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AI-Enhanced MRI for Detecting Precancerous Lesions in Neurofibromatosis
N/A
Recruiting
Led By Nicole Baca, MD
Research Sponsored by Nicole Baca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to 12 months
Awards & highlights
Study Summary
This trial is testing a new MRI scan that uses AI to see if it can predict neurofibromatosis type 1 in children.
Who is the study for?
This trial is for pediatric patients aged 5 to less than 18 with confirmed Neurofibromatosis Type 1. It's open even if they turn 18 during the study. However, it excludes those needing sedation for imaging, with allergies to animal dander or asthma triggered by animals, ferromagnetic implants or foreign bodies, and claustrophobia.Check my eligibility
What is being tested?
The trial tests a new whole-body MRI technique paired with AI in detecting pre-malignant lesions in kids with Neurofibromatosis Type 1. The goal is to check how reliable the scans are over time and predict changes from initial scan to follow-up at one year.See study design
What are the potential side effects?
Since this trial involves MRI scans which are non-invasive, there are typically no direct side effects associated with the procedure itself. However, discomfort due to lying still or being in an enclosed space may occur.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from baseline to 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Radionuclide Imaging
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.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Whole-Body Magnetic Resonance ImagingExperimental Treatment1 Intervention
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Who is running the clinical trial?
Nicole BacaLead Sponsor
Nicole Baca, MDPrincipal InvestigatorCedars-Sinai Medical Center
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am claustrophobic or cannot lie on my back.You are allergic to animal fur or have asthma triggered by animals.You have certain implants or devices that could be affected by magnets or electricity.I need medicine to help me stay calm for scans.I have been diagnosed with NF-1, including a less common form known as mosaic NF-1.I am between 5 and 17 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Whole-Body Magnetic Resonance Imaging
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Do I satisfy the criteria to participate in this experiment?
"This clinical trial requires 15 minors between 5 and 17 years old who are diagnosed with neurofibromatoses. Eligible participants must also be younger than 18 at the commencement of the study, even if they turn 18 during its duration."
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