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

Nicole Baca

Status: Enrolling

Conditions: Neurofibromatosis Type 1

Treatments: Other: Whole-body Magnetic Resonance Imaging

Study type: Interventional

Funder types: Other

Identifiers

NCT04763109

IIT2020-23-BACA-MRINF1

Details and patient eligibility

About

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.

Enrollment: 15 estimated patients

Sex: All

Ages: 5 to 17 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Whole-Body Magnetic Resonance Imaging

Experimental group

Treatment:

Other: Whole-body Magnetic Resonance Imaging