Dynamic Airway CT Scan for Tracheomalacia in Children

Recruiting at 1 trial location

Overseen By Soumia Hammouda

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Disqualifiers: Pregnancy, Breastfeeding, Tracheostomy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

25 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to diagnose tracheomalacia, a condition where the windpipe (trachea) is too floppy and can cause breathing problems in children. Researchers aim to determine if a Dynamic Airway CT scan (a special type of imaging) can match the effectiveness of the usual procedure, flexible bronchoscopy, with less invasiveness. Children who have already undergone a flexible bronchoscopy might be suitable for this study. The results will help determine if this new method could be used more widely in the future. As an unphased trial, this study offers a unique opportunity to contribute to innovative diagnostic methods that could benefit many children.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that Dynamic Airway CT scan is safe for diagnosing tracheomalacia in children?

Research has shown that the Dynamic Airway CT scan (DA-CT) is generally easy for patients to handle. Doctors use it to examine the trachea, or windpipe, in children with tracheomalacia, a condition where the airway is floppy. Studies have found that DA-CT provides clear images of the airway without causing major side effects, helping doctors pinpoint the location and severity of airway problems.

While specific data on side effects from DA-CT is lacking, CT scans in general use low levels of radiation and are considered safe. The radiation from a DA-CT scan is carefully managed to minimize any risk to patients, making it a promising noninvasive alternative to the more invasive flexible bronchoscopy.

Overall, research suggests that DA-CT is a safe method for assessing airway issues in children. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using the Dynamic Airway CT scan (DA-CT) for tracheomalacia in children because it offers a non-invasive way to visualize the airways in real-time, which could enhance diagnosis compared to traditional methods like flexible bronchoscopy. Unlike bronchoscopy, which requires sedation and is more invasive, the DA-CT scan provides dynamic imaging that can capture airway collapse as it happens, potentially leading to more accurate and timely diagnoses. This advancement could help in tailoring treatments more effectively for each child, improving their quality of life.

What evidence suggests that Dynamic Airway CT scan is effective for diagnosing tracheomalacia in children?

Research has shown that Dynamic Airway CT (DA-CT), which all participants in this trial will undergo, can effectively detect airway narrowing in conditions like tracheomalacia. Studies indicate that DA-CT provides real-time, detailed images that enhance understanding of this condition. Ultralow dose DA-CT accurately identifies tracheomalacia, rarely giving false alarms. It also has a high positive predictive value, meaning when DA-CT suggests tracheomalacia, it is very likely correct. This makes DA-CT a promising tool for diagnosing tracheomalacia in children, potentially offering a noninvasive alternative to flexible bronchoscopy. ^{1 3 6 7 8}

Who Is on the Research Team?

Eleanor Muise, MD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am 18 or younger and have had a flexible bronchoscopy.

Exclusion Criteria

I need sedation to have a CT scan.

Pregnancy or breastfeeding

You have a tracheostomy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Diagnostic Procedure

Participants undergo a Dynamic Airway CT scan (DA-CT) after flexible bronchoscopy

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the diagnostic procedure

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Dynamic Airway CT scan (DA-CT)

Trial Overview

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.

How Is the Trial Designed?

Group I: Dynamic Airway CT scan (DA-CT) Experimental Treatment 1 Intervention

All participants will have a DA-CT scan after flexible bronchoscopy has been performed.

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Published Research Related to This Trial

In a study of 28 children suspected of tracheomalacia (TM), flexible bronchoscopy confirmed TM in 26 cases, highlighting the effectiveness of this method for diagnosis.

Multi-detector CT (MDCT) was found to be a reliable alternative for diagnosing TM, with a recommended cut-off for the cross-sectional area ratio (CSR) of ≤0.7, achieving 84.6% sensitivity and 100% specificity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Helical multi-detector CT scan as a tool for diagnosing tracheomalacia in children. Douros, K., Kremmydas, G., Grammeniatis, V., et al.[2020]

Dynamic volumetric computed tomography angiography (DV-CTA) can effectively diagnose tracheomalacia in children without the need for sedation or respiratory manipulation, making it a safer alternative to traditional bronchoscopy.

In a study of 32 children, DV-CTA showed excellent agreement with bronchoscopy results for diagnosing tracheomalacia, with a correlation coefficient of κ = 0.81, which improved to κ = 0.91 when studies were conducted within 30 days of each other.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dynamic Volumetric Computed Tomography Angiography is an Effective Method to Evaluate Tracheomalacia in Children. Koenigs, M., Young, C., Lillis, A., et al.[2023]

In a study of 33 children using dynamic 4-D CT imaging of the airways, 61% were found to have tracheobronchomalacia, indicating that this imaging technique is effective for diagnosing airway collapse without the need for anesthesia.

The mean effective radiation dose for dynamic 4-D CT was comparable to routine chest CT scans, at 1.0 mSv, suggesting that this method is a safe imaging option for children, with most cases of tracheobronchomalacia managed successfully through conservative treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Technique, pitfalls, quality, radiation dose and findings of dynamic 4-dimensional computed tomography for airway imaging in infants and children. Andronikou, S., Chopra, M., Langton-Hewer, S., et al.[2020]

Dynamic computed tomography (dCT) effectively diagnosed tracheobronchomalacia (TBM) in 53% of the 70 premature infants studied, providing critical insights into airway narrowing and severity levels.

