Cystic FibrosisNCT02524704
Electrical Impedance Imaging of Patients With Cystic Fibrosis
An observational study of Cystic Fibrosis, run by Colorado State University.
Trial summary
The goal of this feasibility study is to evaluate the ability of Electrical Impedance Tomography (EIT) for providing regional and quantitative information about the extent and nature of bronchial obstruction in patients with cystic fibrosis. Read more about this study
- Who is it for?
- Ages 2 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- CT scan
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- Mar 2015to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: There are three groups in this study. Group 1 consists of healthy controls between the ages of 2 and 21. Group 2 consists of persons with cystic fibrosis between the ages of 2 and 21 who are either clinically indicated for a pulmonary CT scan or will receive one as part of their routine care. Group 3 consists of persons with cystic fibrosis between the ages of 8 and 21 who are being started on IV antibiotics for a clinically diagnosed pulmonary exacerbation. Sampling is by convenience or invitation to volunteer.
Who may be able to join
- Between the ages of 2 and 21 years (Groups 1 and 2)
- Between the ages of 8 and 21 years (Group 3)
- Healthy lungs (Group 1)
- Clinical diagnosis of cystic fibrosis (Groups 2 and 3)
- Clinically indicated for a pulmonary CT scan or will receive one as part of their routine care (Group 2)
- Receiving IV antibiotics for a clinically diagnosed pulmonary exacerbation (Group 3)
Who cannot join
- Under age 24 months or over age 21.
- No informed consent
- Known congenital heart disease, arrythmia, or history of heart failure, admission to the intensive care unit, wearing a pacemaker or other surgical implant.
- Pregnant or lactating
About this study
Official title: Electrical Impedance Tomography (EIT): A Non-radiating Functional Imaging for Cystic Fibrosis
The goal of this feasibility study is to evaluate the ability of Electrical Impedance Tomography (EIT) for providing regional and quantitative information about the extent and nature of bronchial obstruction in patients with cystic fibrosis. It is not being conducted to diagnose, treat, prevent, or cure any kind of disease. In electrical impedance tomography low amplitude, low frequency current is applied on electrodes, and the resulting voltage is measured and used to computed the electrical properties of the interior of the chest as they change in time. The computed properties are used to form an image, which can then be used for monitoring and diagnosis.
Read the detailed description
The goal of this study is to evaluate the ability of Electrical Impedance Tomography (EIT) hardware and software in patients with cystic fibrosis (CF) for providing regional and quantitative information for identifying regions of obstruction and consolidation, and determine whether these measures will correlate with improvements seen after hospitalized treatment for a pulmonary exacerbation (PE). In particular, EIT will be used to identify regions of obstruction (air trapping) and consolidation comprised of atelectasis and airway occlusion (consequences of mucus plugging) in CF patients, and to determine whether EIT can demonstrate the beneficial effects of antibiotic treatment for CF patients with an acute PE by correlating changes in quantitative EIT measures with clinical measures known to improve following therapy, with patients serving as their own controls. Regional changes in air trapping and consolidation from pre to post treatment as indicated by the EIT images will be calculated, with subjects serving as their own control.
- Conditions
- Cystic Fibrosis
- Being tested
- CT scan
- Keywords
- Cystic fibrosis, Electrical Impedance Tomography
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT scanDevice
Applied only when part of the patient's standard care
| Study group | Role | What they receive |
|---|---|---|
| Healthy controls | Subjects between the ages of 2 and 21 with healthy lungs. Electrical impedance tomography data will be collected during tidal breathing, during 5 to 10 seconds of breath holding, and during FEV1 and FEF 25-75 spirometry maneuvers for subjects over age 8. | |
| CF patients scheduled for a CT scan | Subjects with CF between the ages of 2 and 21 who are either clinically indicated for a CT scan of the lungs or are scheduled for a pulmonary CT scan as part of their routine care. Electrical impedance tomography data data will be collected during tidal breathing, during 5 to 10 seconds of breath holding, during forced expiratory volume in 1 second (FEV1) and forced expiratory flow (FEF) 25-75 spirometry maneuvers for subjects over age 8, and immediately before or after pulmonary CT scanning. Receives: Device: CT scan | |
| CF patients with pulmonary exacerbation | Subjects with CF between the ages of 8 and 21 who are being started on intravenous (IV) antibiotics for a clinically diagnosed pulmonary exacerbation.
