PneumoniaNCT04996693
On Dose Efficiency of Modern CT-scanners in Chest Scans
A study testing Imaging on Scanner with Spectral Imaging Capabilities, CT Scan using an Energy-Integrating Detector CT (128 slice MDCT) and CT Scan using an Energy-Integrating Detector CT (20-slice MDCT) in people with Pneumonia and Lung Cancer, run by University Hospital Augsburg at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia, Lung Cancer, Pulmonary Embolism
- What is being tested?
- Imaging on Scanner with Spectral Imaging Capabilities, CT Scan using an Energy-Integrating Detector CT (128 slice MDCT) and CT Scan using an Energy-Integrating Detector CT (20-slice MDCT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 958 participants
- Where
- 1 siteGermany
- Study dates
- 7 Oct 2021to 31 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: On Dose Efficiency of Modern CT-scanners in Chest Scans- a Prospective, Randomized Study
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.
- Conditions
- Pneumonia, Lung Cancer, Pulmonary Embolism, Pulmonary Disease, Aortic Stenosis
- Being tested
- 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)
- Keywords
- Spectral CT, Computed Tomography, Dose efficiency
- Medical subject headings
- Pneumonia, Lung Neoplasms, Pulmonary Embolism, Lung Diseases, Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imaging on Scanner with Spectral Imaging CapabilitiesDiagnostic test
Also called CT Scan using a Photon-Counting Detector CT: Naeotom Alpha (Siemens Healthineers)
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.
CT Scan using an Energy-Integrating Detector CT (128 slice MDCT)Diagnostic test
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.
CT Scan using an Energy-Integrating Detector CT (20-slice MDCT)Diagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Scanner 1 | Other | Imaging performed on scanner 1: Photon-Counting Detector CT Receives: Diagnostic Test: Imaging on Scanner with Spectral Imaging Capabilities |
| Scanner 2 | Other | Imaging performed on scanner 2: Energy-Integrating Detector CT (128-slice) Receives: Diagnostic Test: CT Scan using an Energy-Integrating Detector CT (128 slice MDCT) |
| Scanner 3 | Other | Imaging performed on scanner 3: Energy-Integrating Detector CT (20-slice) Receives: Diagnostic Test: CT Scan using an Energy-Integrating Detector CT (20-slice MDCT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parameters of Objective Image Quality
Measured as signal, image noise and modulation transfer function equivalent parameters
Measured: 1 year
Parameters of Radiation Dose
measured as x-ray tube parameters such as dose length product (DLP)
Measured: 1 year
Secondary outcomes (1)
Subjective Image Quality Evaluation (entire cohort and for individual disease groups)
measured by blinded evaluation by radiologists
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2021
- Study start7 Oct 2021
- Primary completion31 May 2023
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 958 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Augsburg
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Florian Schwarz, MD, Principal investigator, Universitaetsklinikum Augsburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04996693
- Sponsor's protocol ID
- 21-0368
- Status last verified
- Nov 2023
- First submitted
- 23 Jul 2021
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We plan to share individual participant data upon request (pending final approval by the data protection officer).
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- On Dose Efficiency of Modern CT-scanners in Chest Scans- a Prospective, Randomized Study
- ClinicalTrials.gov ID
- NCT04996693
- Acronym / sponsor ID
- 21-0368
- Conditions
- Pneumonia, Lung Cancer, Pulmonary Embolism, Pulmonary Disease, Aortic Stenosis
- Keywords
- Spectral CT, Computed Tomography, Dose efficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 958 participants (actual)
- Lead sponsor
- University Hospital AugsburgUniversity, hospital or other
- Study start
- 7 Oct 2021 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 9 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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
| Arm | Type | Receives |
|---|---|---|
| Scanner 1 | Other | Diagnostic Test: Imaging on Scanner with Spectral Imaging CapabilitiesImaging performed on scanner 1: Photon-Counting Detector CT |
| Scanner 2 | Other | Diagnostic Test: CT Scan using an Energy-Integrating Detector CT (128 slice MDCT)Imaging performed on scanner 2: Energy-Integrating Detector CT (128-slice) |
| Scanner 3 | Other | Diagnostic Test: CT Scan using an Energy-Integrating Detector CT (20-slice MDCT)Imaging performed on scanner 3: Energy-Integrating Detector CT (20-slice) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Imaging on Scanner with Spectral Imaging CapabilitiesAlso: CT Scan using a Photon-Counting Detector CT: Naeotom Alpha (Siemens Healthineers)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. | Diagnostic test | Scanner 1 |
| CT Scan using an Energy-Integrating Detector CT (128 slice MDCT)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. | Diagnostic test | Scanner 2 |
| CT Scan using an Energy-Integrating Detector CT (20-slice MDCT)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. | Diagnostic test | Scanner 3 |
Primary outcome
Parameters of Objective Image Quality
Time frame: 1 year
Measured as signal, image noise and modulation transfer function equivalent parameters
Parameters of Radiation Dose
Time frame: 1 year
measured as x-ray tube parameters such as dose length product (DLP)
1 secondary outcome
Subjective Image Quality Evaluation (entire cohort and for individual disease groups)
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
- Individual participant dataSharing planned: Yes. We plan to share individual participant data upon request (pending final approval by the data protection officer).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Florian Schwarz, MD principal investigator
Universitaetsklinikum Augsburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Imaging on Scanner with Spectral Imaging Capabilities, CT Scan using an Energy-Integrating Detector CT (128 slice MDCT) and CT Scan using an Energy-Integrating Detector CT (20-slice MDCT) in people with Pneumonia and Lung Cancer, run by University Hospital Augsburg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parameters of Objective Image Quality (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2023; AzTrials last refreshed its copy on 7 Nov 2026.