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

• Sponsor: Cantonal Hospital of St. Gallen (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02468609
• Collaborator: (none)
• Enrollment: 500
• Location: 1
• Arm: 1
• Duration (Months): 23
• Patients Per Site Per Month: 21.7

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Pulmonary Nodules; Pulmonary Emphysema	Radiation: Ultralow-Dose-CT	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 500 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: Single (Investigator)
• Primary Purpose: Diagnostic
• Study Start Date: Jan 1, 2015
• Anticipated Primary Completion Date: Dec 1, 2016
• Anticipated Study Completion Date: Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Other: 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

Outcome Measures

Primary Outcome Measures

1. Number of pulmonary Nodules detected in the Ultralow-Dose thoracic CT [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) [Measures assessed at time of read-out on an average date of 6 weeks after the scan]

2. Patients Nodule size (mm) [Measures assessed at time of read-out on an average date of 6 weeks after the scan]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Klinik für Radiologie und Nuklearmedizin	St. Gallen		Switzerland	9007

Sponsors and Collaborators

• Cantonal Hospital of St. Gallen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Michael Messerli, MD, Cantonal Hospital of St. Gallen
• ClinicalTrials.gov Identifier: NCT02468609
• Other Study ID Numbers: EKSG 15/007
• First Posted: Jun 11, 2015
• Last Update Posted: Jan 27, 2016
• Last Verified: Jan 1, 2016

• Additional relevant MeSH terms: Multiple Pulmonary Nodules; Pulmonary Emphysema; Emphysema

Study Results

No Results Posted as of Jan 27, 2016