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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Nicole Baca
Study ID
NCT04763109
Status
Recruiting
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Conditions

  • Neurofibromatosis Type 1

Eligibility Criteria

Sex
ALL
Age
5 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jul 8, 2022
Status verified
May 2026
Primary completion
May 31, 2028
Completion
May 31, 2029

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: Whole-Body Magnetic Resonance Imaging

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

Locations (1)

FacilityCityStateZIPSite coordinators
Cedars Sinai Medical CenterLos AngelesCalifornia90048
Clinical Trial Recruitment Navigator
[email protected]
310-423-2133
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)

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By research site
Cedars Sinai Medical Center· Los Angeles, CA

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