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

Neurofibromatosis Type 1 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04763109
• Other study ID #: IIT2020-23-BACA-MRINF1
• Status: Recruiting
• Phase: N/A
• Start date: July 8, 2022
• Est. completion date: May 2025

Study information

• Verified date: October 2023
• Source: Cedars-Sinai Medical Center
• Contact: Clinical Trial Recruitment Navigator
• Phone: 3104232133
• Email: cancer.trial.info[@]cshs.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: May 2025
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Neurofibroma
• Neurofibromatoses
• Neurofibromatosis 1
• Neurofibromatosis Type 1
• Precancerous Conditions

Intervention

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

Locations

Country	Name	City	State
United States	Cedars Sinai Medical Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Nicole Baca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	From Baseline to within 4 weeks of baseline
Secondary	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	From Baseline to 12 months