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Pediatric Brain TumorNCT03577600

Compassionate Treatment in Children With Brain Tumors With the Cytotron®

A study testing QMRT with the Cytotron® in people with Pediatric Brain Tumor, run by Hospital Infantil de Mexico Federico Gomez at 1 site in Mexico.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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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. Read more about this study

Who is it for?
Ages 3 to 16 years
Conditions the study is for
Pediatric Brain Tumor
What is being tested?
QMRT with the Cytotron®
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteMexico
Study dates
17 Oct 2018to 31 Jul 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 to 16 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 9Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Mexico1 site

  • Hospital infantil de México Federico Gomez

    Mexico City, Mexico City, 06720

Other trials in Mexico

About this study

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).

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.

Read the 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

Being tested
QMRT with the Cytotron®
Keywords
Recurrent Ependymoma, Brainstem Gliomas, Rotational Field Quantum Magnetic Resonance (RFQMR), Cytotron®, High Grade Gliomas, Quantum Magnetic Resonance Therapy (QMRT), Brain Tumor Recurrence
Medical subject headings
Ependymoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • QMRT with the Cytotron®Procedure or surgery

    Also called Rotational Field Quantum Magnetic Resonance (RFQMR) Technology platform

    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.

Study groups in NCT03577600
Study groupRoleWhat they receive
QMRT using the Cytotron®ExperimentalExperimental: 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.
Receives: Procedure: QMRT with the Cytotron®

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 6 months

Secondary outcomes (5)

  1. 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.

    Measured: 6 months

  2. 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.

    Measured: 6 months

  3. 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.

    Measured: 6 month

  4. 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.

    Measured: 6 month

  5. Change of brain activities using the EEG.

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

    Measured: 6 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jul 2018
  2. Study start17 Oct 2018
  3. Primary completion31 Dec 2019 (estimated)
  4. Study completion31 Jul 2020 (estimated)

Why it stopped: suspended due to administrative problems

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
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).
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03577600
Sponsor's protocol ID
HIM 2018-007
Status last verified
Sep 2019
First submitted
12 Jun 2018
Last updated
24 Sep 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 35266065

Questions about this trial

What is this clinical trial studying?

A study testing QMRT with the Cytotron® in people with Pediatric Brain Tumor, run by Hospital Infantil de Mexico Federico Gomez at 1 site in Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 24 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quality of life with the Pediatric Quality of Life Inventory (PedsQL) brain tumors (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03577600, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2019.

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