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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-17
SponsorNicole Baca

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Whole-body Magnetic Resonance Imaging

Treatment groups

15 Participants
are divided into 1 treatment group

Sponsors and collaborators

Nicole Baca

Lead sponsor

Cedars-Sinai Medical Center

Sponsor institution