Back to resultsOn Dose Efficiency of Modern CT-scanners in Chest Scans
Primary Purpose
Pneumonia, Lung Cancer, Pulmonary Embolism
Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Imaging on Scanner with Spectral Imaging Capabilities
CT Scan using an Energy-Integrating Detector CT (128 slice MDCT)
CT Scan using an Energy-Integrating Detector CT (20-slice MDCT)
Sponsored by
About this trial
This is an interventional diagnostic trial for Pneumonia focused on measuring Spectral CT, Computed Tomography, Dose efficiency
Eligibility Criteria
Inclusion Criteria:
- patient is referred for an unenhanced CT OR contrast-enhanced CT of the chest/thorax confirmed by a board-certified radiologist ('justifying indication' according to German/European radiation protection law) AND
- patient is at least 18 years of age AND
- patient (is able to give informed consent and) has given informed consent.
Exclusion Criteria:
- high degree of medical urgency (i.e. patient cannot be consented for iv contrast according to routine procedures)
- known or suspected pregnancy, or lactating . contraindications for contrast agent (renal failure, allergy, hyperthyroidism)
Sites / Locations
- University Hospital AugsburgRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Other
Other
Arm Label
Scanner 1
Scanner 2
Scanner 3
Arm Description
Imaging performed on scanner 1: Photon-Counting Detector CT
Imaging performed on scanner 2: Energy-Integrating Detector CT (128-slice)
Imaging performed on scanner 3: Energy-Integrating Detector CT (20-slice)
Outcomes
Primary Outcome Measures
Parameters of Objective Image Quality
Measured as signal, image noise and modulation transfer function equivalent parameters
Parameters of Radiation Dose
measured as x-ray tube parameters such as dose length product (DLP)
Secondary Outcome Measures
Subjective Image Quality Evaluation (entire cohort and for individual disease groups)
measured by blinded evaluation by radiologists
Full Information
NCT ID
NCT04996693
First Posted
July 23, 2021
Last Updated
March 7, 2022
Sponsor
University Hospital Augsburg
1. Study Identification
Unique Protocol Identification Number
NCT04996693
Brief Title
On Dose Efficiency of Modern CT-scanners in Chest Scans
Official Title
On Dose Efficiency of Modern CT-scanners in Chest Scans- a Prospective, Randomized Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 7, 2021 (Actual)
Primary Completion Date
October 6, 2023 (Anticipated)
Study Completion Date
October 6, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Augsburg
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
CT scans of the chest / thorax are of great importance both in the initial diagnosis and in the follow-up of pulmonary or thoracic diseases. As an example, CT angiography of the pulmonary arteries (CTPA) is worldwide considered to be gold standard test in patients with a suspicion for pulmonary embolism.
The aim of this study is to measure and compare dose efficiency of modern CT scanners for unenhanced and contrast-enhanced scan protocols of the chest/thorax. Patients who are referred for a CT of the chest/thorax will be randomly assigned to one of the three CT scanners currently in use at our institution.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia, Lung Cancer, Pulmonary Embolism, Pulmonary Disease, Aortic Stenosis
Keywords
Spectral CT, Computed Tomography, Dose efficiency
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomization of patients referred for a CT scan of the thorax on one of three CT scanners routinely used for this purpose in our department
Masking
None (Open Label)
Masking Description
no masking required
Allocation
Randomized
Enrollment
2400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Scanner 1
Arm Type
Other
Arm Description
Imaging performed on scanner 1: Photon-Counting Detector CT
Arm Title
Scanner 2
Arm Type
Other
Arm Description
Imaging performed on scanner 2: Energy-Integrating Detector CT (128-slice)
Arm Title
Scanner 3
Arm Type
Other
Arm Description
Imaging performed on scanner 3: Energy-Integrating Detector CT (20-slice)
Intervention Type
Diagnostic Test
Intervention Name(s)
Imaging on Scanner with Spectral Imaging Capabilities
Other Intervention Name(s)
CT Scan using a Photon-Counting Detector CT: Naeotom Alpha (Siemens Healthineers)
Intervention Description
Patients will undergo imaging on a modern CT scanner with spectral imaging capabilities. A dose neutral spectral acquisition mode will routinely be used. Contrast material protocol and scan ranges are similar in all three arms.
Intervention Type
Diagnostic Test
Intervention Name(s)
CT Scan using an Energy-Integrating Detector CT (128 slice MDCT)
Intervention Description
Patients will undergo imaging on a modern 128-slice CT scanner (Siemens Healthineers) with energy-integrating detector and without spectral acquisition mode. Contrast material protocol and scan ranges are similar in all three arms.
Intervention Type
Diagnostic Test
Intervention Name(s)
CT Scan using an Energy-Integrating Detector CT (20-slice MDCT)
Intervention Description
Patients will undergo imaging on a modern 20-slice CT scanner (Siemens Healthineers) with energy-integrating detector and without spectral acquisition mode. Contrast material protocol and scan ranges are similar in all three arms.
Primary Outcome Measure Information:
Title
Parameters of Objective Image Quality
Description
Measured as signal, image noise and modulation transfer function equivalent parameters
Time Frame
1 year
Title
Parameters of Radiation Dose
Description
measured as x-ray tube parameters such as dose length product (DLP)
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Subjective Image Quality Evaluation (entire cohort and for individual disease groups)
Description
measured by blinded evaluation by radiologists
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patient is referred for an unenhanced CT OR contrast-enhanced CT of the chest/thorax confirmed by a board-certified radiologist ('justifying indication' according to German/European radiation protection law) AND
patient is at least 18 years of age AND
patient (is able to give informed consent and) has given informed consent.
Exclusion Criteria:
high degree of medical urgency (i.e. patient cannot be consented for iv contrast according to routine procedures)
known or suspected pregnancy, or lactating . contraindications for contrast agent (renal failure, allergy, hyperthyroidism)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Florian Schwarz, MD
Phone
+498214002441
Email
radiologie-studien@uk-augsburg.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Florian Schwarz, MD
Organizational Affiliation
Universitaetsklinikum Augsburg
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Augsburg
City
Augsburg
State/Province
Bavaria
ZIP/Postal Code
86156
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Florian Schwarz, MD
Phone
+498214002441
Email
radiologie-studien@uk-augsburg.de
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
We plan to share individual participant data upon request (pending final approval by the data protection officer).
IPD Sharing Time Frame
Requests for sharing individual participant data will be considered at the time of publication of the first manuscript containing result data.
IPD Sharing Access Criteria
We plan to share data on request at this point in time.
Learn more about this trial
On Dose Efficiency of Modern CT-scanners in Chest Scans
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