Chest PainUP-ChestNCT03922516
Accuracy of Ultra-Low-Dose-CT of the Chest Compared to Plain Film in an Unfiltered Emergency Department Patient Cohort
A study testing ULDCT in people with Chest Pain and Cough, run by Medical University of Vienna at 1 site in Austria.
Trial summary
This trial compares the accuracy provided by plain film as well as ultra-low-dose-computed-tomography (ULDCT) of the chest. It also aims to analyze differences in diagnostic confidence and therapeutic consequence offered by these two imaging modalities. Read more about this study
- Who is it for?
- Ages 18 to 92 years
- Conditions the study is for
- Chest Pain, Cough, Thoracic Diseases
- What is being tested?
- ULDCT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 295 participants
- Where
- 1 siteAustria
- Study dates
- 2 May 2019to 26 Nov 2019
- 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 to 92 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- all patients who are assigned to a clinically indicated chest X-ray by the emergency department of Vienna General Hospital
- ability to provide informed consent
- informed consent after detailed patient briefing
Who cannot join
- the emergency departments assessment of a critical clinical condition oppose an examination with both modalities (ULDCT of the chest, chest X-ray)
- assigned to chest X-ray as follow-up
- women with positive ß-HCG-test
Trial locations and contacts
1 site in 1 country.
Austria1 site
Vienna General Hospital - Medical University of Vienna
Vienna, 1090
About this study
Official title: Accuracy of Ultra-Low-Dose-CT (ULDCT) of the Chest Compared to Plain Film in an Unfiltered Emergency Department Patient Cohort
This trial compares the accuracy provided by plain film as well as ultra-low-dose-computed-tomography (ULDCT) of the chest. It also aims to analyze differences in diagnostic confidence and therapeutic consequence offered by these two imaging modalities.
Read the detailed description
For nearly a century, chest X-ray (plain film, projectional radiography) has been the established primary imaging modality for patients with acute chest pain, suspected pneumonia, and / or acute dyspnoea in the diagnostic pathway of emergency departments, although the sensitivity and specificity of this X-ray technique are moderate.
The widespread availability and use of chest X-ray is due to the low acquisition and operating costs for projectional radiography equipment, the short examination time, and the very low radiation exposure. In addition, projectional radiography of the chest often serves as a guide for further, more sensitive, diagnostical procedures. However, these advantages are partially offset by the disadvantages inherent to projectional methods: anatomical structures may superpose or mask pathological structures. As a result, some areas of the lung may be obscured, and assessment may therefore be limited.
Whereas computed tomography was reserved for certain clinical questions over the last few decades, and, in most cases, served as a second imaging approach after plain film radiography, it has increasingly evolved as a primary imaging modality for several indications (e.g., suspicion of pulmonary embolism, highly suspected aortic dissection). This rise of computed tomography was due not only to its significant advantage of no superposition, but also partly driven by the marked reduction in radiation dose needed without sacrificing image quality. This was driven by the development of new detectors, modulation of tube current and voltage, as well as iterative reconstruction techniques. As a result, recent computed tomography scanners currently offer not only a more precise visualization of differences in tissue-attenuation and the significant advantage of the absence of artefacts due to superposition, but also allow for imaging with a considerably reduced radiation dosage compared to older scanners. Therefore, computed tomography may now be utilized as screening method in specific indications that carry an increased risk of certain pathologies (e.g., in long-time smokers). The introduction of the latest generation of computed tomography devices about three years ago allowed for an even further reduction in dose by filtering out low-energy photons using a tin filter, which offers the possibility of a reduction in radiation dose by another 50 % or more for established CT indications. For specific indications (e.g., lung nodules in follow-up), the radiation dose may even be reduced to a tenth or one-hundredth of a standard-dose CT (SDCT).
The current reference dose-length-product (DLP) in Germany for thoracic standard-dose CT (SDCT) is ~350 mGycm (effective dose ~6 mSv) and, for thoracic low-dose-CT (LDCT / HR-CT), ~100 mGycm (effective dose ~1.7 mSv). However, the latest devices (third-generation dual-energy CT) provide the opportunity to considerably reduce the reference dose of thoracic low-dose CT. In the current literature, these scans are referred to as Ultra-Low-Dose-CT (ULDCT) and are usually associated with a radiation dosage of 0.14 to 0.5 mSv. For this dose range, no standardized reference values have been published as yet.