Electrical impedance tomography data data will be collected during tidal breathing, during 5 to 10 seconds of breath holding, during FEV1 and FEF 25-75 spirometry maneuvers upon admission for a pulmonary exacerbation and following 7 to 14 days hospitalized treatment including IV antibiotics. Further data will be collected at the same time with CT scanning if the scan is part of the patient's standard of care. Receives: Device: CT scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity for identifying air trapping and consolidation
The sensitivity and specificity of EIT for identifying regions of air trapping and consolidation will be assessed using the CT scan as the gold standard
Measured: 2 years
Secondary outcomes (2)
Accuracy of the EIT computed spirometry values
The accuracy of the spirometry measures computed from EIT images will be assessed by comparing to those from the pulmonary function tests
Measured: 2 years
Correlation of EIT derived measures to patient improvement following IV antibiotics
Changes in quantitative EIT measures will be correlated with clinical measures known to improve following therapy, patients serving as their own controls.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2015 (estimated)
- Study startMar 2015
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Colorado State University
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital Colorado, University of Colorado, Denver
- Responsible party
- Sponsor
- Investigators
- Jennifer L Mueller, PhD, Principal investigator, Colorado State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02524704
- Sponsor's protocol ID
- ColoradoSU
- Status last verified
- Jul 2016
- First submitted
- 7 Aug 2015
- Last updated
- 17 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hamilton SJ, Mueller JL. Direct EIT reconstructions of complex admittivities on a chest-shaped domain in 2-D. IEEE Trans Med Imaging. 2013 Apr;32(4):757-69. doi: 10.1109/TMI.2012.2237389. Epub 2013 Jan 9.
PubMed 23314771Herrera CN, Vallejo MF, Mueller JL, Lima RG. Direct 2-D reconstructions of conductivity and permittivity from EIT data on a human chest. IEEE Trans Med Imaging. 2015 Jan;34(1):267-74. doi: 10.1109/TMI.2014.2354333. Epub 2014 Sep 4.
PubMed 25203984
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrical Impedance Tomography (EIT): A Non-radiating Functional Imaging for Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT02524704
- Acronym / sponsor ID
- ColoradoSU
- Conditions
- Cystic Fibrosis
- Keywords
- Cystic fibrosis, Electrical Impedance Tomography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Colorado State UniversityUniversity, hospital or other
- Collaborators
- Children's Hospital Colorado, University of Colorado, Denver
- Study start
- Mar 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 17 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this feasibility study is to evaluate the ability of Electrical Impedance Tomography (EIT) for providing regional and quantitative information about the extent and nature of bronchial obstruction in patients with cystic fibrosis. It is not being conducted to diagnose, treat, prevent, or cure any kind of disease. In electrical impedance tomography low amplitude, low frequency current is applied on electrodes, and the resulting voltage is measured and used to computed the electrical properties of the interior of the chest as they change in time. The computed properties are used to form an image, which can then be used for monitoring and diagnosis.
