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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

Must not have

Claustrophobia, problems being in enclosed spaces, or inability to lie facing upwards.

Requiring sedation for imaging.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline to 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial uses a full-body scan and smart computer software to monitor changes in pediatric patients with neurofibromatosis type 1. The MRI takes detailed images, and the AI analyzes them to track any changes over time.

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.

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.

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.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am claustrophobic or cannot lie on my back.

Select...

I need medicine to help me stay calm for scans.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Radionuclide Imaging

Secondary study objectives

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.