The limiting factors of ULDCT are quantum noise, loss of spatial resolution, and other image artefacts. Therefore, careful selection of appropriate CT protocols and dosage is mandatory in order to achieve sufficient image quality to answer the respective diagnostic question.
Several papers have been published on the subject of ULDCT, which are dedicated to the comparison of ULDCT with LDCT and/or SDCT. These papers conclude that this technology may be used with sufficient sensitivity and specificity for indications such as dyspnea, emphysema, or lung nodules. Due to the potential to reduce the radiation dose to less than 1/30 of a standard-dose CT while still providing acceptable image quality with the latest generation of devices, ULDCT of the chest is emerging as an interesting alternative to conventional chest X-ray.
To the best of the authors' knowledge, there are currently no studies comparing and evaluating ultra-low-dose-CT as a primary imaging alternative to chest X-ray in emergency department patients.
This study aims to compare ULDCT and plain film of the chest with regard to their accuracy in an unfiltered patient cohort of an emergency department. For this purpose, the investigator's ULDCT protocol will use the lowest possible dose at which image quality is diagnostically sufficient (approximately 0.2 mSv effective dose). This corresponds to less than 1/30 of the radiation dose of a standard-dose CT of the chest and to only about 2.5 times the dose of a chest X-ray in two views. This dose is equal to less than a month of natural background radiation in Austria and less than the radiation exposure on an intercontinental flight.
In addition to the accuracy of ULDCT of the chest compared to plain film of the chest, this trial also aims to analyze the clinical relevance of both methods by assessing the respective impact on final diagnosis, as well as possible changes in therapy.
- Conditions
- Chest Pain, Cough, Thoracic Diseases, Lung Diseases
- Being tested
- ULDCT
- Medical subject headings
- Chest Pain, Cough, Thoracic Diseases, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ULDCTDiagnostic test
Ultra-Low-Dose-CT (ULDCT) of the chest using tin filters with third-generation dual-energy CT devices. The projected dose used will be approximately 0.2 mSv per ULDCT of the chest.
| Study group | Role | What they receive |
|---|---|---|
| Reporting order: Plain Film - ULDCT | Other | The plain film of half the participants (randomized) will be submitted for reporting by a radiologist as a first imaging method. After finishing this report, the same radiologist will assess the ULDCT of this participant. In this second report, the findings of both examinations will be summarized, and a second report will be filed.
Emergency physicians will first receive the report for the plain film of the chest and will be asked for the diagnosis and its probability. Next, the report for ULDCT will be presented to them. Again, diagnosis and probabilities will be documented. Receives: Diagnostic Test: ULDCT |
| Reporting order: ULDCT - Plain Film | Other | For half the participants (randomized) radiologists will first receive the data from ULDCT of the chest and write a report. Subsequently, they will receive the data from the plain film of the chest and may expand their report (explicitly separated).
Emergency physicians will first receive the report for the ULDCT of the chest and will be asked for probabilities of the nine most frequent diagnoses in chest-imaging plus "other". Next, they will be presented with the report for the plain film and will again be asked to give an estimation of the probabilities for the same diagnoses as before. Receives: Diagnostic Test: ULDCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of ultra-low-dose-CT of the chest and plain film of the chest
Initial radiologic diagnostic accuracy of both methods will be assessed by analyzing the number of reports that are changed after the images of the second modality become available to the radiologist in Arm 1 compared to Arm 2.
In a final approach, the diagnostic accuracy will be analyzed by retrospectively comparing all reports with the gold standard, which will be built from all available patient data at the end of the study, including all follow-up imaging studies and laboratory tests.
