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

NCT ID: NCT04763109

Last Updated: 2025-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-08

Study Completion Date

2027-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Neurofibromatosis Type 1

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Whole-Body Magnetic Resonance Imaging

Group Type EXPERIMENTAL

Whole-body Magnetic Resonance Imaging

Intervention Type OTHER

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

Interventions

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Whole-body Magnetic Resonance Imaging

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

5 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nicole Baca

OTHER

Sponsor Role lead

Responsible Party

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Nicole Baca

Assistant Professor of Department of Pediatrics

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Nicole Baca, MD

Role: PRINCIPAL_INVESTIGATOR

Cedars-Sinai Medical Center

Locations

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Cedars Sinai Medical Center

Los Angeles, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Clinical Trial Recruitment Navigator

Role: CONTACT

3104232133

Facility Contacts

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Clinical Trial Recruitment Navigator

Role: primary

3104232133

Other Identifiers

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IIT2020-23-BACA-MRINF1

Identifier Type: -

Identifier Source: org_study_id

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