The findings from dCT led to significant management changes in patient care, including adjustments in ventilation strategies and medication, highlighting its role as a valuable noninvasive tool for guiding treatment in this vulnerable population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dynamic computed tomography for evaluation of tracheobronchomalacia in premature infants with bronchopulmonary dysplasia. Pugh, CP., Ali, S., Agarwal, A., et al.[2023]

Volumetric CT is a non-invasive and effective method for assessing the pediatric airway, particularly for conditions like tracheobronchomalacia, without the need for intubation or patient cooperation.

This technique provides a four-dimensional view of the airway at a significantly lower radiation dose compared to traditional dynamic CT imaging, making it safer for infants with complex respiratory issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dynamic volumetric computed tomographic assessment of the young paediatric airway: Initial experience of rapid, non-invasive, four-dimensional technique. Tan, JZ., Crossett, M., Ditchfield, M.[2022]

Advancements in multidetector computed tomography (MDCT) technology have significantly improved the noninvasive assessment of large airways in children, allowing for better diagnosis of airway diseases.

The 320-MDCT scanner offers detailed anatomical and functional information, making it particularly useful for evaluating dynamic airway conditions like tracheobronchomalacia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multidetector computed tomography of pediatric large airway diseases: state-of-the-art. Lee, EY., Greenberg, SB., Boiselle, PM.[2016]

Ultralow dose dynamic expiratory CT (ULD) for evaluating tracheomalacia resulted in a very low average effective radiation dose of 0.08 mSv, which is a 95% reduction compared to typical dose CT, making it a safer imaging option.

Despite a slight decrease in image quality compared to typical dose CT, ULD maintained diagnostic quality for all studies, with better image quality observed at 100 kVp compared to 80 kVp.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultralow Dose Dynamic Expiratory Computed Tomography for Evaluation of Tracheomalacia. Cohen, SL., Ben-Levi, E., Karp, JB., et al.[2019]

A novel 320-row multidetector computed tomography (MDCT) technique effectively diagnosed tracheomalacia in all 6 adult patients studied, revealing that the proximal trachea collapses later during expiration compared to the distal trachea.

The most common site of airway collapse was at the aortic arch, and the imaging technique provided a detailed assessment of airway dynamics while maintaining a relatively low radiation dose, making it a promising method for evaluating tracheomalacia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dynamic airway evaluation with volume CT: initial experience. Wagnetz, U., Roberts, HC., Chung, T., et al.[2019]

In a study of 30 pediatric patients (15 with tracheomalacia and 15 without), those with tracheomalacia exhibited significantly higher severity and frequency of air trapping, indicating a clear difference in lung function between the two groups.

All patients with tracheomalacia showed air trapping, with a median score of 5.0, compared to a median score of 3.0 in the comparison group, suggesting that tracheomalacia is associated with more severe respiratory issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Expiratory volumetric MDCT evaluation of air trapping in pediatric patients with and without tracheomalacia. Lee, EY., Tracy, DA., Bastos, Md., et al.[2016]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10993911/

Dynamic Computed Tomography for Evaluation of ...

Dynamic computed tomography (dCT) gives real-time physiological information and objective descriptions of airway narrowing in tracheobronchomalacia (TBM).

2.

onlinelibrary.wiley.com

onlinelibrary.wiley.com/doi/10.1002/ppul.26844

Dynamic airway computed tomography and flexible ...

Ultralow dose DACT has excellent specificity and positive predictive value for both detection of TM and categorizing severity of tracheal collapse.

3.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0165587625003830

4D-Computed Tomography in the Evaluation of Dynamic ...

In this study we aim to prove we can compare 4D CT findings in children with clinically suspected tracheomalacia to a normalized 3D ...

4.

withpower.com

withpower.com/trial/phase-tracheomalacia-7-2023-56cbd

Dynamic Airway CT Scan for Tracheomalacia in Children

Research shows that Dynamic CT can provide real-time information and detailed images of airway narrowing, which helps in understanding and managing conditions ...

5.

ajronline.org

ajronline.org/doi/10.2214/AJR.11.8014

Dynamic Pulmonary CT of Children | AJR

Wide-detector dynamic CT is ideal for evaluation of the airway and lungs in infants and small children with persistent respiratory distress.

6.

aao-hnsfjournals.onlinelibrary.wiley.com

aao-hnsfjournals.onlinelibrary.wiley.com/doi/10.1002/ohn.1313

Dynamic Airway CT for Morphometric Analysis of Pediatric ...

Dynamic airway computed topography (4D-CT) can be used to evaluate the trachea in pediatric patients with tracheomalacia. The 4D-CT enables ...

7.

trialx.com

trialx.com/clinical-trials/listings/275558/dynamic-airway-ct-is-diagnostic-for-tracheomalacia-in-children/

Dynamic Airway CT is Diagnostic for Tracheomalacia in ...

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 ...

8.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38197524/

Dynamic airway computed tomography and flexible ...

Dynamic airway computed tomography and flexible bronchoscopy for diagnosis of tracheomalacia in children: A comparison study. Pediatr ...