Measured: 1 year
Secondary outcomes (9)
Sensitivity and Specificity of ULDCT and plain film
Comparison between the two arms "ULDCT - Plain Film" and "Plain Film - ULDCT"
Measured: 1 year
Frequency of change in radiological diagnosis
Comparison between the two arms "ULDCT - Plain Film" and "Plain Film - ULDCT"
Measured: 1 year
Frequency of change in emergency physician's diagnosis
Comparison between the two arms "ULDCT - Plain Film" and "Plain Film - ULDCT"
Measured: 1 year
Frequency of change in (planned) therapeutic course of action by emergency physician
Comparison between the two arms "ULDCT - Plain Film" and "Plain Film - ULDCT"
Measured: 1 year
Frequency of accidental diagnosis in ULDCT and plain film
Comparison between the two arms "ULDCT - Plain Film" and "Plain Film - ULDCT"
Measured: 1 year
Frequency of additional diagnostic imaging needed
Comparison between the two arms "ULDCT - Plain Film" and "Plain Film - ULDCT"
Measured: 1 year
Frequency of unclear reports in ULDCT and plain film
Comparison between the two arms "ULDCT - Plain Film" and "Plain Film - ULDCT"
Measured: 1 year
Diagnostic confidence in ULDCT and plain film by radiologist
Comparison between the two arms "ULDCT - Plain Film" and "Plain Film - ULDCT"
Measured: 1 year
Diagnostic confidence in ULDCT and plain film by emergency physician
Comparison between the two arms "ULDCT - Plain Film" and "Plain Film - ULDCT"
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 posted22 Apr 2019
- Study start2 May 2019
- Primary completion26 Nov 2019
- Study completion26 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (35)Papers the sponsor has linked to this study.
- Other trials for Chest PainStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 295 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Collaborators
- Siemens AG
- Responsible party
- Principal investigator, Prof Helmut Ringl, MD, Medical University of Vienna
- Investigators
- Helmut Ringl, MD, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03922516
- Sponsor's protocol ID
- EK-Nr. 2254/2018
- Acronym
- UP-Chest
- Status last verified
- Dec 2019
- First submitted
- 17 Apr 2019
- Last updated
- 19 Dec 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
van der Aalst CM, Ten Haaf K, de Koning HJ. Lung cancer screening: latest developments and unanswered questions. Lancet Respir Med. 2016 Sep;4(9):749-761. doi: 10.1016/S2213-2600(16)30200-4.
PubMed 27599248Andronikou S, Lambert E, Halton J, Hilder L, Crumley I, Lyttle MD, Kosack C. Guidelines for the use of chest radiographs in community-acquired pneumonia in children and adolescents. Pediatr Radiol. 2017 Oct;47(11):1405-1411. doi: 10.1007/s00247-017-3944-4. Epub 2017 Sep 21.
PubMed 29043422Radiation Emissions from Computed Tomography: A Review of the Risk of Cancer and Guidelines [Internet]. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2014 Jun 4. Available from http://www.ncbi.nlm.nih.gov/books/NBK263458/
PubMed 25535640Berrington de Gonzalez A, Mahesh M, Kim KP, Bhargavan M, Lewis R, Mettler F, Land C. Projected cancer risks from computed tomographic scans performed in the United States in 2007. Arch Intern Med. 2009 Dec 14;169(22):2071-7. doi: 10.1001/archinternmed.2009.440.
PubMed 20008689Braun FM, Johnson TR, Sommer WH, Thierfelder KM, Meinel FG. Chest CT using spectral filtration: radiation dose, image quality, and spectrum of clinical utility. Eur Radiol. 2015 Jun;25(6):1598-606. doi: 10.1007/s00330-014-3559-1. Epub 2014 Dec 17.
PubMed 25515204Brenner DJ, Hall EJ. Computed tomography--an increasing source of radiation exposure. N Engl J Med. 2007 Nov 29;357(22):2277-84. doi: 10.1056/NEJMra072149. No abstract available.
PubMed 18046031Cardinale L, Priola AM, Moretti F, Volpicelli G. Effectiveness of chest radiography, lung ultrasound and thoracic computed tomography in the diagnosis of congestive heart failure. World J Radiol. 2014 Jun 28;6(6):230-7. doi: 10.4329/wjr.v6.i6.230.
PubMed 24976926Chalmers JD. The Modern Diagnostic Approach to Community-Acquired Pneumonia in Adults. Semin Respir Crit Care Med. 2016 Dec;37(6):876-885. doi: 10.1055/s-0036-1592125. Epub 2016 Dec 13.
