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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT00684346 |
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Date of registration:
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08/05/2008 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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18FDG-PET Imaging to Detect Changes in Airways Inflammation in Cystic Fibrosis Patients
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Scientific title:
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A Pilot Study of 18FDG-PET Imaging to Detect Changes in Airways Inflammation in Cystic Fibrosis Patients After Treatment for a Pulmonary Exacerbation |
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Date of first enrolment:
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April 2008 |
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Target sample size:
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20 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00684346 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
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Phase:
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Phase 3
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Countries of recruitment
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Canada
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Contacts
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Name:
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Felix Ratjen, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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The Hospital for Sick Children |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Diagnosis of CF as defined by two or more clinical features of CF and a documented
sweat chloride > 60mEq/L by quantitative pilocarpine iontophoresis test or a genotype
showing two well characterized disease causing mutations
- Informed consent and verbal assent (as appropriate) provided by the subject's parent
or legal guardian and the subject
- Ages 6-18 and able to perform reproducible spirometry
- Admission to the Hospital for Sick Children for a pulmonary exacerbation
Exclusion Criteria:
- Inability to perform reproducible spirometry
- Diagnosis of Cystic Fibrosis Related Diabetes (CFRD)
- Medical instability that would preclude the ability to perform PET imaging
- FEV1% predicted < 40%
- The use of supplementary oxygen
- Pregnancy or breastfeeding
- Severe claustrophobia
Age minimum:
6 Years
Age maximum:
18 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Cystic Fibrosis
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Intervention(s)
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Other: 18-FDG
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Primary Outcome(s)
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Change in airways inflammation detected by 18FDG -PET from baseline
[Time Frame: Measured at end of treatment (day 14)]
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Secondary Outcome(s)
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Correlation of pre and post 18FDG-PET data with lung function (FEV1, FEF 25-75 and FVC), sputum neutrophil count and sputum free elastase
[Time Frame: Measured at end of treatment (day 14)]
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Secondary ID(s)
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1000011762
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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