Cystic FibrosisNCT01860872
Comparing Chest Images From MRI to CT in Patients With Cystic Fibrosis (CF)
An observational study of Cystic Fibrosis, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
The purpose of this research is to learn more about the heart and blood vessels in the lungs of people with cystic fibrosis (CF). This study will include approximately 36 children and adults with CF and 12 children and adults without CF. The study will involve one magnetic resonance imaging (MRI) . Read more about this study
- Who is it for?
- Ages 5 to 60 years
- Conditions the study is for
- Cystic Fibrosis
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Apr 2019
- 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 5 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Cystic Fibrosis and Non-CF Controls
Who may be able to join
- Age 5 and older
- Diagnosis of cystic fibrosis confirmed by a prior sweat chloride evaluation of > 60 mmol/liter or by two identified CF mutations on genetic analysis; or no CF for controls
- Able to perform acceptable and repeatable spirometry per American Thoracic Society/European Respiratory Society (ATS/ERS) joint consensus criteria.
- If CF, have valid spirometry data for at least 3 years
- If under the age of 18, the patient must assent to participation in the study, and the patient's parent or guardian must be able to give written informed consent and comply with the requirements of the study protocol
- If 18 years of age or older, the patient must be able to give written informed consent and comply with the requirements of the study protocol
- Negative serum pregnancy test (for women of child bearing age)
- Able to tolerate MRI without sedation
Who cannot join
- Pregnancy (a negative serum pregnancy will be performed for all women of childbearing potential within 7 days of imaging) or lactation
- Subjects with a history of renal
- Subjects with a history of hypersensitivity to gadolinium (Magnevist)
- Contraindications specific to MRI including a history of claustrophobia, cardiac pacemaker, or other non-MRI compatible surgical implants (This includes neuro-stimulators containing electrical circuitry, or which generate electrical signals and/or have moving metal parts, and metal orthopedic pins or plates. The research coordinator and/or the MRI technologist will screen all patients using the standard checklist of medical history and safety questions used by the Radiology Department in routine clinical scans.)
- Inability to comply with study procedures
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
Official title: Study of Cardiac MRI to Assess Pulmonary Perfusion and Pulmonary Hemodynamics in Patients With Cystic Fibrosis Study (Pilot 3)
The purpose of this research is to learn more about the heart and blood vessels in the lungs of people with cystic fibrosis (CF). This study will include approximately 36 children and adults with CF and 12 children and adults without CF. The study will involve one magnetic resonance imaging (MRI) . The research also includes blood samples to look at inflammation and lung tests called spirometry and Lung Clearance Index (LCI) determined by Multiple Breath Washout test.
For the CF subjects, enrollment will be timed to coincide with routine scheduled computerized tomography (CT) or the CF subject may choose to have a CT for research purposes. The MRI will be compared to CT images of the lungs. The goal is to develop better imaging that does not use radiation.
Read the detailed description
Cystic Fibrosis (CF), the most common inherited disease in Caucasians, is characterized by chronic pulmonary inflammation and progressive loss of gas exchange units that eventually results in respiratory failure. There is strong evidence that in CF abnormally low vascular perfusion carries a high risk of death independent from the presence of pulmonary hypertension. However, the evolution of pulmonary vascular disease in CF and how it might contribute to the rate of decline in lung function is not known. Knowledge remains limited to the results of old observational studies which concluded that the major causes of pulmonary vascular remodeling and hypertension in CF are hypoxic respiratory failure and destruction of lung tissue. Recent data obtained by state-of-the-art Magnetic Resonance Imaging (MRI) of the pulmonary circulation, challenges the existing paradigm. Studies demonstrate that in the absence of hypoxia, significant changes in pulmonary perfusion and in surrogate measures of vascular resistance as well as in collateral blood flow begin early in the course of CF. The newly developed therapeutics in the last decade which altered dramatically the course of patients suffering from pulmonary vascular disease provide opportunities to understand the role of pulmonary vasculature in CF lung disease.
