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NCT04763109 | RECRUITING | Neurofibromatosis Type 1

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

Nicole Baca

Information provided by (Responsible Party):

Nicole Baca

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.

Condition or disease

Neurofibromatosis Type 1

Intervention/treatment

Whole-body Magnetic Resonance Imaging

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 15 participants
Masking : NONE
Primary Purpose : OTHER
Official Title : Identification of Pre-Malignant Lesions In Pediatric Patients With Neurofibromatosis Type 1 Using Novel Magnetic Resonance Imaging Techniques Paired With Artificial Intelligence
Actual Study Start Date : 2022-07-08
Estimated Primary Completion Date : 2026-05
Estimated Study Completion Date : 2027-05

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 5 Years to 17 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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.
Identification of Pre-Malignant Lesions In Pediatric Patients With Neurofibromatosis Type 1 Using Novel Magnetic Resonance Imaging Techniques Paired With Artificial Intelligence

Location Details

NCT04763109

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Locations

RECRUITING

United States, California

Cedars Sinai Medical Center

Los Angeles, California, United States, 90048