Compassionate Treatment in Children With Brain Tumors With the Cytotron®

Hospital Infantil de Mexico Federico Gomez

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Conditions

Pediatric Brain Tumor

Interventions

QMRT with the Cytotron®PROCEDURE

Cytotron® utilizes a combination of instantaneous magnetic field and RF at the safe, lowerend of the EM spectrum. Radiofrequency waves are computed based on individualized PD measurements of the target lesion(s) for therapeutic purpose. Its working principle is based on the underlying theory of magnetic resonance.

Eligibility

Sex: ALLMin age: 3 YearsMax age: 16 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Locations (1)

Hospital infantil de México Federico Gomez

Mexico City, Mexico City, Mexico

Outcomes

Primary Outcomes

Quality of life with the Pediatric Quality of Life Inventory (PedsQL) brain tumors

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.

Time frame: 6 months

Secondary Outcomes

Measuring the increase, decrease, or change in the use of medication use for seizure or spasticity

The change in the use of medications use for seizure or spasticity as a symptom manifestation in children brain tumors before initiating the treatment and 6 months later will be measured.

Time frame: 6 months

Measuring the change in the number of seizures during the study period.

The change in the use of the number of epileptic seizures of the patients diagnosed with terminal brain tumor before initiating the treatment and 6 months later will be measured.

Time frame: 6 months

Change of brain activities using fMRI

Identifying the change in representative modules, visual, motor and basal ganglia measuring the brain activities during resting state before and after treatment.

Time frame: 6 month

Change of brain activities using the Diffusion tensor imaging in MRI

Identifying the change in representative modules, visual, motor and basal ganglia by measuring diffusion tensor data and the anisotropic diffusion of the brain before and after treatment.

Time frame: 6 month

Change of brain activities using the EEG.

Identifying the change in electrical activity in the brain before and after treatment.

Data from ClinicalTrials.gov

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