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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00023465
• Date of registration: 06/09/2001
• Prospective Registration: No
• Primary sponsor: National Center for Research Resources (NCRR)
• Public title: Quantification of Pulmonary Neutrophil Activity in Cystic Fibrosis Using Radiolabeled Fluorodeoxyglucose and PET Imaging
• Scientific title: Quantification of Pulmonary Neutrophil Activity in Cystic Fibrosis Using Radiolabeled Fluorodeoxyglucose and PET Imaging
• Date of first enrolment: June 2001
• Target sample size: 10
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT00023465
• Study type: Observational
• Study design: Observational Model: Defined Population, Time Perspective: Longitudinal
• Phase: N/A

Countries of recruitment

United States

Contacts

• Name: Daniel P. Schuster, MD

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Cystic Fibrosis

Intervention(s)

Procedure: bronchoscopy with BAL

Procedure: FDG-PET

Procedure: spirometry

Secondary ID(s)

NCRR-MO1RR00036-0798

Source(s) of Monetary Support

Please refer to primary and secondary sponsors