Recruiting

Magnetic Resonance Imaging

Sponsor:

Nicole Baca

Code:

NCT04763109

Conditions

Neurofibromatosis Type 1

Eligibility Criteria

Sex: All

Age: 5 - 17

Healthy Volunteers: Not accepted

Interventions

Whole-body Magnetic Resonance Imaging

Study Details

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.

Conditions

Neurofibromatosis Type 1

Study ID

NCT04763109

Start date

Jul 8, 2022

Status verified date

May, 2026

Completion date

May, 2029

Anticipated

Primary completion date

May, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 5 - 17

Healthy Volunteers: Not accepted

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 Design

Enrollment

15 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Whole-Body Magnetic Resonance Imaging

Interventions

Whole-body Magnetic Resonance Imaging

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

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Clinical Trial Recruitment Navigator

3104232133GroupCancerTrialInformation@cshs.org

Locations

Cedars Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Contacts

Clinical Trial Recruitment Navigator

310-423-2133GroupCancerTrialInformation@cshs.org

More Information

Sponsor

Nicole Baca

Last update posted

May 7, 2026

Last verified

May, 2026

Keywords

  • Pediatric
  • Neurofibromatosis Type 1
  • magnetic resonance imaging

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Nicole Baca on 2026-05-07.