PubMed 27960211Chawla A, Rajendran S, Yung WH, Babu SB, Peh WC. Chest radiography in acute aortic syndrome: pearls and pitfalls. Emerg Radiol. 2016 Aug;23(4):405-12. doi: 10.1007/s10140-016-1415-0. Epub 2016 Jun 9.
PubMed 27282377Fintelmann FJ, Gottumukkala RV, McDermott S, Gilman MD, Lennes IT, Shepard JO. Lung Cancer Screening: Why, When, and How? Radiol Clin North Am. 2017 Nov;55(6):1163-1181. doi: 10.1016/j.rcl.2017.06.003.
PubMed 28991558Haubenreisser H, Meyer M, Sudarski S, Allmendinger T, Schoenberg SO, Henzler T. Unenhanced third-generation dual-source chest CT using a tin filter for spectral shaping at 100kVp. Eur J Radiol. 2015 Aug;84(8):1608-1613. doi: 10.1016/j.ejrad.2015.04.018. Epub 2015 Apr 28.
PubMed 26001437Horeweg N, Scholten ET, de Jong PA, van der Aalst CM, Weenink C, Lammers JW, Nackaerts K, Vliegenthart R, ten Haaf K, Yousaf-Khan UA, Heuvelmans MA, Thunnissen E, Oudkerk M, Mali W, de Koning HJ. Detection of lung cancer through low-dose CT screening (NELSON): a prespecified analysis of screening test performance and interval cancers. Lancet Oncol. 2014 Nov;15(12):1342-50. doi: 10.1016/S1470-2045(14)70387-0. Epub 2014 Oct 1.
PubMed 25282284Kim Y, Kim YK, Lee BE, Lee SJ, Ryu YJ, Lee JH, Chang JH. Ultra-Low-Dose CT of the Thorax Using Iterative Reconstruction: Evaluation of Image Quality and Radiation Dose Reduction. AJR Am J Roentgenol. 2015 Jun;204(6):1197-202. doi: 10.2214/AJR.14.13629.
PubMed 26001228Kubo T, Ohno Y, Kauczor HU, Hatabu H. Radiation dose reduction in chest CT--review of available options. Eur J Radiol. 2014 Oct;83(10):1953-61. doi: 10.1016/j.ejrad.2014.06.033. Epub 2014 Jul 9.
PubMed 25066756Kubo T, Ohno Y, Seo JB, Yamashiro T, Kalender WA, Lee CH, Lynch DA, Kauczor HU, Hatabu H. Securing safe and informative thoracic CT examinations-Progress of radiation dose reduction techniques. Eur J Radiol. 2017 Jan;86:313-319. doi: 10.1016/j.ejrad.2016.10.012. Epub 2016 Oct 13.
PubMed 27773483
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Ultra-Low-Dose-CT (ULDCT) of the Chest Compared to Plain Film in an Unfiltered Emergency Department Patient Cohort
- ClinicalTrials.gov ID
- NCT03922516
- Acronym / sponsor ID
- UP-Chest / EK-Nr. 2254/2018
- Conditions
- Chest Pain, Cough, Thoracic Diseases, Lung Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 295 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Collaborators
- Siemens AG
- Study start
- 2 May 2019 (actual)
- Primary completion
- 26 Nov 2019 (actual)
- Study completion
- 26 Nov 2019 (actual)
- First posted
- 22 Apr 2019 (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.
This trial compares the accuracy provided by plain film as well as ultra-low-dose-computed-tomography (ULDCT) of the chest. It also aims to analyze differences in diagnostic confidence and therapeutic consequence offered by these two imaging modalities.
Detailed description
For nearly a century, chest X-ray (plain film, projectional radiography) has been the established primary imaging modality for patients with acute chest pain, suspected pneumonia, and / or acute dyspnoea in the diagnostic pathway of emergency departments, although the sensitivity and specificity of this X-ray technique are moderate.