This pilot study (Pilot 3) will assess the relationships between pulmonary perfusion, serum markers of pulmonary inflammation and vascular remodeling, and hemodynamic measures consistent with pulmonary hypertension. This study will establish MRI as a readily obtainable modality to be used in the CF population to obtain measurements of pulmonary perfusion; pulmonary arterial hemodynamic, dimension, and flow measures; and ventricular mass and function measures.
The primary goal of this study is to improve the understanding of pulmonary vascular disease in CF by examining pulmonary perfusion abnormalities and their association with markers of pulmonary inflammation and pulmonary vascular remodeling, the severity of obstructive airways disease, and pulmonary hemodynamic abnormalities in CF.
This study will include a single MRI of the pulmonary circulation on about 36 pediatric and adult patients with CF and about 12 non-CF controls. UTE (Ultrashort Echo Time) MRI will be performed without contrast. CF patients who are scheduled for clinical chest CT will be enrolled and the scheduling of the MRI will be coordinated with the clinical CT. CF subjects may also choose to enroll independent of clinical CT and choose to have a CT for research purposes only. Other study procedures include blood specimen for serum biomarkers and lung tests called spirometry and Lung Clearance Index (LCI) determined by Multiple Breath Washout test. Blood specimens will be analyzed for a panel of inflammatory markers.
- Conditions
- Cystic Fibrosis
- Keywords
- Cystic Fibrosis, Pulmonary perfusion, Inflammatory markers, MRI, CT of chest, Lung Clearance Index
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| CF Group | Cystic Fibrosis group with MRI and CT of chest | |
| Control group | Non-CF controls will have MRI and no CT of chest | |
| Combined Group | MRI Quality \& Image Relatedness |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiopulmonary MRI and CT
Assess perfusion in each pulmonary segment. Segmental perfusion will be scored on a continuous scale (0=normal, 1=mild abnormality, 2=moderate abnormality, 3=severe abnormality) for each of the 18 lobar segments.
Measured: Baseline (MRI and CT acquisition)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2013 (estimated)
- Study startApr 2013
- Primary completionDec 2018
- Study completionApr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe sponsor's other registered studies.
- 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-control
- Time perspective
- Prospective
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- John Clancy, MD, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01860872
- Sponsor's protocol ID
- CIN001-CF MRI
- Other IDs
- 1R01HL116226-01
- Status last verified
- Apr 2018
- First submitted
- 15 May 2013
- Last updated
- 24 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Cardiac MRI to Assess Pulmonary Perfusion and Pulmonary Hemodynamics in Patients With Cystic Fibrosis Study (Pilot 3)
- ClinicalTrials.gov ID
- NCT01860872
- Acronym / sponsor ID
- CIN001-CF MRI
- Conditions
- Cystic Fibrosis
- Keywords
- Cystic Fibrosis, Pulmonary perfusion, Inflammatory markers, MRI, CT of chest, Lung Clearance Index
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Apr 2013 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Apr 2019 (actual)
- First posted
- 23 May 2013 (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 purpose of this research is to learn more about the heart and blood vessels in the lungs of people with cystic fibrosis (CF). This study will include approximately 36 children and adults with CF and 12 children and adults without CF. The study will involve one magnetic resonance imaging (MRI) . The research also includes blood samples to look at inflammation and lung tests called spirometry and Lung Clearance Index (LCI) determined by Multiple Breath Washout test.
For the CF subjects, enrollment will be timed to coincide with routine scheduled computerized tomography (CT) or the CF subject may choose to have a CT for research purposes. The MRI will be compared to CT images of the lungs. The goal is to develop better imaging that does not use radiation.
