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

April 9, 2024 updated by: University of Zurich
Evaluation of ultra low dose protocols and Iomeron 400 contrast in PCD-CT

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Zurich, Switzerland, 8091
        • Recruiting
        • University Hospital Zurich - Diagnostic Radiology
        • Contact:
        • Contact:
        • Principal Investigator:
          • Thomas Frauenfelder, PD MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Low Dose
Standard Low Dose CT
Radiation: Computed Tomography
Computed Tomography CHEST
Other: Ultra Low Dose
Ultra Low Dose CT
Radiation: Computed Tomography
Computed Tomography CHEST

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dose Reduction by new scanner
Time Frame: through study completion, an average of 1 year
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
stable Image Quality in reduced dose scans
Time Frame: through study completion, an average of 1 year

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 20, 2023

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

February 27, 2023

First Submitted That Met QC Criteria

April 9, 2024

First Posted (Actual)

April 11, 2024

Study Record Updates

Last Update Posted (Actual)

April 11, 2024

Last Update Submitted That Met QC Criteria

April 9, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022_D0008

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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