The widespread availability and use of chest X-ray is due to the low acquisition and operating costs for projectional radiography equipment, the short examination time, and the very low radiation exposure. In addition, projectional radiography of the chest often serves as a guide for further, more sensitive, diagnostical procedures. However, these advantages are partially offset by the disadvantages inherent to projectional methods: anatomical structures may superpose or mask pathological structures. As a result, some areas of the lung may be obscured, and assessment may therefore be limited.
Whereas computed tomography was reserved for certain clinical questions over the last few decades, and, in most cases, served as a second imaging approach after plain film radiography, it has increasingly evolved as a primary imaging modality for several indications (e.g., suspicion of pulmonary embolism, highly suspected aortic dissection). This rise of computed tomography was due not only to its significant advantage of no superposition, but also partly driven by the marked reduction in radiation dose needed without sacrificing image quality. This was driven by the development of new detectors, modulation of tube current and voltage, as well as iterative reconstruction techniques. As a result, recent computed tomography scanners currently offer not only a more precise visualization of differences in tissue-attenuation and the significant advantage of the absence of artefacts due to superposition, but also allow for imaging with a considerably reduced radiation dosage compared to older scanners. Therefore, computed tomography may now be utilized as screening method in specific indications that carry an increased risk of certain pathologies (e.g., in long-time smokers). The introduction of the latest generation of computed tomography devices about three years ago allowed for an even further reduction in dose by filtering out low-energy photons using a tin filter, which offers the possibility of a reduction in radiation dose by another 50 % or more for established CT indications. For specific indications (e.g., lung nodules in follow-up), the radiation dose may even be reduced to a tenth or one-hundredth of a standard-dose CT (SDCT).
The current reference dose-length-product (DLP) in Germany for thoracic standard-dose CT (SDCT) is ~350 mGycm (effective dose ~6 mSv) and, for thoracic low-dose-CT (LDCT / HR-CT), ~100 mGycm (effective dose ~1.7 mSv). However, the latest devices (third-generation dual-energy CT) provide the opportunity to considerably reduce the reference dose of thoracic low-dose CT. In the current literature, these scans are referred to as Ultra-Low-Dose-CT (ULDCT) and are usually associated with a radiation dosage of 0.14 to 0.5 mSv. For this dose range, no standardized reference values have been published as yet.
The limiting factors of ULDCT are quantum noise, loss of spatial resolution, and other image artefacts. Therefore, careful selection of appropriate CT protocols and dosage is mandatory in order to achieve sufficient image quality to answer the respective diagnostic question.
Several papers have been published on the subject of ULDCT, which are dedicated to the comparison of ULDCT with LDCT and/or SDCT. These papers conclude that this technology may be used with sufficient sensitivity and specificity for indications such as dyspnea, emphysema, or lung nodules. Due to the potential to reduce the radiation dose to less than 1/30 of a standard-dose CT while still providing acceptable image quality with the latest generation of devices, ULDCT of the chest is emerging as an interesting alternative to conventional chest X-ray.
To the best of the authors' knowledge, there are currently no studies comparing and evaluating ultra-low-dose-CT as a primary imaging alternative to chest X-ray in emergency department patients.
This study aims to compare ULDCT and plain film of the chest with regard to their accuracy in an unfiltered patient cohort of an emergency department. For this purpose, the investigator's ULDCT protocol will use the lowest possible dose at which image quality is diagnostically sufficient (approximately 0.2 mSv effective dose). This corresponds to less than 1/30 of the radiation dose of a standard-dose CT of the chest and to only about 2.5 times the dose of a chest X-ray in two views. This dose is equal to less than a month of natural background radiation in Austria and less than the radiation exposure on an intercontinental flight.
