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

NCT01860872 | Completed

• 2 other identifiers: CIN001-CF MRI1R01HL116226-01
• Study Type: observational
• Target: 64
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Cystic Fibrosis

Keywords

Cystic Fibrosis; Pulmonary perfusion; Inflammatory markers; MRI; CT of chest; Lung Clearance Index

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline (MRI and CT acquisition)

Study Arms (3)

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

Eligibility Criteria

• Age: 5 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Cystic Fibrosis and Non-CF Controls

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

serum

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Officials

• John Clancy, MD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2013
• First Posted: May 23, 2013
• Study Start: April 1, 2013
• Primary Completion: December 1, 2018
• Study Completion: April 1, 2019
• Last Updated: July 24, 2020

Record last verified: 2018-04

Locations

US (1)