Recruiting

Pulmonary Neutrophil Activity

Sponsor:

National Center for Research Resources (NCRR)

Code:

NCT00023465

Conditions

Cystic Fibrosis

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

FDG-PET

spirometry

bronchoscopy with BAL

Study Details

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

Study ID

NCT00023465

Status verified date

Dec, 2003

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion criteria:

1. Subject has Cystic Fibrosis
2. Subject must be capable of lying still and supine within the PET scanner for approximately 90 minutes.
3. Subject must be capable of fasting for 6 hours
4. 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.
5. Subjects in study 2 must be willing to return within 4 weeks for re-evaluation upon convalescence.
6. The treating physician has granted verbal permission for patient to participate in this study.
7. Subjects in study 2 will have had spirometry upon admission.

Exclusion Criteria:

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

Study Design

Enrollment

10 participants

Interventions and Outcome Measures

Interventions

FDG-PET

spirometry

bronchoscopy with BAL

Central Contacts and Locations

Locations

Washington University School of Medicine

Recruiting

Saint Louis, Missouri, United States, 63110

Contacts

Daniel P. Schuster, MD

314-362-3776schusted@msnotes.wustl.edu

Principal Investigator:

Daniel P. Schuster, MD

More Information

Sponsor

National Center for Research Resources (NCRR)

Last update posted

Jun 24, 2005

Last verified

Dec, 2003

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by National Center for Research Resources (NCRR) on 2005-06-24.