In addition to the accuracy of ULDCT of the chest compared to plain film of the chest, this trial also aims to analyze the clinical relevance of both methods by assessing the respective impact on final diagnosis, as well as possible changes in therapy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reporting order: Plain Film - ULDCT | Other | Diagnostic Test: ULDCTThe plain film of half the participants (randomized) will be submitted for reporting by a radiologist as a first imaging method. After finishing this report, the same radiologist will assess the ULDCT of this participant. In this second report, the findings of both examinations will be summarized, and a second report will be filed. Emergency physicians will first receive the report for the plain film of the chest and will be asked for the diagnosis and its probability. Next, the report for ULDCT will be presented to them. Again, diagnosis and probabilities will be documented. |
| Reporting order: ULDCT - Plain Film | Other | Diagnostic Test: ULDCTFor half the participants (randomized) radiologists will first receive the data from ULDCT of the chest and write a report. Subsequently, they will receive the data from the plain film of the chest and may expand their report (explicitly separated). Emergency physicians will first receive the report for the ULDCT of the chest and will be asked for probabilities of the nine most frequent diagnoses in chest-imaging plus "other". Next, they will be presented with the report for the plain film and will again be asked to give an estimation of the probabilities for the same diagnoses as before. |
Who may qualify
- Ages
- 18 to 92 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- all patients who are assigned to a clinically indicated chest X-ray by the emergency department of Vienna General Hospital
- ability to provide informed consent
- informed consent after detailed patient briefing
Key exclusion criteria (3 listed)
- the emergency departments assessment of a critical clinical condition oppose an examination with both modalities (ULDCT of the chest, chest X-ray)
- assigned to chest X-ray as follow-up
- women with positive ß-HCG-test
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 |
|---|---|---|
| ULDCTUltra-Low-Dose-CT (ULDCT) of the chest using tin filters with third-generation dual-energy CT devices. The projected dose used will be approximately 0.2 mSv per ULDCT of the chest. | Diagnostic test | Reporting order: Plain Film - ULDCT, Reporting order: ULDCT - Plain Film |
Primary outcome
Accuracy of ultra-low-dose-CT of the chest and plain film of the chest
Time frame: 1 year
Initial radiologic diagnostic accuracy of both methods will be assessed by analyzing the number of reports that are changed after the images of the second modality become available to the radiologist in Arm 1 compared to Arm 2. In a final approach, the diagnostic accuracy will be analyzed by retrospectively comparing all reports with the gold standard, which will be built from all available patient data at the end of the study, including all follow-up imaging studies and laboratory tests.
9 secondary outcomes
Sensitivity and Specificity of ULDCT and plain film
Time frame: 1 year
Frequency of change in radiological diagnosis
Time frame: 1 year
Frequency of change in emergency physician's diagnosis
Time frame: 1 year
Frequency of change in (planned) therapeutic course of action by emergency physician
Time frame: 1 year
Frequency of accidental diagnosis in ULDCT and plain film
Time frame: 1 year
Frequency of additional diagnostic imaging needed
Time frame: 1 year
Frequency of unclear reports in ULDCT and plain film
Time frame: 1 year
Diagnostic confidence in ULDCT and plain film by radiologist
Time frame: 1 year
Diagnostic confidence in ULDCT and plain film by emergency physician
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 19 Dec 2019.
- Background: PubMed 27599248van der Aalst CM, Ten Haaf K, de Koning HJ. Lung cancer screening: latest developments and unanswered questions. Lancet Respir Med. 2016 Sep;4(9):749-761. doi: 10.1016/S2213-2600(16)30200-4.
- Background: PubMed 29043422Andronikou S, Lambert E, Halton J, Hilder L, Crumley I, Lyttle MD, Kosack C. Guidelines for the use of chest radiographs in community-acquired pneumonia in children and adolescents. Pediatr Radiol. 2017 Oct;47(11):1405-1411. doi: 10.1007/s00247-017-3944-4. Epub 2017 Sep 21.
- Background: PubMed 25535640Radiation Emissions from Computed Tomography: A Review of the Risk of Cancer and Guidelines [Internet]. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2014 Jun 4. Available from http://www.ncbi.nlm.nih.gov/books/NBK263458/
- Background: PubMed 20008689Berrington de Gonzalez A, Mahesh M, Kim KP, Bhargavan M, Lewis R, Mettler F, Land C. Projected cancer risks from computed tomographic scans performed in the United States in 2007. Arch Intern Med. 2009 Dec 14;169(22):2071-7. doi: 10.1001/archinternmed.2009.440.
- Background: PubMed 25515204Braun FM, Johnson TR, Sommer WH, Thierfelder KM, Meinel FG. Chest CT using spectral filtration: radiation dose, image quality, and spectrum of clinical utility. Eur Radiol. 2015 Jun;25(6):1598-606. doi: 10.1007/s00330-014-3559-1. Epub 2014 Dec 17.
