Study for the Evaluation of the Feasibility of Applying Advanced MRI Scanning in Pediatric Clinical Practice

  • STATUS
    Recruiting
  • End date
    Jan 13, 2025
  • participants needed
    200
  • sponsor
    Neurological Associates of West Los Angeles
Updated on 23 February 2022
5 minute

Summary

The purpose of this research study is to evaluate the feasibility in conducting advanced MRI sequences in a pediatric clinical setting. The study will be observational in nature, and will only evaluate the studies of pediatric patients who have already been prescribed an advanced MRI for clinical neurological purposes. The only difference for the subject in participating in this study is that the data and information about their scan can be used and disclosed for research purposes, i.e. understanding if the time of the scan, patient comfort, and quality of the data are feasible. Standard MRI's have been extremely beneficial in the diagnosis and assessment of disease, injury, and anomalies throughout the body. Adding advanced MRI sequences to the arsenal of current standard MRI sequences, as well as analyzing the clinical significance of the data, may improve the benefits of MRI in the future. Within this scope, the study will be looking at the following factors:

  1. The total time of the scan, including:
    • Patient arrival time/lateness
    • Patient preparation time
    • Time scanner is being occupied
    • Patient compliance (is the patient continually stopping the study for breaks, fear, movement, etc.)
  2. Patient dropout rate, including:
    • Change of mind
    • Cost of study is too much
    • Failure to finish the scan
  3. Usability of data, including:
    • Movement artifact
    • Patient requiring re-scan for any reason

The scan will consist of two to five advanced MRI sequences that will average between 7-15 minutes each, in addition to a routine 5 minute standard MRI sequence. The variability in the number of advanced sequences depends on the prescription and patient history. All sequences are performed using a 1.5 Tesla Siemens MRI scanner at Westwood Open MRI, a 3 Tesla GE scanner at Tower Saint John's Imaging, or a 3 Tesla Siemens MRI scanner at Resolution Imaging. All scanners are FDA-approved.

Description

An MPRAGE is a high quality anatomical image of the brain. This is used as an anatomical overlay, so that all data collected from the advanced sequences below can be correlated with the correct brain areas in three-dimensional space.

  1. Resting BOLD - BOLD stands for blood oxygen level dependent. This functional sequence allows for the viewing of the thinking brain at rest, and looks at brain areas that are functionally working together at the same time. The brain is in one of its most active states when it is at rest, and literature has shown that a few neurological illnesses such as OCD, depression, and pain have been associated with analyzing the data in this sequence.
  2. Arterial Spin Labeling (ASL) - ASL tracks the blood flow in the brain visually and gives a statistical value of how much blood is in each region in cc's per 100 grams of brain per second.
  3. Diffusion Tensor Imaging (DTI) - DTI tractography shows the different fiber tracts in the brain using a 3D model. Fiber tracts are the physical neural pathways that can show disruption or connection in communication between different areas of the brain. This is an effective technique when looking at traumatic brain injury.
  4. Magnetic Resonance Spectroscopy (MRS) - MRS measures the ratios of select chemical compounds in the brain in relation to each other. This has shown to be effective in analyzing memory loss, dementia, and Alzheimer's type disorders.
  5. Stimulated BOLD - The same sequence as the resting BOLD, except the brain is being scanned during the completion of a task, instead of rest. By specifying the task (visual, problem solving, language, etc.), the different areas of the brain working together to complete this task can be imaged. This is very effective for task-specific symptoms and deficits.

The methods and procedures in this study are all under the observational category. MRI's are FDA approved and are non-experimental devices. The goal of this research is to assess the feasibility of the scan itself, so everything done with respect to the scan is considered observational in nature. If the subject drops out of the study, anything described in this protocol will still be able available to the subject as standard medical care. The observational procedures will involve recording data for the advanced MRI scans, and no information will be shared for research if the subject does not sign the consent form.

Details
Condition Neurodevelopmental Disorders
Clinical Study IdentifierNCT03232489
SponsorNeurological Associates of West Los Angeles
Last Modified on23 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

In order for a subject to be considered for this study, the following criteria
are
required
The subject is between the ages of neonate-18 years old
The subject clinically needs an advanced MRI
The assent of the subject and the agreement of parent(s) or guardian(s) to the participation of their child or ward in research, in accordance with the regulations set forth in the Belmont Report

Exclusion Criteria

In order for a subject to be considered for this study, he/she may NOT have
any of the following items in which cannot be removed prior to the MRI exam. A
subject that can remove any of the following prior to the MRI exam will still
be considered for the study
Aneurism clips
Cardiac pacemaker
Implanted cardioinverter defibrillator
Electronic implant or device
Magnetically activated implant or device
Neurostimulation system
Spinal cord stimulator
Internal electrodes or wires
Bone growth/bone fusion stimulator
Cochlear, otologic, or other ear implant
Insulin or other infusion pump
Implanted drug infusion device
Any type of prosthesis (eye, penile, etc.)
Heart valve prosthesis
Eyelid spring or wire
Artificial or prosthetic limb
No Metallic stent, filter, or coil
Shunt (spinal or intraventricular)
Vascular access port and/or catheter
Radiation seeds or implants
Swan-Ganz or thermodilution catheter
Medication patch (Nicotine, Nitroglycerine)
Any metallic fragment or foreign body
Wire mesh implant
Tissue expander (e.g., breast)
Surgical staples, clips, or metallic sutures
Joint replacement (hip, knee, etc.)
Bone/joint pin, screw, nail, wire, plate, etc
IUD, diaphragm, or pessary
Dentures or partial plates
Tattoo or permanent makeup
Body piercing jewelry
Hearing aid
As well as
Breathing problem or motion disorder
Severe claustrophobia
Any subjects from the following categories/groups will NOT be included in the
study
Prisoners
Poor/uninsured
Institutionalized
Limited or non-readers
Non-English speaking subjects
Wards of the state
Pregnant women
Nursing home residents recruited in the nursing home
Students of PI or study staff
Students recruited in the educational setting (school, class, etc.)
Employees directly supervised by the PI or sub-investigator
Employees of research site or sponsor
Military personnel recruited by military personnel
Cognitively impaired
Adult subjects that cannot consent for themselves
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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