Asbestos-exposed WorkersPhase 4NCT01955018
Comparison of the Ultra-low-dose Veo Algorithm With the Gold Standard Filtered Back Projection for Detecting Pulmonary Asbestos-related Conditions
A Phase 4 study testing New algorithm called VeoTM (General Electric Healthcare, Milwaukee, MI, USA) in people with Asbestos-exposed Workers, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Asbestos fibers were intensively used throughout the 20th century and remain prevalent in developing countries. However, asbestos exposure induces a variety of benign and malignant pleural and lung diseases. The most common asbestos-induced neoplasm is lung cancer. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Asbestos-exposed Workers
- What is being tested?
- New algorithm called VeoTM (General Electric Healthcare, Milwaukee, MI, USA)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2012to May 2013
- Phase
- Phase 4
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- asbestos-exposed workers
- ability to give a written informed consent
Who cannot join
- - previous history of cancer
- previous history of thoracic surgery
- other interstitial pathology known
Trial locations and contacts
1 site in 1 country.
About this study
Asbestos fibers were intensively used throughout the 20th century and remain prevalent in developing countries. However, asbestos exposure induces a variety of benign and malignant pleural and lung diseases. The most common asbestos-induced neoplasm is lung cancer. Moreover, thin-section computed tomography (CT) is more sensitive than a chest x-ray for detecting early asbestos-related conditions. Increased exposure to radiation underpins the consequences of cancer induction. However, reducing CT doses increases image noise from the filtered back projection (FBP) reconstruction. Strategies to reduce radiation exposure include the use of iterative reconstruction algorithms. A new algorithm called VeoTM (General Electric Healthcare, Milwaukee, MI, USA) decreases the image noise up to 70% compared with the gold standard FBP model. Moreover, Veo improves spatial resolution with excellent detection of low and high contrast objects from a CT Dose Index (CTDIvol) equal to 0.3 mGy.
The objective of the present study is to compare Veo with the gold standard FBP for detecting pulmonary asbestos-related conditions among workers previously exposed to asbestos. Comparisons included radiation delivered and image quality.
Read the detailed description
Asbestos-exposed workers will be recruited following referral to our radiology department for the evaluation of asbestos-related disease. CT examinations will be performed with a 64-slice CT system (Discovery CT 750HD; GE Healthcare, Milwaukee, WI) and will consist of two successive acquisitions. Each examination, the normal-dose (FBP acquisition) and ultra-low-dose (Veo acquisition) spiral CT, will be performed in supine position, on the entire thorax, at full inspiration and without contrast agent injection.
In order to perform the two acquisitions without increasing radiation, standard acquisition will be performed with the same kV with mA equal to patient's body weight minus 10. To conserve image quality, 60 mA will be the inferior limit. The other CT parameters will be rotation time 0.5 s and pitch 1.375. Image data will be reconstructed with FBP algorithm.
The Veo acquisition will be performed with constant CT parameters including: a tube voltage of 100 kV, a tube current of 20 mA, pitch of 0.984 and rotation time 0.4 s. Image data will be reconstructed with the Veo algorithm.
Each CT acquisition will be viewed independently by two experienced radiologists (2 to 7 years of experience). The low-dose images with Veo reconstruction will be interpreted before the standard CT and on separate weeks to minimize recall bias. Then, the more experienced radiologist will evaluate the detection and characterization of pleuroparenchymal abnormalities by a second and simultaneous reading of the Veo and FBP acquisitions. Because FBP images are benchmark practice, when a lesion will be found only on Veo images, it will be regarded as a false positive.
The following asbestos-related pleural and parenchymal abnormalities will be recorded as present or absent. Pleural abnormalities considered will be: pleural plaques, diffuse pleural thickening and pleural effusion.
CT features of asbestosis will include subpleural dots and branching opacities, curvilinear subpleural lines, areas of ground glass opacities, septal lines, reticulations and honeycombing.
Presence of nodules will also be recorded. We will note for each abnormality: localization (side, table position) and nature (non-solid, part-solid, solid or calcified).
- Conditions
- Asbestos-exposed Workers
- Being tested
- New algorithm called VeoTM (General Electric Healthcare, Milwaukee, MI, USA)
- Keywords
- computed tomography, radiation, screening, asbestos, workers, cancer
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New algorithm called VeoTM (General Electric Healthcare, Milwaukee, MI, USA)Device
The objective of the present study is to compare Veo with the gold standard FBP for detecting pulmonary asbestos-related conditions among workers previously exposed to asbestos. Comparisons included radiation delivered and image quality.
| Study group | Role | What they receive |
|---|---|---|
| VeoTM | Experimental | A new algorithm called VeoTM (General Electric Healthcare, Milwaukee, MI, USA) decreases the image noise up to 70% compared with the gold standard FBP model. Moreover, Veo improves spatial resolution with excellent detection of low and high contrast objects from a CT Dose Index (CTDIvol) equal to 0.3 mGy Receives: Device: New algorithm called VeoTM (General Electric Healthcare, Milwaukee, MI, USA) |
| gold standard FBP model | Other | The objective of the present study is to compare Veo with the gold standard FBP for detecting pulmonary asbestos-related conditions among workers previously exposed to asbestos. Comparisons included radiation delivered and image quality Receives: Device: New algorithm called VeoTM (General Electric Healthcare, Milwaukee, MI, USA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pleural and parenchymal abnormalities
The kappa coefficient will be used to measure agreement for categorical parameters and Pearson's correlation coefficient and Lin concordance correlation coefficient for quantitative data.
