NCT04977830

Brief 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.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
4mo left

Started Jan 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress53%
Jan 2026Aug 2026

First Submitted

Initial submission to the registry

July 14, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 27, 2021

Completed
4.4 years until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2026

Last Updated

March 5, 2026

Status Verified

March 1, 2026

Enrollment Period

8 months

First QC Date

July 14, 2021

Last Update Submit

March 3, 2026

Conditions

Thoracic Insufficiency Syndrome

Keywords

Hyperpolarized MRIDynamic Lung MRI

Outcome Measures

Primary Outcomes (2)

  • 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)

    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.

    up to 2 years

Secondary Outcomes (6)

  • oxygen partial pressure (PAO2) maps

    up to 2 years

  • Forced vital capacity (FVC)

    up to 2 years

  • Forced expiratory volume (FEV1)

    up to 2 years

  • Xenon-129 MRI apparent diffusion coefficient (ADC) maps

    up to 2 years

  • total lung capacity

    up to 2 years

  • +1 more secondary outcomes

Study Arms (1)

Thoracic Insufficiency Group

OTHER

Thoracic insufficiency syndrome patients undergoing surgery

Device: Xenon-129

Interventions

Xenon-129DEVICE

Patients will undergo a hyperpolarized MRI with administered Xenon gas

Thoracic Insufficiency Group

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • patients not diagnosed with thoracic insufficiency syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Study Officials

  • Patrick Cahill, MD

    Children's Hopsital of Philadelphia

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Attending physician

Study Record Dates

First Submitted

July 14, 2021

First Posted

July 27, 2021

Study Start

January 1, 2026

Primary Completion (Estimated)

August 30, 2026

Study Completion (Estimated)

August 30, 2026

Last Updated

March 5, 2026

Record last verified: 2026-03

Locations

US(1)