RecruitingNot ApplicableNCT04763109

Identification of Pre-Malignant Lesions In Pediatric Patients With Neurofibromatosis Type 1 Using Novel Magnetic Resonance Imaging Techniques Paired With Artificial Intelligence


Sponsor

Nicole Baca

Enrollment

15 participants

Start Date

Jul 8, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

This is a single arm pilot trial of a novel whole-body Magnetic Resonance Imaging paired with artificial intelligence intervention, to evaluate feasibility defined as scan-rescan reliability, and to estimate the positive predictive value of changes in Magnetic Resonance Imaging scans from baseline to 12-month visit using an Artificial Intelligence algorithm, among 15 pediatric patients with neurofibromatosis type 1 at Cedars-Sinai Medical Center.


Eligibility

Min Age: 5 YearsMax Age: 17 Years

Inclusion Criteria2

  • Between the ages of 5 and <18 years at the start of study. If subject will turn 18 during the study, they will be allowed to enroll.
  • Clinically or molecularly confirmed diagnosis of NF-1. Subjects with mosaic/segmental NF-1 also qualify for the study.

Exclusion Criteria4

  • Requiring sedation for imaging.
  • Implants and/or Devices: Mechanical, magnetic or electrical activated implants; Ferromagnetic implants and foreign bodies
  • Claustrophobia, problems being in enclosed spaces, or inability to lie facing upwards.
  • Allergy to animal dander or animal-instigated asthma.

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Interventions

OTHERWhole-body Magnetic Resonance Imaging

Whole-body Magnetic Resonance Imaging at baseline, 1 month, and 12 months


Locations(1)

Cedars Sinai Medical Center

Los Angeles, California, United States

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NCT04763109


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