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).

Status Withdrawn

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.

Clinical Trial 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 ;

Related Conditions & MeSH terms

• Brain Neoplasms
• Pediatric Brain Tumor

• NCT number: NCT03577600
• Study type: Interventional
• Source: Hospital Infantil de Mexico Federico Gomez
• Status: Withdrawn
• Phase: N/A
• Start date: October 17, 2018
• Completion date: July 31, 2020