Identification of Pre-Malignant Lesions In Pediatric Patients With Neurofibromatosis Type 1 Using Novel Magnetic Resonance Imaging Techniques Paired With Artificial Intelligence
Not Applicable
Recruiting
- Conditions
- Neurofibromatosis Type 1
- Registration Number
- NCT04763109
- Lead Sponsor
- Nicole Baca
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Inclusion Criteria:<br><br> - Between the ages of 5 and <18 years at the start of study. If subject will turn 18<br> during the study, they will be allowed to enroll.<br><br> - Clinically or molecularly confirmed diagnosis of NF-1. Subjects with<br> mosaic/segmental NF-1 also qualify for the study.<br><br>Exclusion Criteria:<br><br> - Requiring sedation for imaging.<br><br> - Implants and/or Devices: Mechanical, magnetic or electrical activated implants;<br> Ferromagnetic implants and foreign bodies<br><br> - Claustrophobia, problems being in enclosed spaces, or inability to lie facing<br> upwards.<br><br> - Allergy to animal dander or animal-instigated asthma.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method 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.