Imaging Airway Liquid Absorption in Cystic Fibrosis
| Status: | Completed |
|---|---|
| Conditions: | Pulmonary |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 6 - Any |
| Updated: | 9/27/2017 |
| Start Date: | October 2011 |
| End Date: | October 2014 |
The investigators are developing a new nuclear medicine imaging technique for measuring
liquid absorption in the airways that can be applied to screen new medications being
developed to treat cystic fibrosis (CF). The investigators believe that the absorption of the
small molecule radiopharmaceutical Indium 111-diethylenetriaminepentaacetic acid (In-DTPA)
will indicate changes in liquid absorption in the airways and demonstrate whether new CF
medications will be effective. In this study the investigators will further develop this
technique through testing involving pediatric CF patients and healthy control subjects.
liquid absorption in the airways that can be applied to screen new medications being
developed to treat cystic fibrosis (CF). The investigators believe that the absorption of the
small molecule radiopharmaceutical Indium 111-diethylenetriaminepentaacetic acid (In-DTPA)
will indicate changes in liquid absorption in the airways and demonstrate whether new CF
medications will be effective. In this study the investigators will further develop this
technique through testing involving pediatric CF patients and healthy control subjects.
The investigators have recently developed a novel aerosol-based imaging technique to detect
changes in liquid absorption in the airways - a central pathophysiological process known to
be important in cystic fibrosis (CF) lung disease. This technique may provide a measure of
disease severity and indication of therapeutic correction in advance of currently available
outcome measures. It involves the simultaneous delivery of two radiopharmaceuticals by
inhalation: one an absorbable small-molecule (Indium-111 labeled
diethylenetriaminepentaacetic acid; In-DTPA) and the other a non-absorbable particle
(Technetium 99m labeled sulfur colloid; Tc-SC). The overarching hypothesis is that In-DTPA
absorption provides a quantifiable, non-invasive measurement of airway liquid absorption that
(a) is sensitive to CF genotype, (b) uniquely identifies basic disease phenotype and predicts
disease severity, and (c) is modulated by therapeutic interventions.
changes in liquid absorption in the airways - a central pathophysiological process known to
be important in cystic fibrosis (CF) lung disease. This technique may provide a measure of
disease severity and indication of therapeutic correction in advance of currently available
outcome measures. It involves the simultaneous delivery of two radiopharmaceuticals by
inhalation: one an absorbable small-molecule (Indium-111 labeled
diethylenetriaminepentaacetic acid; In-DTPA) and the other a non-absorbable particle
(Technetium 99m labeled sulfur colloid; Tc-SC). The overarching hypothesis is that In-DTPA
absorption provides a quantifiable, non-invasive measurement of airway liquid absorption that
(a) is sensitive to CF genotype, (b) uniquely identifies basic disease phenotype and predicts
disease severity, and (c) is modulated by therapeutic interventions.
Inclusion Criteria:
- Adult healthy control arm:
- subjects 18 years old or older without a diagnosis of lung disease.
- Pediatric CF arm:
- subjects 6-14 years with a diagnosis of cystic fibrosis as determined by sweat
test or genotype
- subjects who are clinically stable as determined by the pediatrician
co-investigator
- subjects must have a previously demonstrated ability to perform reproducible
pulmonary function testing based on previous clinical visits.
- Females in all groups who are of child-bearing potential will need to have a negative
urine pregnancy test.
Exclusion Criteria:
- Adult healthy control arm:
- FEV1%p < 80% of predicted
- nursing mother
- positive urine pregnancy test or unwilling to test
- cigarette smoker (regular smoking within 6 months of study).
- Pediatric CF arm:
- FEV1%p < 40% of predicted
- nursing mother
- positive urine pregnancy test for females of childbearing potential
- unable or unwilling to comply with test procedure
- cigarette smoker (regular smoking within 6 months of study).
- Subjects unable to lie recumbent without moving for the 80 minute imaging period
will be excluded.
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