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

Description

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.

Conditions

Neurodevelopmental Disorders

Study Overview

Study Details

Study overview

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.

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

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

Condition
Neurodevelopmental Disorders
Intervention / Treatment

-

Contacts and Locations

Santa Monica

Neurological Associates of West Los Angeles, Santa Monica, California, United States, 90403

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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
  • * 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
  • * Breathing problem or motion disorder
  • * Severe claustrophobia
  • * 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

Ages Eligible for Study

to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Neurological Associates of West Los Angeles,

Sheldon Jordan, MD, FAAN, PRINCIPAL_INVESTIGATOR, Neurological Associates of West Los Angeles

Study Record Dates

2025-01