Diagnostic Value of Ultralow-dose Computed Tomography for the Detection of Pulmonary Nodules and Lung Parenchym Alterations Compared to Standard-dose CT (RADFL)
Primary Purpose
Multiple Pulmonary Nodules, Pulmonary Emphysema
Status
Unknown status
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Ultralow-Dose-CT
Sponsored by
About this trial
This is an interventional diagnostic trial for Multiple Pulmonary Nodules
Eligibility 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
Sites / Locations
- Klinik für Radiologie und NuklearmedizinRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Ultralow-Dose-CT
Arm Description
Additional Ultralow-Dose-CT of the chest
Outcomes
Primary Outcome Measures
Number of pulmonary Nodules detected in the Ultralow-Dose thoracic CT
Difference in nodule detectability in Ultralow-Dose-CT compared to Standard-Dose-CT measured using McNemar test
Secondary Outcome Measures
Patients BMI (Body mass index)
Patients Nodule size (mm)
Full Information
NCT ID
NCT02468609
First Posted
January 30, 2015
Last Updated
January 26, 2016
Sponsor
Cantonal Hospital of St. Gallen
1. Study Identification
Unique Protocol Identification Number
NCT02468609
Brief Title
Diagnostic Value of Ultralow-dose Computed Tomography for the Detection of Pulmonary Nodules and Lung Parenchym Alterations Compared to Standard-dose CT
Acronym
RADFL
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cantonal Hospital of St. Gallen
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Pulmonary Nodules, Pulmonary Emphysema
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
N/A
Enrollment
500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ultralow-Dose-CT
Arm Type
Other
Arm Description
Additional Ultralow-Dose-CT of the chest
Intervention Type
Radiation
Intervention Name(s)
Ultralow-Dose-CT
Intervention Description
Patients undergoing thoracic normal dose-CT with undergo an additional Ultralow-Dose-CT
Primary Outcome Measure Information:
Title
Number of pulmonary Nodules detected in the Ultralow-Dose thoracic CT
Description
Difference in nodule detectability in Ultralow-Dose-CT compared to Standard-Dose-CT measured using McNemar test
Time Frame
Participants CT-scan will be read out on an average date of 6 weeks after the scan
Secondary Outcome Measure Information:
Title
Patients BMI (Body mass index)
Time Frame
Measures assessed at time of read-out on an average date of 6 weeks after the scan
Title
Patients Nodule size (mm)
Time Frame
Measures assessed at time of read-out on an average date of 6 weeks after the scan
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael A Messerli, MD
Phone
0041 71 494 66 66
Email
Michael.Messerli@kssg.ch
Facility Information:
Facility Name
Klinik für Radiologie und Nuklearmedizin
City
St. Gallen
ZIP/Postal Code
9007
Country
Switzerland
Individual Site Status
Recruiting
12. IPD Sharing Statement
Learn more about this trial
Diagnostic Value of Ultralow-dose Computed Tomography for the Detection of Pulmonary Nodules and Lung Parenchym Alterations Compared to Standard-dose CT
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