Compassionate Treatment in Children With Brain Tumors With the Cytotron®

NCT03577600 | Withdrawn

• 1 other identifier: HIM 2018-007
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

Study Arms (1)

QMRT using the Cytotron®

EXPERIMENTAL

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.

Procedure: QMRT with the Cytotron®

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.

Also known as: Rotational Field Quantum Magnetic Resonance (RFQMR) Technology platform

QMRT using the Cytotron®

Eligibility Criteria

• Age: 3 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Infantil de Mexico Federico Gomez: lead

Study Sites (1)

Hospital infantil de México Federico Gomez

Mexico City, Mexico City, 06720, Mexico

Location

Related Publications (1)

• 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.

  PMID: 35266065 DERIVED

MeSH Terms

Conditions

Ependymoma

Condition Hierarchy (Ancestors)

Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Juan C García Beristain, MD

  Hospital Infantil de Mexico Federico Gomez

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Neurology Department

Model Details: 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).

Study Record Dates

• First Submitted: June 12, 2018
• First Posted: July 5, 2018
• Study Start: October 17, 2018
• Primary Completion: December 31, 2019
• Study Completion: July 31, 2020
• Last Updated: September 24, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)