Dynamic Airway CT is Diagnostic for Tracheomalacia in Children

• Sponsor: NYU Langone Health (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT06028646
• Collaborator: (none)
• Enrollment: 25
• Locations: 2
• Arm: 1
• Anticipated Duration (Months): 2
• Patients Per Site: 12.5
• Patients Per Site Per Month: 6.2

Study Details

Study Description

Brief Summary

The purpose of this pilot interventional study is to evaluate the use of Dynamic Airway Computed Tomography (DA-CT) for diagnosis of tracheomalacia in children 0-18 years for whom flexible bronchoscopy has been performed. The primary aims are to evaluate the diagnostic accuracy, image quality, and radiation exposure of DA-CT as a potential noninvasive alternative to the gold standard of flexible bronchoscopy in the diagnosis of tracheomalacia. The results from this pilot study will help to estimate sample size for a larger-scale study with more precise estimates of DA-CT diagnostic potential.

Condition or Disease	Intervention/Treatment	Phase
Tracheomalacia	Device: Dynamic Airway CT scan (DA-CT)	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 25 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Dynamic Airway CT is Diagnostic for Tracheomalacia in Children
• Actual Study Start Date: Aug 10, 2023
• Anticipated Primary Completion Date: Oct 10, 2023
• Anticipated Study Completion Date: Oct 10, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dynamic Airway CT scan (DA-CT) All participants will have a DA-CT scan after flexible bronchoscopy has been performed.	Device: Dynamic Airway CT scan (DA-CT); Patient will be asked to perform movements during the scan.

Outcome Measures

Primary Outcome Measures

1. Severity of dynamic narrowing on Flexible Bronchoscopy [Through study completion, an average of 1 year]

   Video recordings and images will be deidentified and reviewed by pediatric pulmonologists and scores averaged. Severity of dynamic narrowing will be classified as follows: mild: 50%-74%, moderate: 75%-89%, severe: >90%.

2. Severity of Maximal Airway Change (MAC) on DA-CT [Through study completion, an average of 1 year]

   Severity of MAC will be classified as follows: mild: 33%-49%, moderate: 50%-66%, severe: >67%. This outcome will be measured using the following equation: MAC = tracheal cross-sectional (CSA) at narrowed segment in inspiration/CSA of trachea at thoracic inlet in inspiration

3. Severity of Excessive dynamic airway collapse (EDAC) on DA-CT [Through study completion, an average of 1 year]

   Severity of EDAC will be classified as follows: mild: 50%-74%, moderate: 75%-89%, severe: >90%. This outcome will be measured using the following equation: EDAC = CSA at airway segment in expiration/CSA at same location in inspiration

Secondary Outcome Measures

1. Contrast-to-noise-ratio (CNR) of DA-CT scanners [Through study completion, an average of 1 year]

   This outcome will be measured using the following equation: CNR = (mean Hounsfield Units (HU) in the artery regions of interest (ROI) - mean HU in the tracheal air column ROI) / image noise inside the trachea.

2. Qualitative Analysis of DA-CT Image Quality based on 5-point Likert scale [Through study completion, an average of 1 year]

   5-point Likert scale will be used as follows: (1) Very Poor, (2) Poor, (3) Fair, (4) Good, (5) Excellent

3. Qualitative Analysis of DA-CT image noise based on 5-point Likert scale [Through study completion, an average of 1 year]

   5-point Likert scale will be used as follows: (1) Very Poor, (2) Poor, (3) Fair, (4) Good, (5) Excellent

4. Qualitative Analysis of DA-CT delineation of large airways based on 5-point Likert scale [Through study completion, an average of 1 year]

   5-point Likert scale will be used as follows: (1) Very Poor, (2) Poor, (3) Fair, (4) Good, (5) Excellent

5. Qualitative Analysis of DA-CT delineation of small airways based on 5-point Likert scale [Through study completion, an average of 1 year]

   5-point Likert scale will be used as follows: (1) Very Poor, (2) Poor, (3) Fair, (4) Good, (5) Excellent

6. Qualitative Analysis of DA-CT noise texture based on 5-point Likert scale [Through study completion, an average of 1 year]

   5-point Likert scale will be used as follows: (1) Very Poor, (2) Poor, (3) Fair, (4) Good, (5) Excellent

7. Radiation exposure of DA-CT scanners [Through study completion, an average of 1 year]

   The effective dose (in mSv) will be automatically calculated with tissue weighting factors

Eligibility Criteria

Criteria

• Ages Eligible for Study: 0 Years to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Participants 0-18 years old, with

• Clinically indicated flexible bronchoscopy has been performed

Exclusion Criteria:

• Pregnancy or breastfeeding

• Unable to undergo CT scanning without sedation

• Patients with tracheostomy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fink Children's Ambulatory Center/Hassenfeld Children's Center	New York	New York	United States	10016
2	Tisch Hospital	New York	New York	United States	10016

Sponsors and Collaborators

• NYU Langone Health

Investigators

• Principal Investigator: Eleanor Muise, MD, NYU Langone Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: NYU Langone Health
• ClinicalTrials.gov Identifier: NCT06028646
• Other Study ID Numbers: 22-01279
• First Posted: Sep 8, 2023
• Last Update Posted: Sep 8, 2023
• Last Verified: Sep 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Keywords provided by NYU Langone Health: Tracheomalacia in Children
• Additional relevant MeSH terms: Tracheomalacia

Study Results

No Results Posted as of Sep 8, 2023