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Xenon-129 MRI for Thoracic Insufficiency Syndrome

N/A
Recruiting
Led By Patrick Cahill, MD
Research Sponsored by Children's Hospital of Philadelphia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Males or females 6 to 18 years old diagnosed with thoracic insufficiency syndrome who are undergoing surgery
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Study Summary

This trial is testing whether MRI can be used to measure how well a person's lungs are working, in order to help manage a condition called Thoracic Insufficiency Syndrome.

Who is the study for?
This trial is for boys and girls aged 6 to 18 who have been diagnosed with Thoracic Insufficiency Syndrome (TIS) and are scheduled for surgery. It's not open to those without a TIS diagnosis.Check my eligibility
What is being tested?
The study is testing the use of Xenon-129 in MRI imaging sequences as a new way to assess lung function in patients with TIS, which often includes chest wall deformities and spine disorders like scoliosis.See study design
What are the potential side effects?
Since this trial focuses on validating an imaging technique rather than a medication or surgical procedure, direct side effects from Xenon-129 used in MRI scans are minimal but may include discomfort during the scan.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 6 and 18 years old and will have surgery for thoracic insufficiency syndrome.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Analyze volume of lungs at end-inspiration and end-expiration
Xenon-129 MRI Ventilation Maps
Secondary outcome measures
Forced expiratory volume (FEV1)
Forced vital capacity (FVC)
Xenon-129 MRI apparent diffusion coefficient (ADC) maps
+3 more

Side effects data

From 2020 Phase 3 trial • 38 Patients • NCT03417687
7%
Pruritus
7%
Hematemesis
7%
Hypoaesthesia oral
7%
Hair disorder
7%
Erythema
7%
Intestinal pseudo-obstruction
7%
Lacrimation increased
7%
Colitis
7%
Nausea
7%
Eye pruritus
7%
Restlessness
7%
Skin discolouration
100%
80%
60%
40%
20%
0%
Study treatment Arm
129Xe Before 133Xe
133Xe Before 129Xe

Trial Design

1Treatment groups
Experimental Treatment
Group I: Thoracic Insufficiency GroupExperimental Treatment1 Intervention
Thoracic insufficiency syndrome patients undergoing surgery

Find a Location

Who is running the clinical trial?

Children's Hospital of PhiladelphiaLead Sponsor
708 Previous Clinical Trials
8,581,298 Total Patients Enrolled
Patrick Cahill, MDPrincipal InvestigatorChildren's Hopsital of Philadelphia
1 Previous Clinical Trials
20 Total Patients Enrolled

Media Library

Thoracic Insufficiency Group Clinical Trial Eligibility Overview. Trial Name: NCT04977830 — N/A
Thoracic Insufficiency Syndrome Research Study Groups: Thoracic Insufficiency Group
Thoracic Insufficiency Syndrome Clinical Trial 2023: Thoracic Insufficiency Group Highlights & Side Effects. Trial Name: NCT04977830 — N/A
Thoracic Insufficiency Group 2023 Treatment Timeline for Medical Study. Trial Name: NCT04977830 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it possible to enlist in this clinical research effort?

"This medical trial seeks 5 participants, aged between 6 and 18 years old, who have been medically diagnosed with thoracic insufficiency syndrome. Both male and female patients are eligible for the study if they meet these criteria and are undergoing surgery."

Answered by AI

What is the total number of participants in this investigation?

"Affirmative. According to the data posted on clinicaltrials.gov, this medical experiment is recruiting subjects as of October 4th 2022; it was initially launched on 1st October 2022. The investigation requires 5 participants at one location for completion."

Answered by AI

What aims is this research endeavor striving to accomplish?

"The team is primarily interested in observing changes to Xenon-129 MRI Ventilation Maps over a two year period. Secondary objectives include measuring Total Lung Capacity, Forced Expiratory Volume (FEV1), and Oxygen Partial Pressure (PAO2) maps using computer-automated dynamic lung MRI software. These measurements will help the researchers identify regions of the lungs that are not ventilating or exchanging gas properly."

Answered by AI

Are individuals over the age of 45 allowed to join this experiment?

"This clinical trial has specified that candidates should have an age between 6 and 18 years old."

Answered by AI

Are there still opportunities for participants to join this experiment?

"According to the clinicaltrials.gov resource, this research project is actively recruiting patients: it was initially shared on October 1st 2022 and last modified four days later."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Pulmonary Assessment in Thoracic Insufficiency Syndrome Patients
2024. "Pulmonary Assessment in Thoracic Insufficiency Syndrome Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04977830.
~3 spots leftby Aug 2025
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