Quantification of Pulmonary Neutrophil Activity in Cystic Fibrosis Using Radiolabeled Fluorodeoxyglucose and PET Imaging
Summary
It has been shown that neutrophils (a specific type of cell) are involved in inflammation in the lungs of CF patients. Neutrophil levels in CF patients have been measured by bronchoalveolar lavage (BAL), which samples cells in the fluid lining of the lungs. Other studies have measured neutrophil levels and inflammation in other parts of the body using PET scanning. This study aims to show that PET scanning can be used as a non-invasive marker of inflammation in the lungs of patients with CF, which would be a useful tool in treatment.
The primary goal of this study is to draw a connection between the level of inflammation shown in the PET scan and the number of neutrophils obtained from the BAL. This study will also look at how the PET images relate to inflammatory molecules in the lungs and to the FEV-1 obtained through spirometry.
Description
All patients involved in the study will have a PET scan performed. This involves injecting a small amount of radiolabelled glucose (sugar) into the blood. A scan will then be performed to obtain an image of where in the body that glucose is being used. Patients will also have spirometry done. Spirometry is a simple procedure measuring the functioning of the lungs (FEV-1) by measuring the amount of air a patient can blow out and inhale (the patient breathes into a machine). Bronchoalveolar lavage (BAL) will be performed. This involves putting a small amount of fluid into a section of the lung, then suctioning it out to retrieve the cells and molecules contained in the substance lining the lung.
Subjects will be patients with cystic fibrosis. Ten subjects will be stable with either mild or moderate disease. These subjects will receive a PET scan, spirometry, and BAL.
This portion of the study is made up of 10 stable CF patients, 5 of whom will have mild disease, and 5 of whom will have moderate disease. These patients will receive a PET scan, spirometry and a BAL over 2 consecutive days. On day 1, patients will have a PET scan and spirometry. On day 2, patients will have a BAL.
Patients will arrive on the first day after fasting for at least 6 hours and will be taken to the PET facility. PET scanning consists of a 2-minute scan followed by a 15-minute scan, injection of radiolabelled sugar into the vein, and 66 minutes of scanning. The patient will then be instructed to empty his or her bladder to reduce total radiation exposure. The patient will then be given a meal. Next, the patient will be taken for spirometry, the last test of day 1, which simple involves breathing into a machine that measures the amount of air inhaled and exhaled. Upon reporting to the GCRC on day 2, the patient will be taken for a BAL (the patient will have fasted for at least 6 hours prior to admission). BAL involves a small tube placed into the mouth, down the throat, and into the lung (lidocaine is used to numb the entire area). Less than 3 tablespoons of saline (salt water) is poured down the tube, then immediately sucked back up and collected by the doctor. This is repeated twice, for a total of 8 tablespoons of liquid.
Study Design
Observational Model: Defined Population, Time Perspective: Longitudinal, Time Perspective: Prospective
Conditions
Cystic Fibrosis
Intervention
FDG-PET, spirometry, bronchoscopy with BAL
Location
Washington University School of Medicine
Saint Louis
Missouri
United States
63110
Status
Recruiting
Source
National Center for Research Resources (NCRR)
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00023465
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Cystic Fibrosis
An autosomal recessive genetic disease of the EXOCRINE GLANDS. It is caused by mutations in the gene encoding the CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR expressed in several organs including the LUNG, the PANCREAS, the BILIARY SYSTEM, and the SWEAT GLANDS. Cystic fibrosis is characterized by epithelial secretory dysfunction associated with ductal obstruction resulting in AIRWAY OBSTRUCTION; chronic RESPIRATORY INFECTIONS; PANCREATIC INSUFFICIENCY; maldigestion; salt depletion; and HEAT PROSTRATION.
Cystic Fibrosis Transmembrane Conductance Regulator
A chloride channel that regulates secretion in many exocrine tissues. Abnormalities in the CFTR gene have been shown to cause cystic fibrosis. (Hum Genet 1994;93(4):364-8)
Mice, Inbred Cftr
A strain of mice widely studied as a model for cystic fibrosis. These mice are generated from embryonic stem cells in which the CFTR (cystic fibrosis transmembrane conductance regulator) gene is inactivated by gene targeting. As a result, all mice have one copy of this altered gene in all their tissues. Mice homozygous for the disrupted gene exhibit many features common to young cystic fibrosis patients, including failure to thrive, meconium ileus, and alteration of mucous and serous glands.
Stenotrophomonas Maltophilia
A species of STENOTROPHOMONAS, formerly called Xanthomonas maltophilia, which reduces nitrate. It is a cause of hospital-acquired ocular and lung infections, especially in those patients with cystic fibrosis and those who are immunosuppressed.
Drainage, Postural
A rehabilitation therapy for removal of copious mucus secretion from the lung of patients with diseases such as CHRONIC BRONCHITIS; BRONCHIECTASIS; PULMONARY ABSCESS; or CYSTIC FIBROSIS. The patient's head is placed in a downward incline (so the TRACHEA is inferior to the affected area) for 15- to 20-minute sessions.
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