RadiationNCT03581110
CODP Imaging From a Dose Perspective
An observational study of Radiation, run by Universitätsmedizin Mannheim.
Trial summary
The noncontrast-enhanced chest computed tomography (CT) is an emerging diagnostical tool in patient with chronic obstructive pulmonary disease (COPD). As shown in previous studies and pointed out by the Fleischner society, an additional scan in expiration reflects the pathophysiology of this complex disease better and… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Radiation
- What is being tested?
- computed tomography
- How many people
- 1,957 participants
- Where
- No sites listed yet
- Study dates
- Aug 2014to Sep 2017
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The data was acquired retrospectively, by analyzing CT scans performed between August 2014 and September 2017. Further, the three different study groups have retrospectively been matched using the water equivalent diameter (WED). A difference of 5% was desired to eliminate a size related bias in the effective organ dose calculation.
Who may be able to join
- noncontrast-enhanced chest CT performed on one of the named devices
- imaging performed between August 2014 and September 2017
- CT protocol used as previously specified
Who cannot join
- -
About this study
Official title: CODP Imaging From a Dose Perspective - Effective Organ Doses of a Combined Inspiration-expiration Protocol on a 3rd Generation Dual-source CT
The noncontrast-enhanced chest computed tomography (CT) is an emerging diagnostical tool in patient with chronic obstructive pulmonary disease (COPD). As shown in previous studies and pointed out by the Fleischner society, an additional scan in expiration reflects the pathophysiology of this complex disease better and extends the clinical information of the CT.
Nevertheless, this scan is leading to an increase in radiation dose. But currently it is unclear if this increased radiation dose is proportional to the additional clinical value when compared to inspiration-only protocols. Therefore, the aim of this study was to compare the organ specific radiation doses of a combined inspiration-expiration CT on a 3rd generation dual-source scanner with noncontrast-enhanced chest CTs of two clinical routine scanners. Therefore, the radiation doses of nearly 2000 chest CTs have been evaluated.
- Conditions
- Radiation
- Being tested
- computed tomography
- Keywords
- COPD, Computed tomography, Expiration, organ specific radiation dose
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
computed tomographyDiagnostic test
noncontrast-enhanced chest computed tomography
| Study group | Role | What they receive |
|---|---|---|
| 16-slice CT scanner | 1426 patients that have received a noncontrast-enhanced chest CT on our 16-slice clinical routine CT scanner in inspiration only. Receives: Diagnostic Test: computed tomography | |
| 2nd generation dual-source CT | 320 patients that have received a noncontrast-enhanced chest CT on our second generation dual-source CT scanner in inspiration only. Receives: Diagnostic Test: computed tomography | |
| 3rd generation dual-source CT | 211 patients that have received a noncontrast-enhanced chest CT on our third generation dual-source CT scanner in inspiration and expiration. Receives: Diagnostic Test: computed tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
organ specific radiation doses
Organ specific radiation doses of 17 individual organs
Measured: The organ dose calculations have been performed retrospectively. Therefore, the time frame is variable. The time set for the final outcome calculations was September 2017. Therefore, the time frame varies between 3 years and 1 week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2018
- Study startAug 2014
- Primary completionSep 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for RadiationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,957 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsmedizin Mannheim
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joshua Gawlitza, Universitätsmedizin Mannheim
- Investigators
- Joshua FM Gawlitza, MD, Principal investigator, University medical center MannheimHolger Haubenreisser, MD, Principal investigator, University medical center MannheimFrederik Trinkmann, MD, Principal investigator, University medical center Mannheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03581110
- Sponsor's protocol ID
- UMannheim
- Status last verified
- Jul 2018
- First submitted
- 22 Jun 2018
- Last updated
- 10 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Coxson HO, Dirksen A, Edwards LD, Yates JC, Agusti A, Bakke P, Calverley PM, Celli B, Crim C, Duvoix A, Fauerbach PN, Lomas DA, Macnee W, Mayer RJ, Miller BE, Muller NL, Rennard SI, Silverman EK, Tal-Singer R, Wouters EF, Vestbo J; Evaluation of COPD Longitudinally to Identify Predictive Surrogate Endpoints (ECLIPSE) Investigators. The presence and progression of emphysema in COPD as determined by CT scanning and biomarker expression: a prospective analysis from the ECLIPSE study. Lancet Respir Med. 2013 Apr;1(2):129-36. doi: 10.1016/S2213-2600(13)70006-7. Epub 2013 Feb 1.
PubMed 24429093Gawlitza J, Trinkmann F, Scheffel H, Fischer A, Nance JW, Henzler C, Vogler N, Saur J, Akin I, Borggrefe M, Schoenberg SO, Henzler T. Time to Exhale: Additional Value of Expiratory Chest CT in Chronic Obstructive Pulmonary Disease. Can Respir J. 2018 Mar 4;2018:9493504. doi: 10.1155/2018/9493504. eCollection 2018.
PubMed 29686742Haubenreisser 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 26001437Gordic S, Morsbach F, Schmidt B, Allmendinger T, Flohr T, Husarik D, Baumueller S, Raupach R, Stolzmann P, Leschka S, Frauenfelder T, Alkadhi H. Ultralow-dose chest computed tomography for pulmonary nodule detection: first performance evaluation of single energy scanning with spectral shaping. Invest Radiol. 2014 Jul;49(7):465-73. doi: 10.1097/RLI.0000000000000037.
