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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)

Primary Purpose

Multiple Pulmonary Nodules, Pulmonary Emphysema

Status
Unknown status
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Ultralow-Dose-CT
Sponsored by
Cantonal Hospital of St. Gallen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Multiple Pulmonary Nodules

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
January 30, 2015
Last Updated
January 26, 2016
Sponsor
Cantonal Hospital of St. Gallen
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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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