Status:
COMPLETED
Comparing Chest Images From MRI to CT in Patients With Cystic Fibrosis (CF)
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
5-60 years
Brief 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 a...
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 respirat...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2019
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT01860872
Start Date
April 1 2013
End Date
April 1 2019
Last Update
July 24 2020
Active Locations (1)
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1
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229