CompletedNot Applicable

Real-Time Assessment of Lung Structure and Function in Children and Young Adults With CF Using Electrical Impedance Tomography

United States48 participantsStarted 2022-08-01

Plain-language summary

The purpose of this study is to determine the ability of electrical impedance tomography (EIT) to identify structural and functional physiological changes that occur with disease progression in cystic fibrosis patients. The investigators also aim to determine whether EIT can serve as an alternative for CT to identify regions of air trapping and consolidation, whether EIT can provide clinically useful information about response to treatment for an acute PE, and whether EIT can provide longitudinal information about structural changes in the lung.

Who can participate

Age range

3 Years – 21 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: Cohort 1: * Age 3-21 years * Male or female * Healthy subjects with no known or suspected chronic or temporary lung disease Cohort 2: * Age 3-21 years * Male or female * CF as diagnosed based on sweat chloride value(\>60 mmol/L) or two known disease causing mutations Cohort 3: * Age 3-21 years * Male or female * CF as diagnosed based on sweat chloride value (\>60 mmol/L) or two known disease causing mutations * Experiencing a protocol defined pulmonary exacerbation and being started on oral or intravenous antibiotics Exclusion Criteria: * Unwilling/refusal to sign consent * Known congenital heart disease, arrhythmia, or history of heart failure * Wearing a pacemaker or a metallic surgical implant in the chest * History of infection with Burkholderia cepacia * Developmental delays that could result in an inability to complete study procedures

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Identification of air trapping and consolidation by EIT

Timeframe: 36 months

Trial details

NCT IDNCT05455671

SponsorUniversity of Colorado, Denver

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-08-20

View on ClinicalTrials.gov More Cystic Fibrosis trials