Detailed description
The goal of this study is to evaluate the ability of Electrical Impedance Tomography (EIT) hardware and software in patients with cystic fibrosis (CF) for providing regional and quantitative information for identifying regions of obstruction and consolidation, and determine whether these measures will correlate with improvements seen after hospitalized treatment for a pulmonary exacerbation (PE). In particular, EIT will be used to identify regions of obstruction (air trapping) and consolidation comprised of atelectasis and airway occlusion (consequences of mucus plugging) in CF patients, and to determine whether EIT can demonstrate the beneficial effects of antibiotic treatment for CF patients with an acute PE by correlating changes in quantitative EIT measures with clinical measures known to improve following therapy, with patients serving as their own controls. Regional changes in air trapping and consolidation from pre to post treatment as indicated by the EIT images will be calculated, with subjects serving as their own control.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy controls | – | –Subjects between the ages of 2 and 21 with healthy lungs. Electrical impedance tomography data will be collected during tidal breathing, during 5 to 10 seconds of breath holding, and during FEV1 and FEF 25-75 spirometry maneuvers for subjects over age 8. |
| CF patients scheduled for a CT scan | – | Device: CT scanSubjects with CF between the ages of 2 and 21 who are either clinically indicated for a CT scan of the lungs or are scheduled for a pulmonary CT scan as part of their routine care. Electrical impedance tomography data data will be collected during tidal breathing, during 5 to 10 seconds of breath holding, during forced expiratory volume in 1 second (FEV1) and forced expiratory flow (FEF) 25-75 spirometry maneuvers for subjects over age 8, and immediately before or after pulmonary CT scanning. |
| CF patients with pulmonary exacerbation | – | Device: CT scanSubjects with CF between the ages of 8 and 21 who are being started on intravenous (IV) antibiotics for a clinically diagnosed pulmonary exacerbation. Electrical impedance tomography data data will be collected during tidal breathing, during 5 to 10 seconds of breath holding, during FEV1 and FEF 25-75 spirometry maneuvers upon admission for a pulmonary exacerbation and following 7 to 14 days hospitalized treatment including IV antibiotics. Further data will be collected at the same time with CT scanning if the scan is part of the patient's standard of care. |
Who may qualify
- Ages
- 2 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- There are three groups in this study. Group 1 consists of healthy controls between the ages of 2 and 21. Group 2 consists of persons with cystic fibrosis between the ages of 2 and 21 who are either clinically indicated for a pulmonary CT scan or will receive one as part of their routine care. Group 3 consists of persons with cystic fibrosis between the ages of 8 and 21 who are being started on IV antibiotics for a clinically diagnosed pulmonary exacerbation. Sampling is by convenience or invitation to volunteer.
Key inclusion criteria (6 listed)
- Between the ages of 2 and 21 years (Groups 1 and 2)
- Between the ages of 8 and 21 years (Group 3)
- Healthy lungs (Group 1)
- Clinical diagnosis of cystic fibrosis (Groups 2 and 3)
- Clinically indicated for a pulmonary CT scan or will receive one as part of their routine care (Group 2)
Key exclusion criteria (4 listed)
- Under age 24 months or over age 21.
- No informed consent
- Known congenital heart disease, arrythmia, or history of heart failure, admission to the intensive care unit, wearing a pacemaker or other surgical implant.
- Pregnant or lactating
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT scanApplied only when part of the patient's standard care | Device | CF patients scheduled for a CT scan, CF patients with pulmonary exacerbation |
Primary outcome
Sensitivity and specificity for identifying air trapping and consolidation
Time frame: 2 years
The sensitivity and specificity of EIT for identifying regions of air trapping and consolidation will be assessed using the CT scan as the gold standard
2 secondary outcomes
Accuracy of the EIT computed spirometry values
Time frame: 2 years
Correlation of EIT derived measures to patient improvement following IV antibiotics
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2018.
- Background: PubMed 23314771Hamilton SJ, Mueller JL. Direct EIT reconstructions of complex admittivities on a chest-shaped domain in 2-D. IEEE Trans Med Imaging. 2013 Apr;32(4):757-69. doi: 10.1109/TMI.2012.2237389. Epub 2013 Jan 9.
- Background: PubMed 25203984Herrera CN, Vallejo MF, Mueller JL, Lima RG. Direct 2-D reconstructions of conductivity and permittivity from EIT data on a human chest. IEEE Trans Med Imaging. 2015 Jan;34(1):267-74. doi: 10.1109/TMI.2014.2354333. Epub 2014 Sep 4.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer L Mueller, PhD principal investigator
Colorado State University
Questions about this trial
What is this clinical trial studying?
An observational study of Cystic Fibrosis, run by Colorado State University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity for identifying air trapping and consolidation (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02524704, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2018.