Clinical trial NCT03577600: Compassionate Treatment in Children With Brain Tumors With the Cytotron®
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).
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Pediatric Brain Tumor
Keywords: Recurrent Ependymoma
Brainstem Gliomas
Rotational Field Quantum Magnetic Resonance (RFQMR)
Cytotron®
High Grade Gliomas
Quantum Magnetic Resonance Therapy (QMRT)
Brain Tumor Recurrence
Lead sponsor: Hospital Infantil de Mexico Federico Gomez
Sponsor class: OTHER
First posted: 2018-07-05
Enrollment: 0
Sex: ALL
Minimum age (years): 3
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A case-study study. The controls will be historical and 2 controls will be taken that will be matched to the age range (preschool, school age, early adolescent, late adolescent), type of tumor and location (infra or supratentorial). 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 recruitment will be carried out with a sample at convenience in patients with brain tumors in terminal phase that are outside conventional treatment. The therapy with quantum magnetic resonance (Cytotron®) will be administered as a compassionate treatment with the authorization signed by the parents and with the respective informed consent (depending on age).
Primary purpose: TREATMENT

Brief 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.

Detailed 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

Eligibility criteria: 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.

Primary outcomes:
measure: Quality of life with the Pediatric Quality of Life Inventory (PedsQL) brain tumors
timeFrame: 6 months
Secondary outcomes:
measure: Measuring the increase, decrease, or change in the use of medication use for seizure or spasticity
timeFrame: 6 months
measure: Measuring the change in the number of seizures during the study period.
timeFrame: 6 months
measure: Change of brain activities using fMRI
timeFrame: 6 month
measure: Change of brain activities using the Diffusion tensor imaging in MRI
timeFrame: 6 month
measure: Change of brain activities using the EEG.
timeFrame: 6 month
Other outcomes:
Locations:
city: Ciudad de México
country: Mexico
facility: Hospital infantil de México Federico Gomez
state: DF
Study officials:
affiliation: Hospital Infantil de Mexico Federico Gomez
name: Juan C García Beristain, MD
role: STUDY_DIRECTOR
References:
citation: Barragan-Perez EJ, Alvarez-Amado DE, Dies-Suarez P, Tobon SH, Garcia-Beristain JC, Penaloza-Gonzalez JG. Compassionate use of Quantum Magnetic Resonance Therapy for treatment of children with Diffuse Brainstem Glioma in Mexico City: a single institutional experience. J Neurooncol. 2022 Apr;157(2):377-382. doi: 10.1007/s11060-022-03972-2. Epub 2022 Mar 10.