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Diagnostic Value of Ultralow-dose Computed Tomography for the Detection of Pulmonary Nodules and Lung Parenchym Alterations Compared to Standard-dose CT (RADFL)

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ClinicalTrials.gov Identifier: NCT02468609
Recruitment Status : Unknown
Verified January 2016 by Michael Messerli, Cantonal Hospital of St. Gallen.
Recruitment status was:  Recruiting
First Posted : June 11, 2015
Last Update Posted : January 27, 2016
Sponsor:
Information provided by (Responsible Party):
Michael Messerli, Cantonal Hospital of St. Gallen

Brief Summary:
To investigate the diagnostic value of ultralow-dose computed tomography in the detection of pulmonary nodules and lung parenchym alterations (e.g. emphysema) compared to standard-dose-CT.

Condition or disease Intervention/treatment Phase
Multiple Pulmonary Nodules Pulmonary Emphysema Radiation: Ultralow-Dose-CT Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Diagnostic
Study Start Date : January 2015
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Emphysema

Arm Intervention/treatment
Ultralow-Dose-CT
Additional Ultralow-Dose-CT of the chest
Radiation: Ultralow-Dose-CT
Patients undergoing thoracic normal dose-CT with undergo an additional Ultralow-Dose-CT




Primary Outcome Measures :
  1. Number of pulmonary Nodules detected in the Ultralow-Dose thoracic CT [ Time Frame: Participants CT-scan will be read out on an average date of 6 weeks after the scan ]
    Difference in nodule detectability in Ultralow-Dose-CT compared to Standard-Dose-CT measured using McNemar test


Secondary Outcome Measures :
  1. Patients BMI (Body mass index) [ Time Frame: Measures assessed at time of read-out on an average date of 6 weeks after the scan ]
  2. Patients Nodule size (mm) [ Time Frame: Measures assessed at time of read-out on an average date of 6 weeks after the scan ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • planned normal dose-CT by clinical indication at our institution
  • obtained informed consent

Exclusion Criteria:

  • planned lowdose-CT by clinical indication at institution
  • no informed consent obtained
  • age < 18 years
  • pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02468609


Contacts
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Contact: Michael A Messerli, MD 0041 71 494 66 66 Michael.Messerli@kssg.ch

Locations
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Switzerland
Klinik für Radiologie und Nuklearmedizin Recruiting
St. Gallen, Switzerland, 9007
Sponsors and Collaborators
Cantonal Hospital of St. Gallen
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Responsible Party: Michael Messerli, MD, Cantonal Hospital of St. Gallen
ClinicalTrials.gov Identifier: NCT02468609    
Other Study ID Numbers: EKSG 15/007
First Posted: June 11, 2015    Key Record Dates
Last Update Posted: January 27, 2016
Last Verified: January 2016
Additional relevant MeSH terms:
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Multiple Pulmonary Nodules
Pulmonary Emphysema
Emphysema
Pathologic Processes
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms