Compassionate Treatment in Children With Brain Tumors With the Cytotron®

Pediatric Brain Tumor Clinical Trial

Official title:

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).

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03577600
• Other study ID #: HIM 2018-007
• Status: Withdrawn
• Phase: N/A
• Start date: October 17, 2018
• Est. completion date: July 31, 2020

Study information

• Verified date: September 2019
• Source: Hospital Infantil de Mexico Federico Gomez
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 31, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 16 Years

Eligibility

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.

Related Conditions & MeSH terms

• Brain Neoplasms
• Pediatric Brain Tumor

Intervention

Procedure:
• QMRT with the Cytotron®
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.

Locations

Country	Name	City	State
Mexico	Hospital infantil de México Federico Gomez	Ciudad de México	DF

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Infantil de Mexico Federico Gomez

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months
Secondary	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.	6 months
Secondary	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.	6 months
Secondary	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.	6 month
Secondary	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.	6 month
Secondary	Change of brain activities using the EEG.	Identifying the change in electrical activity in the brain before and after treatment.	6 month