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Recruiting NCT04763109

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

No phase Interventional Neurofibromatosis Type 1

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Whole-body Magnetic Resonance Imaging.
Who it may be relevant to
Registry conditions: Neurofibromatosis Type 1. Basic parameters: 5 years — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

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

Primary outcome measures

  • 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. [Time frame: From Baseline to within 4 weeks of baseline]
Secondary outcome measures (1)
  • 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

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

United States · 1 center
  • Cedars Sinai Medical Center — Los Angeles

Identifiers

NCT: NCT04763109 · IIT2020-23-BACA-MRINF1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