- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02826265
Evaluation of Novel Lung Function Parameters and Quantitative Computed Tomography (qCT) in Patients With Pulmonary Disease
March 23, 2020 updated by: Dr. Frederik Trinkmann, Universitätsmedizin Mannheim
Current diagnostic tools used in pulmonary disease often do not meet the challenges set by the respective pathophysiology.
The investigators therefore aimed to evaluate novel or not widely used diagnostic approaches for the detection and therapeutic monitoring of patients with various pulmonary diseases.
Study Overview
Status
Unknown
Study Type
Observational
Enrollment (Anticipated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Mannheim, Germany, 68167
- Recruiting
- Universitätsmedizin Mannheim
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Principal Investigator:
- Joachim Saur, Prof. Dr.
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Principal Investigator:
- Thomas Henzler, Prof. Dr.
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Contact:
- Frederik Trinkmann, Dr.
- Phone Number: +49
- Email: frederik.trinkmann@umm.de
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
patients with indication for routine lung function testing and computed tomography
Description
Inclusion Criteria:
- known or suspected pulmonary lung disease
- indication for computed tomography
Exclusion Criteria:
- pregnancy
- inability to participate
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
pulmonary disease
patients with known or suspected pulmonary disease
|
ultra-low-dose qCT
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
correlation of lung clearance index (LCI) as determined by multiple breath washout with emphysema quantification as determined by qCT
Time Frame: 2 weeks
|
2 weeks
|
|
correlation of airway resistance and reactance (R5, X5, R-D5-20) as determined by impulse oscillometry with emphysema quantification as determined by qCT
Time Frame: 2 weeks
|
2 weeks
|
|
correlation of residual volume and airway resistance as determined by body plethysmography with and emphysema quantification as determined by qCT
Time Frame: 2 weeks
|
2 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2016
Primary Completion (Anticipated)
December 1, 2020
Study Completion (Anticipated)
December 1, 2020
Study Registration Dates
First Submitted
June 30, 2016
First Submitted That Met QC Criteria
July 5, 2016
First Posted (Estimate)
July 7, 2016
Study Record Updates
Last Update Posted (Actual)
March 24, 2020
Last Update Submitted That Met QC Criteria
March 23, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MBW-qCT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.