Pulmonary Assessment in Thoracic Insufficiency Syndrome Patients

NCT ID: NCT04977830

Last Updated: 2025-05-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-31

Study Completion Date

2026-08-30

Brief Summary

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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.

Detailed Description

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Conditions

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Thoracic Insufficiency Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Thoracic Insufficiency Group

Thoracic insufficiency syndrome patients undergoing surgery

Group Type OTHER

Xenon-129

Intervention Type DEVICE

Patients will undergo a hyperpolarized MRI with administered Xenon gas

Interventions

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Xenon-129

Patients will undergo a hyperpolarized MRI with administered Xenon gas

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* patients not diagnosed with thoracic insufficiency syndrome
Minimum Eligible Age

6 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xemed LLC

INDUSTRY

Sponsor Role collaborator

Patrick Cahill, MD

OTHER

Sponsor Role lead

Responsible Party

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Patrick Cahill, MD

Attending physician

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Patrick Cahill, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hopsital of Philadelphia

Locations

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Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Central Contacts

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Samantha Gogel

Role: CONTACT

267-426-5433

Facility Contacts

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Samantha Gogel

Role: primary

267-426-5433

Other Identifiers

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20-017344

Identifier Type: -

Identifier Source: org_study_id

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