Detailed description
Cystic Fibrosis (CF), the most common inherited disease in Caucasians, is characterized by chronic pulmonary inflammation and progressive loss of gas exchange units that eventually results in respiratory failure. There is strong evidence that in CF abnormally low vascular perfusion carries a high risk of death independent from the presence of pulmonary hypertension. However, the evolution of pulmonary vascular disease in CF and how it might contribute to the rate of decline in lung function is not known. Knowledge remains limited to the results of old observational studies which concluded that the major causes of pulmonary vascular remodeling and hypertension in CF are hypoxic respiratory failure and destruction of lung tissue. Recent data obtained by state-of-the-art Magnetic Resonance Imaging (MRI) of the pulmonary circulation, challenges the existing paradigm. Studies demonstrate that in the absence of hypoxia, significant changes in pulmonary perfusion and in surrogate measures of vascular resistance as well as in collateral blood flow begin early in the course of CF. The newly developed therapeutics in the last decade which altered dramatically the course of patients suffering from pulmonary vascular disease provide opportunities to understand the role of pulmonary vasculature in CF lung disease.
This pilot study (Pilot 3) will assess the relationships between pulmonary perfusion, serum markers of pulmonary inflammation and vascular remodeling, and hemodynamic measures consistent with pulmonary hypertension. This study will establish MRI as a readily obtainable modality to be used in the CF population to obtain measurements of pulmonary perfusion; pulmonary arterial hemodynamic, dimension, and flow measures; and ventricular mass and function measures.
The primary goal of this study is to improve the understanding of pulmonary vascular disease in CF by examining pulmonary perfusion abnormalities and their association with markers of pulmonary inflammation and pulmonary vascular remodeling, the severity of obstructive airways disease, and pulmonary hemodynamic abnormalities in CF.
This study will include a single MRI of the pulmonary circulation on about 36 pediatric and adult patients with CF and about 12 non-CF controls. UTE (Ultrashort Echo Time) MRI will be performed without contrast. CF patients who are scheduled for clinical chest CT will be enrolled and the scheduling of the MRI will be coordinated with the clinical CT. CF subjects may also choose to enroll independent of clinical CT and choose to have a CT for research purposes only. Other study procedures include blood specimen for serum biomarkers and lung tests called spirometry and Lung Clearance Index (LCI) determined by Multiple Breath Washout test. Blood specimens will be analyzed for a panel of inflammatory markers.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CF Group | – | –Cystic Fibrosis group with MRI and CT of chest |
| Control group | – | –Non-CF controls will have MRI and no CT of chest |
| Combined Group | – | –MRI Quality \& Image Relatedness |
Who may qualify
- Ages
- 5 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Cystic Fibrosis and Non-CF Controls
Key inclusion criteria (8 listed)
- Age 5 and older
- Diagnosis of cystic fibrosis confirmed by a prior sweat chloride evaluation of > 60 mmol/liter or by two identified CF mutations on genetic analysis; or no CF for controls
- Able to perform acceptable and repeatable spirometry per American Thoracic Society/European Respiratory Society (ATS/ERS) joint consensus criteria.
- If CF, have valid spirometry data for at least 3 years
- If under the age of 18, the patient must assent to participation in the study, and the patient's parent or guardian must be able to give written informed consent and comply with the requirements of the study protocol
Key exclusion criteria (5 listed)
- Pregnancy (a negative serum pregnancy will be performed for all women of childbearing potential within 7 days of imaging) or lactation
- Subjects with a history of renal
- Subjects with a history of hypersensitivity to gadolinium (Magnevist)
- Contraindications specific to MRI including a history of claustrophobia, cardiac pacemaker, or other non-MRI compatible surgical implants (This includes neuro-stimulators containing electrical circuitry, or which generate electrical signals and/or have moving metal parts, and metal orthopedic pins or plates. The research coordinator and/or the MRI technologist will screen all patients using the standard checklist of medical history and safety questions used by the Radiology Department in routine clinical scans.)
- Inability to comply with study procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cardiopulmonary MRI and CT
Time frame: Baseline (MRI and CT acquisition)
Assess perfusion in each pulmonary segment. Segmental perfusion will be scored on a continuous scale (0=normal, 1=mild abnormality, 2=moderate abnormality, 3=severe abnormality) for each of the 18 lobar segments.
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 24 Jul 2020.
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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.
John Clancy, MD principal investigator
Children's Hospital Medical Center, Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystic Fibrosis, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
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 8 inclusion and 5 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 24 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Cardiopulmonary MRI and CT (time frame: Baseline (MRI and CT acquisition)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jul 2020.