Actively Recruiting

Phase Not Applicable
Age: 5Years - 17Years
All Genders
ID04763109

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

Age: 5Years - 17Years
All Genders

Eligibility Criteria

Eligible

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.
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Imaging Assessments

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

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Research Team

C

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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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