Actively Recruiting
Identification of Pre-Malignant Lesions In Pediatric Patients With Neurofibromatosis Type 1 Using Novel Magnetic Resonance Imaging Techniques Paired With Artificial Intelligence
Led by Nicole Baca · Updated on 2026-05-07
15
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new approach using whole-body Magnetic Resonance Imaging (MRI) combined with artificial intelligence to study pre-malignant lesions in children aged 5 to 17 years with neurofibromatosis type 1. This pilot trial aims to assess how reliable the MRI scans are when repeated and to estimate how well changes detected by the AI in MRI images over 12 months predict the condition's progression. The study is conducted at Cedars-Sinai Medical Center and involves 15 pediatric patients. Participants will undergo whole-body MRI scans at three time points: the start of the study (baseline), one month later, and at approximately 12 months. The AI algorithm will analyze these scans to evaluate the agreement between the baseline and 1-month scans using T2 imaging, and to compare baseline scans to the 12-month scans using T1 and apparent diffusion coefficient imaging. This helps to understand the scan reliability and the predictive value of MRI changes over time. During the study, children will have MRI scans without sedation if possible, and their images will be carefully reviewed using advanced imaging techniques and AI analysis. Researchers will monitor scan consistency and changes over the year-long period. The primary measure is the agreement between baseline and 1-month scans, while secondary measures assess changes up to 12 months. Participation involves regular imaging visits and close monitoring until the study ends in May 2029.
CONDITIONS
Brief Title
Identification of Pre-Malignant Lesions In Pediatric Patients With Neurofibromatosis Type 1 Using Novel Magnetic Resonance Imaging Techniques Paired With Artificial Intelligence
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Between the ages of 5 and under 18 years at the start of the study. Participants turning 18 during the study are allowed to enroll.
- Clinically or molecularly confirmed diagnosis of neurofibromatosis type 1, including mosaic or segmental forms.
You will not qualify if you...
- Requiring sedation for imaging.
- Having mechanical, magnetic, or electrical implants or ferromagnetic foreign bodies.
- Claustrophobia, problems being in enclosed spaces, or inability to lie facing upwards.
- Allergy to animal dander or animal-instigated asthma.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 months (+/- 3 months)
Participants undergo whole-body magnetic resonance imaging to identify pre-malignant lesions using novel imaging techniques paired with artificial intelligence.
3 visits (in-person) at baseline, 1 month, and 12 months
Trial Site Locations
Total: 1 location
1
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
Research Team
C
Clinical Trial Recruitment Navigator
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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