Neurofibromatosis Type 1
Conditions
Keywords
Pediatric, Neurofibromatosis Type 1, magnetic resonance imaging
Brief summary
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.
Interventions
Whole-body Magnetic Resonance Imaging at baseline, 1 month, and 12 months
Sponsors
Nicole Baca
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to 17 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | From Baseline to within 4 weeks of baseline | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | From Baseline to 12 months | 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 |
Countries
United States
Contacts
CONTACTClinical Trial Recruitment Navigator
PRINCIPAL_INVESTIGATORNicole Baca, MD
Cedars-Sinai Medical Center
Outcome results
None listed