A Study To Investigate The Ability To Use 18FDG PET Scanning To Monitor The Effectiveness Of New Drugs In COPD Patients
This study has been terminated.
(Study terminated on Nov 7, 2008 as a result of poor recruitment and changes in business priorities. The decision was not based on safety concerns.)
Sponsor:
Pfizer
Collaborator:
Washington University School of Medicine
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00472264
First received: May 9, 2007
Last updated: July 1, 2009
Last verified: July 2009
| Tracking Information | |||||
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| First Received Date ICMJE | May 9, 2007 | ||||
| Last Updated Date | July 1, 2009 | ||||
| Start Date ICMJE | May 2007 | ||||
| Primary Completion Date | October 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Uptake of FDG (Ki) at <1 and 4 weeks [ Time Frame: <1 and 4 weeks ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Uptake of FDG (Ki) at <1 and 4 weeks | ||||
| Change History | Complete list of historical versions of study NCT00472264 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | A Study To Investigate The Ability To Use 18FDG PET Scanning To Monitor The Effectiveness Of New Drugs In COPD Patients | ||||
| Official Title ICMJE | An Exploratory Study To Investigate The Reproducibility Of Lung 18Fluoro-Deoxyglucose Positron Emission Tomography In Patients With Chronic Obstructive Airways Disease (COPD) In The Absence Of Anti-Inflammatory Treatments | ||||
| Brief Summary | It is hypothesised that there is a difference between the uptake of a radioactive substance ([18F]fluorodeoxyglucose (FDG)) in the lungs of patients with Chronic Obstructive Pulmonary Disease (COPD) and healthy volunteers. |
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| Detailed Description | Single site, eligible subjects enrolled in order of presentation. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | 20 Moderate to Severe COPD patients and 8 age- and gender-matched Healthy Volunteer Subjects. |
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| Condition ICMJE | Pulmonary Disease, Chronic Obstructive | ||||
| Intervention ICMJE | Procedure: PET imaging
Medical imaging assessment |
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| Study Group/Cohort (s) | Single arm study (Healthy volunteers & COPD subjects)
A single arm study PET imaging is carried out twice during the first week of the study and again 4 weeks later in both Healthy volunteers and COPD subjects.
Intervention: Procedure: PET imaging |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Terminated | ||||
| Enrollment ICMJE | 20 | ||||
| Completion Date | November 2008 | ||||
| Primary Completion Date | October 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 40 Years to 80 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00472264 | ||||
| Other Study ID Numbers ICMJE | A9011012 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer, Inc. | ||||
| Study Sponsor ICMJE | Pfizer | ||||
| Collaborators ICMJE | Washington University School of Medicine | ||||
| Investigators ICMJE |
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| Information Provided By | Pfizer | ||||
| Verification Date | July 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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