Thoracic Insufficiency SyndromeNCT04977830
Pulmonary Assessment in Thoracic Insufficiency Syndrome Patients
A study testing Xenon-129 in people with Thoracic Insufficiency Syndrome, run by Patrick Cahill, MD at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Thoracic Insufficiency Syndrome
- What is being tested?
- Xenon-129
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2026to 30 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Males or females 6 to 18 years old diagnosed with thoracic insufficiency syndrome who are undergoing surgery
Who cannot join
- patients not diagnosed with thoracic insufficiency syndrome
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
Official title: New Strategies for Pulmonary Assessment in Spinal and Chest Wall Deformity
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.
- Conditions
- Thoracic Insufficiency Syndrome
- Being tested
- Xenon-129
- Keywords
- Hyperpolarized MRI, Dynamic Lung MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xenon-129Device
Patients will undergo a hyperpolarized MRI with administered Xenon gas
| Study group | Role | What they receive |
|---|---|---|
| Thoracic Insufficiency Group | Other | Thoracic insufficiency syndrome patients undergoing surgery Receives: Device: Xenon-129 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: up to 2 years
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.
Measured: up to 2 years
Secondary outcomes (6)
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.
Measured: up to 2 years
Forced vital capacity (FVC)
Forced vital capacity will be extracted from the computer-automated dynamic lung MRI software.
Measured: up to 2 years
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
Measured: up to 2 years
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.
Measured: up to 2 years
total lung capacity
Total lung capacity will be extracted from the computer-automated dynamic lung MRI software.
Measured: up to 2 years
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
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2021
- Study startJan 2026 (estimated)
- Primary completion30 Aug 2026 (estimated)
- Study completion30 Aug 2026 (estimated)
Why it stopped: Discontinued relationship with vendor. Currently investigating alternatives.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic Insufficiency SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Patrick Cahill, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Xemed LLC
- Responsible party
- Sponsor-investigator, Patrick Cahill, MD, Children's Hospital of Philadelphia
- Investigators
- Patrick Cahill, MD, Principal investigator, Children's Hopsital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04977830
- Sponsor's protocol ID
- 20-017344
- Status last verified
- Mar 2026
- First submitted
- 14 Jul 2021
- Last updated
- 5 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Strategies for Pulmonary Assessment in Spinal and Chest Wall Deformity
- ClinicalTrials.gov ID
- NCT04977830
- Acronym / sponsor ID
- 20-017344
- Conditions
- Thoracic Insufficiency Syndrome
- Keywords
- Hyperpolarized MRI, Dynamic Lung MRI
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Discontinued relationship with vendor. Currently investigating alternatives.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Patrick Cahill, MDUniversity, hospital or other
- Collaborators
- Xemed LLC
- Study start
- Jan 2026 (estimated)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 27 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Thoracic Insufficiency Group | Other | Device: Xenon-129Thoracic insufficiency syndrome patients undergoing surgery |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Males or females 6 to 18 years old diagnosed with thoracic insufficiency syndrome who are undergoing surgery
Key exclusion criteria (1 listed)
- patients not diagnosed with thoracic insufficiency syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Xenon-129Patients will undergo a hyperpolarized MRI with administered Xenon gas | Device | Thoracic Insufficiency Group |
Primary outcome
Analyze volume of lungs at end-inspiration and end-expiration
Time frame: up to 2 years
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)
Xenon-129 MRI Ventilation Maps
Time frame: up to 2 years
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.
6 secondary outcomes
oxygen partial pressure (PAO2) maps
Time frame: up to 2 years
Forced vital capacity (FVC)
Time frame: up to 2 years
Forced expiratory volume (FEV1)
Time frame: up to 2 years
Xenon-129 MRI apparent diffusion coefficient (ADC) maps
Time frame: up to 2 years
total lung capacity
Time frame: up to 2 years
functional residual capacity (FRC)
Time frame: up to 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick Cahill, MD principal investigator
Children's Hopsital of Philadelphia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Xenon-129 in people with Thoracic Insufficiency Syndrome, run by Patrick Cahill, MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analyze volume of lungs at end-inspiration and end-expiration (time frame: up to 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.