Compassionate Treatment in Children With Brain Tumors With the Cytotron®
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|ClinicalTrials.gov Identifier: NCT03577600|
Recruitment Status : Withdrawn (suspended due to administrative problems)
First Posted : July 5, 2018
Last Update Posted : September 24, 2019
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|Condition or disease||Intervention/treatment||Phase|
|Pediatric Brain Tumor||Procedure: QMRT with the Cytotron®||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|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).|
|Masking:||None (Open Label)|
|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).|
|Actual Study Start Date :||October 17, 2018|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||July 31, 2020|
Experimental: QMRT using the Cytotron®
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®
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.
Other Name: Rotational Field Quantum Magnetic Resonance (RFQMR) Technology platform
- Quality of life with the Pediatric Quality of Life Inventory (PedsQL) brain tumors [ Time Frame: 6 months ]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.
- Measuring the increase, decrease, or change in the use of medication use for seizure or spasticity [ Time Frame: 6 months ]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.
- Measuring the change in the number of seizures during the study period. [ Time Frame: 6 months ]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.
- Change of brain activities using fMRI [ Time Frame: 6 month ]Identifying the change in representative modules, visual, motor and basal ganglia measuring the brain activities during resting state before and after treatment.
- Change of brain activities using the Diffusion tensor imaging in MRI [ Time Frame: 6 month ]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.
- Change of brain activities using the EEG. [ Time Frame: 6 month ]Identifying the change in electrical activity in the brain before and after treatment.
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|Ages Eligible for Study:||3 Years to 16 Years (Child)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03577600
|Hospital infantil de México Federico Gomez|
|Ciudad de México, DF, Mexico, 06720|
|Study Director:||Juan C García Beristain, MD||Hospital Infantil de Mexico Federico Gomez|
|Responsible Party:||Eduardo Javier Barragán Pérez, Chief of Neurology Department, Hospital Infantil de Mexico Federico Gomez|
|Other Study ID Numbers:||
|First Posted:||July 5, 2018 Key Record Dates|
|Last Update Posted:||September 24, 2019|
|Last Verified:||September 2019|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Rotational Field Quantum Magnetic Resonance (RFQMR)
High Grade Gliomas
Quantum Magnetic Resonance Therapy (QMRT)
Brain Tumor Recurrence
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Central Nervous System Diseases
Nervous System Diseases