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WithdrawnNCT04977830Updated Mar 5, 2026

Pulmonary Assessment in Thoracic Insufficiency Syndrome Patients

An interventional study of Xenon-129 in Thoracic Insufficiency Syndrome, sponsored by Patrick Cahill, MD. Withdrawn at 1 site in United States. Open to participants aged 6 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-03-05.

Sponsored by Patrick Cahill, MD · Not applicable, Interventional, and Basic science

Why this study was withdrawn
Discontinued relationship with vendor. Currently investigating alternatives.
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
6 Years to 18 Years
Sex
All
01

Study summary

Thoracic insufficiency syndrome (TIS) is a complex condition that involves chest wall deformities that can affect normal breathing and lung growth. In most cases, children with TIS are also born with spine disorders such as scoliosis. The inability of the thorax to support normal respiration or lung growth can cause respiratory distress and even mortality. Investigators aim to validate MRI imaging sequences to use as an assessment tool for pulmonary function.

02

Conditions studied

  • Thoracic Insufficiency Syndrome

Keywords

  • Hyperpolarized MRI
  • Dynamic Lung MRI
03

In context

Lead sponsor

Patrick Cahill, MD is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Males or females 6 to 18 years old diagnosed with thoracic insufficiency syndrome who are undergoing surgery

Exclusion criteria

Exclusion Criteria:

  • patients not diagnosed with thoracic insufficiency syndrome
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Other
    Thoracic Insufficiency Group

    Thoracic insufficiency syndrome patients undergoing surgery

    Device: Xenon-129

Interventions

  • DeviceXenon-129

    Patients will undergo a hyperpolarized MRI with administered Xenon gas

06

What researchers measure

Primary outcomes

  1. Analyze volume of lungs at end-inspiration and end-expiration

    Investigators will analyze lung volume at end-inspiration and end-expiration will be assessed by performing a thoracic dynamic magnetic resonance imaging scan; measured in total volume units (mL)

    Time frame: up to 2 years

  2. Xenon-129 MRI Ventilation Maps

    Xenon-129 MRI will be completed to reveal unventilated regions of the lungs where the gas cannot reach after being inhaled due to restrictions of the airways.

    Time frame: up to 2 years

Secondary outcomes

  1. oxygen partial pressure (PAO2) maps

    Oxygen partial pressure (PAO2) maps will be extracted from 129Xe MRI maps in a single breath-hold. Regions of the lungs that show abnormal PAO2 values are susceptible of improper ventilation or gas exchange.

    Time frame: up to 2 years

  2. Forced vital capacity (FVC)

    Forced vital capacity will be extracted from the computer-automated dynamic lung MRI software.

    Time frame: up to 2 years

  3. Forced expiratory volume (FEV1)

    Forced expiratory volume data will be extracted from the computer-automated dynamic lung MRI software to assess the volume of air forced from the lungs

    Time frame: up to 2 years

  4. Xenon-129 MRI apparent diffusion coefficient (ADC) maps

    Apparent diffusion coefficient (ADC) maps are extracted from the Xenon-129 MRI from a single breath-hold pulse sequence.

    Time frame: up to 2 years

  5. total lung capacity

    Total lung capacity will be extracted from the computer-automated dynamic lung MRI software.

    Time frame: up to 2 years

  6. functional residual capacity (FRC)

    functional residual capacity data will be extracted from the computer-automated dynamic lung MRI software to measure the volume in the lungs at the end of passive expiration

    Time frame: up to 2 years

07

Study locations

1 site
  • Children's Hospital of Philadelphia
    Philadelphia, Pennsylvania 19104, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04977830
Lead sponsor
Patrick Cahill, MD
Collaborators
Xemed LLC
Responsible party
Patrick Cahill, MD (Attending physician, Children's Hospital of Philadelphia) — Sponsor-investigator
First posted
Jul 27, 2021
Start date
Jan 2026 (estimated)
Primary completion
Aug 30, 2026 (estimated)
Completion
Aug 30, 2026 (estimated)
Last update
Mar 5, 2026

Study contacts

Patrick Cahill, MD
principal investigator · Children's Hopsital of Philadelphia

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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