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

Study Overview
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Brief Summary
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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.

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

Conditions
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Neurofibromatosis Type 1

Intervention / Treatment
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* Other: Whole-body Magnetic Resonance Imaging


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Whole-Body Magnetic Resonance Imaging<br> | Other: Whole-body Magnetic Resonance Imaging<br>* Whole-body Magnetic Resonance Imaging at baseline, 1 month, and 12 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | From Baseline to within 4 weeks of baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | From Baseline to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pediatric, Neurofibromatosis Type 1, magnetic resonance imaging