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

NCT03232489 | Unknown

• 1 other identifier: 20161363
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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:

• 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.)
• Patient dropout rate, including:
• Change of mind
• Cost of study is too much
• Failure to finish the scan
• 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

Outcome Measures

Primary Outcomes (1)

• Number of subjects who successfully complete an fMRI scan

  In order to assess scan feasibility, we will keep track of the total number of patients who sign the consent form and are able to complete the fMRI scan.

  Through study completion, an average of 1 year

Secondary Outcomes (10)

• Subject appointment time vs. subject arrival time

  Through study completion, an average of 1 year

• Time it takes subject to get from checked-in to start of scan (in minutes)

  Through study completion, an average of 1 year

• How long was the scanner unoccupied (in minutes)

  Through study completion, an average of 1 year

• Number and type of sequences performed

  Through study completion, an average of 1 year

• Time of scan (in minutes)

  Through study completion, an average of 1 year

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The subjects in this research study will be recruited by routine medical office exam.The ages for the subjects in this study will range from neonates to 18 years old.The gender distribution for this study will aim for a ratio of 50:50 male to female. There are no enrollment restrictions based upon race or ethnic origin. There are also no additional benefits, risks, advantages, or disadvantages based off of any race or ethnic origin.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Neurological Associates of West Los Angeles: lead

Study Sites (1)

Neurological Associates of West Los Angeles

Santa Monica, California, 90403, United States

RECRUITING

MeSH Terms

Conditions

Neurodevelopmental Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Sheldon Jordan, MD, FAAN

  Neurological Associates of West Los Angeles

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sheldon Jordan, MD, FAAN

CONTACT

3108295968; shellyj@aol.com

Robin Blades, BA

CONTACT

3108295968; rblades@theneuroassociates.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neurologist

Study Record Dates

• First Submitted: June 12, 2017
• First Posted: July 28, 2017
• Study Start: July 1, 2016
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: September 28, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)