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Dynamic Airway CT Scan for Tracheomalacia in Children

N/A
Recruiting
Led By Eleanor Muise, MD
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants 0-18 years old, with clinically indicated flexible bronchoscopy has been performed
Be younger than 65 years old
Must not have
Unable to undergo CT scanning without sedation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights
No Placebo-Only Group

Summary

This trial studies whether Dynamic Airway CT can accurately diagnose tracheomalacia in children 0-18 without the need for a bronchoscopy. Results will help plan a more precise study.

Who is the study for?
This trial is for children aged 0-18 who may have tracheomalacia, a condition where the windpipe collapses when breathing. They must have already undergone a flexible bronchoscopy. It's not for pregnant or breastfeeding individuals, those who can't have a CT scan without sedation, or patients with a tracheostomy.
What is being tested?
The study is testing Dynamic Airway CT scans (DA-CT) as a noninvasive way to diagnose tracheomalacia in kids. The goal is to see if DA-CT can be as good as bronchoscopy by looking at its accuracy and image quality while also checking how much radiation it exposes the kids to.
What are the potential side effects?
Since this trial involves imaging rather than medication, side effects are minimal but may include discomfort from staying still during the scan and exposure to low levels of radiation typical of medical CT scans.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 or younger and have had a flexible bronchoscopy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I need sedation to have a CT scan.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Severity of Excessive dynamic airway collapse (EDAC) on DA-CT
Severity of Maximal Airway Change (MAC) on DA-CT
Severity of dynamic narrowing on Flexible Bronchoscopy
Secondary study objectives
Contrast-to-noise-ratio (CNR) of DA-CT scanners
Qualitative Analysis of DA-CT Image Quality based on 5-point Likert scale
Qualitative Analysis of DA-CT delineation of large airways based on 5-point Likert scale
+4 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Dynamic Airway CT scan (DA-CT)Experimental Treatment1 Intervention
All participants will have a DA-CT scan after flexible bronchoscopy has been performed.

Find a Location

Who is running the clinical trial?

NYU Langone HealthLead Sponsor
1,410 Previous Clinical Trials
855,581 Total Patients Enrolled
Eleanor Muise, MDPrincipal InvestigatorNYU Langone Health
~8 spots leftby Jun 2025
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