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N/A N=21 Diagnostic

FDG-PET Imaging in Young Cystic Fibrosis Patients

Cystic Fibrosis

Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Jul 2018
Primary outcome: Primary: Kinetic Influx Constant (Ki) — 0.009; 0.013 mL/min/mL

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
FDG-PET (Diagnostic_test)
Age
Pediatric, Adult · 12+ yrs
Sex
All
Sponsor
Washington University School of Medicine
Primary completion
Feb 2012

Outcome Measures

OutcomeResultp-value
PRIMARY
Kinetic Influx Constant (Ki)
0.009; 0.013
SECONDARY
Sputum Neutrophil Elastase (NE) Concentration
2179; 1656

Summary

The purpose of this research is to determine how a person's lungs will uptake [18F]fluorodeoxyglucose (FDG), as measured with positron emission tomography (PET) scanning in young cystic fibrosis (CF) patients.

Eligibility Criteria

Inclusion Criteria

  • Confirmed diagnosis of cystic fibrosis
  • Age 12 to 21 years old, of either gender, any race or ethnicity
  • Stable recent pulmonary status (defined as no new pulmonary symptoms, new antibiotic use, or hospitalization for pulmonary symptoms for at least 1 month).
  • We will permit patients treated with the macrolide antibiotic, azithromycin, to participate in this study. Azithromycin has recently become a virtual standard of care in CF, based on small but reproducible improvements in pulmonary function over 4 months of treatment with this drug. The mechanism of benefit is uncertain, but an anti-inflammatory effect has been suggested. The high prevalence of use means that a study without azithromycin would likely require a wash-out period, without data about the appropriate duration for such a wash-out, or whether inflammatory markers would reverse during that time.

Exclusion Criteria

  • Failure to obtain informed consent
  • Positive pregnancy test or lactation
  • Currently enrolled in another study involving radioisotopes or an investigational drug
  • Recent (within 30 days of screening) hospitalization for any reason
  • New antibiotic use (within 30 days of screening).
  • Patient incapable of lying still and supine within the PET/computed X-ray tomography (CT) scanner for 90 minutes.
  • Patient incapable of completing other testing procedures (e.g., PFT, induced sputum)
  • Patient with serum glucose greater than 150 mg/dl at time of PET imaging study
  • Patient incapable of fasting for 4 to 6 hrs prior to PET imaging study
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00846053). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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