Quantification of Pulmonary Neutrophil Activity in Cystic Fibrosis Using Radiolabeled Fluorodeoxyglucose and PET Imaging

NCT00023465 | Unknown

• 1 other identifier: NCRR-MO1RR00036-0798
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cystic Fibrosis

Interventions

FDG-PET PROCEDURE

spirometry PROCEDURE

bronchoscopy with BAL PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject has Cystic Fibrosis
• Subject must be capable of lying still and supine within the PET scanner for approximately 90 minutes.
• Subject must be capable of fasting for 6 hours
• Subjects must fall into one of the following three categories: Study 1 Group A: Stable Patient with mild CF. Must have an FEV1 of greater than 65% predicted. Study 1 Group B: Stable Patient with moderate/moderately severe CF. Must have an FEV1 of between 40% and 65% predicted. Study 2: Acutely Ill Patient: CF patient admitted to the hospital with acute exacerbation of obstructive lung disease associated with CF, requiring hospitalization.
• Subjects in study 2 must be willing to return within 4 weeks for re-evaluation upon convalescence.
• The treating physician has granted verbal permission for patient to participate in this study.
• Subjects in study 2 will have had spirometry upon admission.

You may not qualify if:

• Failure to obtain informed consent.
• Pregnancy (confirmed by a qualitative urine hCG pregnancy test)
• Lactation
• Subject is enrolled in another study involving the use of radioisotopes or another research study of an investigational drug
• For subjects in groups 1A and 1B, inability to tolerate BAL (ie, medically unstable)
• Diagnosis of diabetes or fasting blood sugar \>150 mg/dl
• Study 1: FEV1 \<40% predicted
• Study 2: baseline (prehospitalization) FEV1 \<40% predicted
• Patient requires mechanical ventilation
• Patient has received G-CSF (granulocyte colony stimulating factor) within the last 5 days

Sponsors & Collaborators

• National Center for Research Resources (NCRR): lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

RECRUITING

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Bronchoscopy

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

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Pulmonary Surgical Procedures; Thoracic Surgical Procedures

Study Design

• Study Type: observational
• Observational Model: DEFINED POPULATION
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH

Study Record Dates

• First Submitted: September 6, 2001
• First Posted: September 10, 2001
• Last Updated: June 24, 2005

Record last verified: 2003-12

Locations

US (1)