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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Observational
Eligible Ages 3 Years - 21 Years
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT05455671
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 University of Colorado, Denver
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Jordana Jordana, MD
Principal Investigator Affiliation Children's Hospital Colorado
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Cystic Fibrosis, Healthy
Arms & Interventions

Arms

: Cohort 1 - Healthy Controls

Persons, male or female, between the ages of 3 and 21 (inclusive) with healthy lungs, defined by no known or suspected chronic or temporary lung disease. A single study visit

: Cohort 2 - CF Longitudinal

Persons, male or female, with CF, defined by two known disease-causing mutations and/or a sweat chloride value of >60mmol/L, between the ages of 3 and 21 (inclusive).

: Cohort 3 - CF Exacerbation

Persons, male or female, with CF, defined by two known disease-causing mutations and/or a sweat chloride value of >60mmol/L, between the ages of 3 and 21 (inclusive), experiencing a pulmonary exacerbation requiring antibiotics.

Interventions

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Children's Hospital Colorado, Aurora, Colorado

Status

Recruiting

Address

Children's Hospital Colorado

Aurora, Colorado, 80045

Site Contact

Jordana Hoppe, MD

[email protected]

720-777-6550

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