RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2016-07
Study Completion:2025-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03232489

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.

Ages Eligible for Study:Not specified
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * The subject is between the ages of neonate-18 years old
  2. * The subject clinically needs an advanced MRI
  3. * 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
  1. * Aneurism clips
  2. * Cardiac pacemaker
  3. * Implanted cardioinverter defibrillator
  4. * Electronic implant or device
  5. * Magnetically activated implant or device
  6. * Neurostimulation system
  7. * Spinal cord stimulator
  8. * Internal electrodes or wires
  9. * Bone growth/bone fusion stimulator
  10. * Cochlear, otologic, or other ear implant
  11. * Insulin or other infusion pump
  12. * Implanted drug infusion device
  13. * Any type of prosthesis (eye, penile, etc.)
  14. * Heart valve prosthesis
  15. * Eyelid spring or wire
  16. * Artificial or prosthetic limb
  17. * No Metallic stent, filter, or coil
  18. * Shunt (spinal or intraventricular)
  19. * Vascular access port and/or catheter
  20. * Radiation seeds or implants
  21. * Swan-Ganz or thermodilution catheter
  22. * Medication patch (Nicotine, Nitroglycerine)
  23. * Any metallic fragment or foreign body
  24. * Wire mesh implant
  25. * Tissue expander (e.g., breast)
  26. * Surgical staples, clips, or metallic sutures
  27. * Joint replacement (hip, knee, etc.)
  28. * Bone/joint pin, screw, nail, wire, plate, etc.
  29. * IUD, diaphragm, or pessary
  30. * Dentures or partial plates
  31. * Tattoo or permanent makeup
  32. * Body piercing jewelry
  33. * Hearing aid
  34. * Breathing problem or motion disorder
  35. * Severe claustrophobia
  36. * Prisoners
  37. * Poor/uninsured
  38. * Institutionalized
  39. * Limited or non-readers
  40. * Non-English speaking subjects
  41. * Wards of the state
  42. * Pregnant women
  43. * Nursing home residents recruited in the nursing home
  44. * Students of PI or study staff
  45. * Students recruited in the educational setting (school, class, etc.)
  46. * Employees directly supervised by the PI or sub-investigator
  47. * Employees of research site or sponsor
  48. * Military personnel recruited by military personnel
  49. * Cognitively impaired
  50. * Adult subjects that cannot consent for themselves

Contacts and Locations

Study Contact

Sheldon Jordan, MD, FAAN
CONTACT
3108295968
shellyj@aol.com
Robin Blades, BA
CONTACT
3108295968
rblades@theneuroassociates.com

Principal Investigator

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

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Neurological Associates of West Los Angeles

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2016-07
Study Completion Date2025-01

Study Record Updates

Study Start Date2016-07
Study Completion Date2025-01

Terms related to this study

Additional Relevant MeSH Terms

  • Neurodevelopmental Disorders