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.
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.
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.
Single group
Whole-body Magnetic Resonance Imaging
Other interventionWhole-body Magnetic Resonance Imaging at baseline, 1 month, and 12 months
For scan re-scan reliability, utilize T2 imaging to evaluate the agreement between the baseline scan and the 1 Month scan, which is performed within 4 weeks of the baseline scan.
T2 is a type of high-resolution multiparametric tissue mapping that measures quantitative metrics of the physical properties of tissue and allows comparison in longitudinal follow-up
For change over time, the initial scan imaging using T1 and apparent diffusion coefficient (ACD) imaging, the baseline scan will be compared to the third scan, which is performed 12 months (+/- 3 months) after the baseline scan.
T1 and ACD is a type of high-resolution multiparametric tissue mapping that measures quantitative metrics of the physical properties of tissue and allows comparison in longitudinal follow-up
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Nicole Baca
Lead sponsor
Cedars-Sinai Medical Center
Sponsor institution
