Trial record 11 of 30 for:    Cystic Fibrosis | Open Studies | NIH, U.S. Fed

Comparing Chest Images From MRI to CT in Patients With Cystic Fibrosis (CF)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Children's Hospital Medical Center, Cincinnati
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier:
NCT01860872
First received: May 15, 2013
Last updated: July 14, 2014
Last verified: December 2013
  Purpose

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) using an intravenous (IV) contrast dye called gadolinium. The research also includes lung tests called spirometry and blood samples to look at inflammation.

For the CF subjects, enrollment will be timed to coincide with routine scheduled computerized tomography (CT). The MRI will be compared to CT images of the lungs. The goal is to develop better imaging that does not use radiation.


Condition
Cystic Fibrosis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Study of Cardiac MRI to Assess Pulmonary Perfusion and Pulmonary Hemodynamics in Patients With Cystic Fibrosis Study (Pilot 3)

Resource links provided by NLM:


Further study details as provided by Children's Hospital Medical Center, Cincinnati:

Primary Outcome Measures:
  • Cardiopulmonary MRI and CT [ Time Frame: Baseline (MRI and CT acquisition) ] [ Designated as safety issue: No ]
    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.


Biospecimen Retention:   Samples With DNA

serum


Estimated Enrollment: 48
Study Start Date: April 2013
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
CF Group
Cystic Fibrosis group will have MRI at time of clinically ordered CT of chest
Control group
Non-CF controls

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. MRI will be performed with gadolinium 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. Other study procedures include pulmonary function tests (PFT) and blood specimen for serum biomarkers. Specimens will be analyzed for a panel of inflammatory markers.

  Eligibility

Ages Eligible for Study:   8 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Cycstic Fibrosis and Non-CF Controls

Criteria

Inclusion Criteria:

  • Age 8 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

Exclusion Criteria:

  • History of CF-related liver disease with portal hypertension
  • Current cigarette smoking
  • Use of daytime oxygen supplementation
  • Previous organ transplantation
  • Unstable or uncontrolled hypertension
  • Ongoing use of oral corticosteroids
  • Pregnancy (a negative serum pregnancy will be performed for all women of childbearing potential within 7 days of imaging) or lactation
  • Any hemodynamically significant congenital or acquired cardiac disease or significant cardiomyopathy, hematologic disease (i.e. hemoglobinopathies), or pulmonary disease associated with an increased risk of pulmonary perfusion defects or pulmonary hypertension other than as an outcome of CF
  • Subjects with a history of renal and/or hepatic insufficiency
  • Subjects with history of uncontrolled asthma
  • 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.)
  • Daily use of montelukast and ibuprofen
  • Inability to comply with study procedures
  • Positive sputum, epiglottic, or bronchoalveolar lavage culture for Mycobacterium abscessus during the 2 years prior to enrollment
  • Serum creatinine > two times the upper limit of normal for age
  • Serum Cystatin C outside of normal range of 0.530-0.950 mg
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01860872

Contacts
Contact: Lorrie Duan,, RN 513-636-7089 lorrie.duan@cchmc.org

Locations
United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Lorrie Duan, RN         
Principal Investigator: John Clancy, MD         
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Investigators
Principal Investigator: John Clancy, MD Children's Hospital Medical Center, Cincinnati
  More Information

No publications provided

Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT01860872     History of Changes
Other Study ID Numbers: CIN001-CF MRI, 1R01HL116226-01
Study First Received: May 15, 2013
Last Updated: July 14, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital Medical Center, Cincinnati:
Cystic Fibrosis
Pulmonary perfusion
Inflammatory markers
MRI

Additional relevant MeSH terms:
Cystic Fibrosis
Fibrosis
Digestive System Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Lung Diseases
Pancreatic Diseases
Pathologic Processes
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 21, 2014