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

Pulmonary Emphysema Clinical Trial

— RADFL  

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02468609
• Other study ID #: EKSG 15/007
• Status: Recruiting
• Phase: N/A
• First received: January 30, 2015
• Last updated: January 26, 2016
• Start date: January 2015
• Est. completion date: December 2016

Study information

• Verified date: January 2016
• Source: Cantonal Hospital of St. Gallen
• Contact: Michael A Messerli, MD
• Phone: 0041 71 494 66 66
• Email: Michael.Messerli[@]kssg.ch
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Emphysema
• Multiple Pulmonary Nodules
• Pulmonary Emphysema

Intervention

Radiation:
• Ultralow-Dose-CT
Patients undergoing thoracic normal dose-CT with undergo an additional Ultralow-Dose-CT

Locations

Country	Name	City	State
Switzerland	Klinik für Radiologie und Nuklearmedizin	St. Gallen

Sponsors (1)

Lead Sponsor	Collaborator
Cantonal Hospital of St. Gallen

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Participants CT-scan will be read out on an average date of 6 weeks after the scan	No
Secondary	Patients BMI (Body mass index)		Measures assessed at time of read-out on an average date of 6 weeks after the scan	No
Secondary	Patients Nodule size (mm)		Measures assessed at time of read-out on an average date of 6 weeks after the scan	No