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

NCT ID: NCT04763109Sponsor: Nicole BacaLast updated: 2026-05-07

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.

Arms & interventions

  • OtherWhole-body Magnetic Resonance Imaging

    Whole-body Magnetic Resonance Imaging at baseline, 1 month, and 12 months

Outcome measures

Primary

  • 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.

    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

    Time frame: From Baseline to within 4 weeks of baseline

Secondary

  • 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.

    Time frame: From Baseline to 12 months

Eligibility criteria

Sex: AllAge: 5 Years to 17 YearsHealthy 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.

Study locations (1)

Cedars Sinai Medical Center

Los Angeles, California, 90048

Recruiting
Clinical Trial Recruitment Navigator · Contact
Fataneh Majlessipour, MD · Sub Investigator
Pedro Sanchez, MD, MSCE · Sub Investigator
Edwin Posadas, MD · Sub Investigator
Debiao Li, PhD · Sub Investigator
Yibin Xie, PhD · Sub Investigator
Touseef Qureshi, PhD · Sub Investigator