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

Primary Purpose

Neurofibromatosis Type 1

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Whole-body Magnetic Resonance Imaging
Sponsored by
Nicole Baca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Neurofibromatosis Type 1 focused on measuring Pediatric, Neurofibromatosis Type 1, magnetic resonance imaging

Eligibility Criteria

5 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Cedars Sinai Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Whole-Body Magnetic Resonance Imaging

Arm Description

Outcomes

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.
T2 is a type of high-resolution multiparametric tissue mapping that measures quantitative metrics of the physical properties of tissue and allows comparison in longitudinal follow-up

Secondary Outcome Measures

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.
T1 and ACD is a type of high-resolution multiparametric tissue mapping that measures quantitative metrics of the physical properties of tissue and allows comparison in longitudinal follow-up

Full Information

First Posted
February 17, 2021
Last Updated
October 4, 2023
Sponsor
Nicole Baca
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1. Study Identification

Unique Protocol Identification Number
NCT04763109
Brief Title
Identification of Pre-Malignant Lesions In Pediatric Patients With Neurofibromatosis Type 1 Using Novel Magnetic Resonance Imaging Techniques Paired With Artificial Intelligence
Official Title
Identification of Pre-Malignant Lesions In Pediatric Patients With Neurofibromatosis Type 1 Using Novel Magnetic Resonance Imaging Techniques Paired With Artificial Intelligence
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 8, 2022 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
May 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Nicole Baca

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurofibromatosis Type 1
Keywords
Pediatric, Neurofibromatosis Type 1, magnetic resonance imaging

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Whole-Body Magnetic Resonance Imaging
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Whole-body Magnetic Resonance Imaging
Intervention Description
Whole-body Magnetic Resonance Imaging at baseline, 1 month, and 12 months
Primary Outcome Measure Information:
Title
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.
Description
T2 is a type of high-resolution multiparametric tissue mapping that measures quantitative metrics of the physical properties of tissue and allows comparison in longitudinal follow-up
Time Frame
From Baseline to within 4 weeks of baseline
Secondary Outcome Measure Information:
Title
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.
Description
T1 and ACD is a type of high-resolution multiparametric tissue mapping that measures quantitative metrics of the physical properties of tissue and allows comparison in longitudinal follow-up
Time Frame
From Baseline to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Karla Russell
Phone
310-967-2781
Email
Karla.Russell@cshs.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicole Baca, MD
Organizational Affiliation
Cedars-Sinai Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cedars Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karla Russell
Phone
310-967-2781
Email
Karla.Russell@cshs.org
First Name & Middle Initial & Last Name & Degree
Fataneh Majlessipour, MD
First Name & Middle Initial & Last Name & Degree
Pedro Sanchez, MD, MSCE
First Name & Middle Initial & Last Name & Degree
Edwin Posadas, MD
First Name & Middle Initial & Last Name & Degree
Debiao Li, PhD
First Name & Middle Initial & Last Name & Degree
Yibin Xie, PhD
First Name & Middle Initial & Last Name & Degree
Touseef Qureshi, PhD

12. IPD Sharing Statement

Learn more about this trial

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

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