- Background: PubMed 18046031Brenner DJ, Hall EJ. Computed tomography--an increasing source of radiation exposure. N Engl J Med. 2007 Nov 29;357(22):2277-84. doi: 10.1056/NEJMra072149. No abstract available.
- Background: PubMed 24976926Cardinale L, Priola AM, Moretti F, Volpicelli G. Effectiveness of chest radiography, lung ultrasound and thoracic computed tomography in the diagnosis of congestive heart failure. World J Radiol. 2014 Jun 28;6(6):230-7. doi: 10.4329/wjr.v6.i6.230.
- Background: PubMed 27960211Chalmers JD. The Modern Diagnostic Approach to Community-Acquired Pneumonia in Adults. Semin Respir Crit Care Med. 2016 Dec;37(6):876-885. doi: 10.1055/s-0036-1592125. Epub 2016 Dec 13.
- Background: PubMed 27282377Chawla A, Rajendran S, Yung WH, Babu SB, Peh WC. Chest radiography in acute aortic syndrome: pearls and pitfalls. Emerg Radiol. 2016 Aug;23(4):405-12. doi: 10.1007/s10140-016-1415-0. Epub 2016 Jun 9.
- Background: PubMed 28991558Fintelmann FJ, Gottumukkala RV, McDermott S, Gilman MD, Lennes IT, Shepard JO. Lung Cancer Screening: Why, When, and How? Radiol Clin North Am. 2017 Nov;55(6):1163-1181. doi: 10.1016/j.rcl.2017.06.003.
- Background: PubMed 26001437Haubenreisser H, Meyer M, Sudarski S, Allmendinger T, Schoenberg SO, Henzler T. Unenhanced third-generation dual-source chest CT using a tin filter for spectral shaping at 100kVp. Eur J Radiol. 2015 Aug;84(8):1608-1613. doi: 10.1016/j.ejrad.2015.04.018. Epub 2015 Apr 28.
- Background: PubMed 25282284Horeweg N, Scholten ET, de Jong PA, van der Aalst CM, Weenink C, Lammers JW, Nackaerts K, Vliegenthart R, ten Haaf K, Yousaf-Khan UA, Heuvelmans MA, Thunnissen E, Oudkerk M, Mali W, de Koning HJ. Detection of lung cancer through low-dose CT screening (NELSON): a prespecified analysis of screening test performance and interval cancers. Lancet Oncol. 2014 Nov;15(12):1342-50. doi: 10.1016/S1470-2045(14)70387-0. Epub 2014 Oct 1.
- Austrian Federal Ministry of Labour, Social Affairs, Health and Consumer Protection 2018a. Radiation Application in Medicine \| Health Portal \[Online\]. \[Accessed: 22 November 2018\].Link provided by the sponsor.
- Austrian Federal Ministry of Labour, Social Affairs, Health and Consumer Protection 2018b. Radiation Exposure in Austria \| Health Portal \[Online\]. \[Accessed: 22 NovemberLink provided by the sponsor.
- German Federal Office for Radiation Protection. Diagnostic Reference Levels. June 2016Link provided by the sponsor.
- Gesundheit Österreich GmbH (Health Austria GmbH). Update on diagnostic reference values for Austria 2017Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Lung Cancer and Aging: Improving Well-being for Older Adults With Lung Cancer
Lung Cancer
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CT Stress Myocardial Perfusion, Fractional Flow Reserve and Angiography in Patients With Stable Chest Pain Syndromes
Coronary Artery Disease, Chest Syndrome
RecruitingPhase 4
Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
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Recruiting
AI-Assisted Interpretation of Cardiac CT in the Emergency Department
Chest Pain, Acute Coronary Syndrome
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.
Helmut Ringl, MD principal investigator
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ULDCT in people with Chest Pain and Cough, run by Medical University of Vienna at 1 site in Austria.
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 3 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 19 Dec 2019. 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 Austria. 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?
Accuracy of ultra-low-dose-CT of the chest and plain film of the chest (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03922516, which also lists 35 linked publications.
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 19 Dec 2019.