This study is expected to last for approximately 12 months, comprised of 4-8 weeks of enrollment period, 28 days of treatment and 6 months of follow up. The enrollment will be completed prior to the beginning of initial treatment. The study will be closed when 10 subjects have completed the study. The recruitment will be carried out with a sample at convenience.
详细描述
A case-study study. The controls will be historical and matched to the age range (preschool, school age, early adolescent, late adolescent) and type of tumor. This study is expected to last for approximately 12 months, comprised of 4-8 weeks of enrollment period, 28 days of treatment and 6 months of follow up. The recruitment will be carried out with a sample at convenience in patients with brain tumors in terminal phase that are outside conventional treatment. Quantum magnetic resonance therapy (QMRT) will be administrated with the Cytotron® device.. The CYTOTRON-RTE-6040-864GEN (Class IIA Medical Therapeutic Device; developed by Scalene Cybernetics Ltd, Bengaluru, India), is a patented (U.S. Patent 9162076 B2 awarded 20/10 2015, European Patent EP 175350831, awarded 3/11/2015, Chinese Patent issued 2010, 09/08), CE marked device. QMRT will be administered as a compassionate treatment with the authorization signed by the parent(s) and with the respective informed consent (depending on age). Study Center: Hospital Infantil de México Federico Gómez. Objectives: To determine the safety and efficacy of QMRT using the Cytotron in terminal brain tumors. Number of Subjects: 10. Diagnosis and main Inclusion Criteria Subjects with clinically diagnosed terminal brain tumors, age: 3 to 16. Study Device, Dose,Route Device: Cytotron-generated precisely computed, individualized Dosimetry with Radiofrequencies (RF) in the presence of a pulsed, instantaneous electromagnetic resonance (MR) field, applied to a subject. Dose: 1 hour per day. Route: Focused, non-invasive RF and MR beams delivered to target areas identified by brain MRI scan and individual proton density (PD) measurements of the target lesions. Duration of administration: Once a day for 28 consecutive days. Reference therapy: None
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
- 3 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A child 3 to 16 years of age.
- •A clinical diagnosis of terminal primary brain tumor
- •A diagnosis of a terminal brain tumor, which indicates that the patient is out of conventional treatment and does not have another therapeutic option.
排除标准
- •Patients with metastasis
- •Patients requiring oxygen or mechanical ventilation
- •Current or recent history (within 2 months) of significant bacterial, fungal, viral, or mycobacterial infection.
- •Having a condition considered as causing or likely to cause co-morbidities, as determined by the investigator based on medical history, physical examination, vital signs, and clinical laboratory tests.
- •Subject with magnetic implants, pacemakers, claustrophobia or any other condition that precludes them from entering or staying in the treatment device.
- •Children with previous neurosurgery within 6 months at the time of screening.
- •History of myocardial infarction, congestive heart failure, or stroke.
- •Subject is exposed to secondary smoking in his/her home environment.
- •Subjects who are unable or unlikely to comply with the protocol, determined by the majority vote of the investigators.
研究组 & 干预措施
QMRT using the Cytotron®
Experimental: QMRT using the Cytotron® Intervention: 28 days of treatment with QMRT with the Cytotron®. Patients diagnosed with terminal brain tumors between 3 and 16 years of age whose parents agree to participate in the study and have signed informed consent and informed consent in patients with age or mental age over 8 years.
干预措施: QMRT with the Cytotron® (Procedure)
结局指标
主要结局
Quality of life with the Pediatric Quality of Life Inventory (PedsQL) brain tumors
时间窗: 6 months
Change in the total score in the PedsQL of the patients diagnosed with brain tumor will be measured before starting the treatment and 6 months later. Higher values are going to represent a better outcome.
次要结局
- Measuring the increase, decrease, or change in the use of medication use for seizure or spasticity(6 months)
- Measuring the change in the number of seizures during the study period.(6 months)
- Change of brain activities using fMRI(6 month)
- Change of brain activities using the Diffusion tensor imaging in MRI(6 month)
- Change of brain activities using the EEG.(6 month)
研究者
Eduardo Javier Barragán Pérez
Chief of Neurology Department
Hospital Infantil de Mexico Federico Gomez