PubMed 24598443Braun 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 25515204
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CODP Imaging From a Dose Perspective - Effective Organ Doses of a Combined Inspiration-expiration Protocol on a 3rd Generation Dual-source CT
- ClinicalTrials.gov ID
- NCT03581110
- Acronym / sponsor ID
- UMannheim
- Conditions
- Radiation
- Keywords
- COPD, Computed tomography, Expiration, organ specific radiation dose
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,957 participants (actual)
- Lead sponsor
- Universitätsmedizin MannheimUniversity, hospital or other
- Study start
- Aug 2014 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 10 Jul 2018 (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.
The noncontrast-enhanced chest computed tomography (CT) is an emerging diagnostical tool in patient with chronic obstructive pulmonary disease (COPD). As shown in previous studies and pointed out by the Fleischner society, an additional scan in expiration reflects the pathophysiology of this complex disease better and extends the clinical information of the CT.
Nevertheless, this scan is leading to an increase in radiation dose. But currently it is unclear if this increased radiation dose is proportional to the additional clinical value when compared to inspiration-only protocols. Therefore, the aim of this study was to compare the organ specific radiation doses of a combined inspiration-expiration CT on a 3rd generation dual-source scanner with noncontrast-enhanced chest CTs of two clinical routine scanners. Therefore, the radiation doses of nearly 2000 chest CTs have been evaluated.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 16-slice CT scanner | – | Diagnostic Test: computed tomography1426 patients that have received a noncontrast-enhanced chest CT on our 16-slice clinical routine CT scanner in inspiration only. |
| 2nd generation dual-source CT | – | Diagnostic Test: computed tomography320 patients that have received a noncontrast-enhanced chest CT on our second generation dual-source CT scanner in inspiration only. |
| 3rd generation dual-source CT | – | Diagnostic Test: computed tomography211 patients that have received a noncontrast-enhanced chest CT on our third generation dual-source CT scanner in inspiration and expiration. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The data was acquired retrospectively, by analyzing CT scans performed between August 2014 and September 2017. Further, the three different study groups have retrospectively been matched using the water equivalent diameter (WED). A difference of 5% was desired to eliminate a size related bias in the effective organ dose calculation.
Key inclusion criteria (3 listed)
- noncontrast-enhanced chest CT performed on one of the named devices
- imaging performed between August 2014 and September 2017
- CT protocol used as previously specified
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| computed tomographynoncontrast-enhanced chest computed tomography | Diagnostic test | 16-slice CT scanner, 2nd generation dual-source CT, 3rd generation dual-source CT |
Primary outcome
organ specific radiation doses
Time frame: The organ dose calculations have been performed retrospectively. Therefore, the time frame is variable. The time set for the final outcome calculations was September 2017. Therefore, the time frame varies between 3 years and 1 week.
Organ specific radiation doses of 17 individual organs
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 10 Jul 2018.
- Background: PubMed 24429093Coxson HO, Dirksen A, Edwards LD, Yates JC, Agusti A, Bakke P, Calverley PM, Celli B, Crim C, Duvoix A, Fauerbach PN, Lomas DA, Macnee W, Mayer RJ, Miller BE, Muller NL, Rennard SI, Silverman EK, Tal-Singer R, Wouters EF, Vestbo J; Evaluation of COPD Longitudinally to Identify Predictive Surrogate Endpoints (ECLIPSE) Investigators. The presence and progression of emphysema in COPD as determined by CT scanning and biomarker expression: a prospective analysis from the ECLIPSE study. Lancet Respir Med. 2013 Apr;1(2):129-36. doi: 10.1016/S2213-2600(13)70006-7. Epub 2013 Feb 1.
- Background: PubMed 29686742Gawlitza J, Trinkmann F, Scheffel H, Fischer A, Nance JW, Henzler C, Vogler N, Saur J, Akin I, Borggrefe M, Schoenberg SO, Henzler T. Time to Exhale: Additional Value of Expiratory Chest CT in Chronic Obstructive Pulmonary Disease. Can Respir J. 2018 Mar 4;2018:9493504. doi: 10.1155/2018/9493504. eCollection 2018.
- 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 24598443Gordic S, Morsbach F, Schmidt B, Allmendinger T, Flohr T, Husarik D, Baumueller S, Raupach R, Stolzmann P, Leschka S, Frauenfelder T, Alkadhi H. Ultralow-dose chest computed tomography for pulmonary nodule detection: first performance evaluation of single energy scanning with spectral shaping. Invest Radiol. 2014 Jul;49(7):465-73. doi: 10.1097/RLI.0000000000000037.
- 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.
- Individual participant dataSharing planned: No
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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.
Joshua FM Gawlitza, MD principal investigator
University medical center Mannheim
Holger Haubenreisser, MD principal investigator
University medical center Mannheim
Frederik Trinkmann, MD principal investigator
University medical center Mannheim
Questions about this trial
What is this clinical trial studying?
An observational study of Radiation, run by Universitätsmedizin Mannheim.
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 1 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 10 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
organ specific radiation doses (time frame: The organ dose calculations have been performed retrospectively. Therefore, the time frame is variable. The time set for the final outcome calculations was September 2017. Therefore, the time frame varies between 3 years and 1 week.). 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 NCT03581110, which also lists 5 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 10 Jul 2018.