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NCT06360627 Clinical Trial

Ultra Low Dose CT and Use of Iomeron 400 in PCD-CT

Lung Cancer Clinical Trial

Official title:
Ultra Low Dose CT and Use of Iomeron 400 in PCD-CT

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06360627
Other study ID # 2022_D0008
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 20, 2023
Est. completion date December 1, 2027

Study information
Verified date April 2024
Source University of Zurich
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Evaluation of ultra low dose protocols and Iomeron 400 contrast in PCD-CT

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date December 1, 2027
Est. primary completion date March 31, 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - CT SCAN for pulmonary nodule detection/follow up - CT SCAN for pneumonia detection/follow up Exclusion Criteria: - under 18 - BMI over 30

Study Design

Related Conditions & MeSH terms

Intervention

Radiation:
• Computed Tomography
Computed Tomography CHEST

Locations
Country Name City State
Switzerland University Hospital Zurich - Diagnostic Radiology Zurich

Sponsors (1)
Lead Sponsor Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Dose Reduction by new scanner mSv per exam will be recorded. This value will be put in correlation to weight (Kg), height (cm) and BMI. through study completion, an average of 1 year
Primary stable Image Quality in reduced dose scans Recorded values compared in 2 populations-different contrast agents by using qualitative&quantitative methods Qualitative:diagnostic certainty, assessability of lung structure/lesions,diagnostic reliability,
Quantitative:Assessment of tissue composition,diagnostic performance measurements Attenuation/sealing measurement (HU), signal-to-noise ratio (SNR), contrast-to-noise ratio ,size dimensions of lung structure/lesion in three dimensions in millimeters Tissue composition assessment diagnostic performance measurements (sensitivity, specificity, accuracy) diagnostic confidence: 1-4
Theses measurements will be put in correlation to the scan dose (mSv) per patient, forming two groups with matched BMI (kg/m^2)		 through study completion, an average of 1 year
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