Measured: at day 1
Secondary outcomes (2)
Radiation dose
The dose length product (DLP) will be recorded.
Measured: at day 1
Quality images assessment
Respiratory artifacts will be graded on a three-point scale (1 = negligible, 2 = moderate, 3 = salient).
Images noise will be studied in the axial and coronal planes. A similar scale will be used for subjective image quality in the mediastinum and parenchyma windows.
Objective image noise (Standard Deviation) and average CT numbers (in Hounsfield's units) will be measured with circular regions of interest (ROI) on different anatomical levels, 10 mm in diameter.
The signal to noise ratio (SNR) will also be calculated using the equation SNR = CT numbers / noise.
Measured: at day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2013 (estimated)
- Study startSep 2012
- Primary completionApr 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Asbestos-exposed WorkersStudies 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 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frederic DUTHEIL, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01955018
- Sponsor's protocol ID
- CHU-0166
- Other IDs
- 2012-A00618-35
- Status last verified
- Aug 2026
- First submitted
- 2 Sep 2013
- Last updated
- 7 Aug 2026
- Results posted
- No
Publications
Tekath M, Dutheil F, Bellini R, Roche A, Pereira B, Naughton G, Chamoux A, Michel JL. Comparison of the ultra-low-dose Veo algorithm with the gold standard filtered back projection for detecting pulmonary asbestos-related conditions: a clinical observational study. BMJ Open. 2014 May 30;4(5):e004980. doi: 10.1136/bmjopen-2014-004980.
PubMed 24879827
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Ultra-low-dose Veo Algorithm With the Gold Standard Filtered Back Projection for Detecting Pulmonary Asbestos-related Conditions
- ClinicalTrials.gov ID
- NCT01955018
- Acronym / sponsor ID
- CHU-0166
- Conditions
- Asbestos-exposed Workers
- Keywords
- computed tomography, radiation, screening, asbestos, workers, cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 7 Oct 2013 (estimated)
- 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.
Asbestos fibers were intensively used throughout the 20th century and remain prevalent in developing countries. However, asbestos exposure induces a variety of benign and malignant pleural and lung diseases. The most common asbestos-induced neoplasm is lung cancer. Moreover, thin-section computed tomography (CT) is more sensitive than a chest x-ray for detecting early asbestos-related conditions. Increased exposure to radiation underpins the consequences of cancer induction. However, reducing CT doses increases image noise from the filtered back projection (FBP) reconstruction. Strategies to reduce radiation exposure include the use of iterative reconstruction algorithms. A new algorithm called VeoTM (General Electric Healthcare, Milwaukee, MI, USA) decreases the image noise up to 70% compared with the gold standard FBP model. Moreover, Veo improves spatial resolution with excellent detection of low and high contrast objects from a CT Dose Index (CTDIvol) equal to 0.3 mGy.
The objective of the present study is to compare Veo with the gold standard FBP for detecting pulmonary asbestos-related conditions among workers previously exposed to asbestos. Comparisons included radiation delivered and image quality.
Detailed description
Asbestos-exposed workers will be recruited following referral to our radiology department for the evaluation of asbestos-related disease. CT examinations will be performed with a 64-slice CT system (Discovery CT 750HD; GE Healthcare, Milwaukee, WI) and will consist of two successive acquisitions. Each examination, the normal-dose (FBP acquisition) and ultra-low-dose (Veo acquisition) spiral CT, will be performed in supine position, on the entire thorax, at full inspiration and without contrast agent injection.
In order to perform the two acquisitions without increasing radiation, standard acquisition will be performed with the same kV with mA equal to patient's body weight minus 10. To conserve image quality, 60 mA will be the inferior limit. The other CT parameters will be rotation time 0.5 s and pitch 1.375. Image data will be reconstructed with FBP algorithm.
The Veo acquisition will be performed with constant CT parameters including: a tube voltage of 100 kV, a tube current of 20 mA, pitch of 0.984 and rotation time 0.4 s. Image data will be reconstructed with the Veo algorithm.
Each CT acquisition will be viewed independently by two experienced radiologists (2 to 7 years of experience). The low-dose images with Veo reconstruction will be interpreted before the standard CT and on separate weeks to minimize recall bias. Then, the more experienced radiologist will evaluate the detection and characterization of pleuroparenchymal abnormalities by a second and simultaneous reading of the Veo and FBP acquisitions. Because FBP images are benchmark practice, when a lesion will be found only on Veo images, it will be regarded as a false positive.
The following asbestos-related pleural and parenchymal abnormalities will be recorded as present or absent. Pleural abnormalities considered will be: pleural plaques, diffuse pleural thickening and pleural effusion.
CT features of asbestosis will include subpleural dots and branching opacities, curvilinear subpleural lines, areas of ground glass opacities, septal lines, reticulations and honeycombing.
Presence of nodules will also be recorded. We will note for each abnormality: localization (side, table position) and nature (non-solid, part-solid, solid or calcified).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VeoTM | Experimental | Device: New algorithm called VeoTM (General Electric Healthcare, Milwaukee, MI, USA)A new algorithm called VeoTM (General Electric Healthcare, Milwaukee, MI, USA) decreases the image noise up to 70% compared with the gold standard FBP model. Moreover, Veo improves spatial resolution with excellent detection of low and high contrast objects from a CT Dose Index (CTDIvol) equal to 0.3 mGy |
| gold standard FBP model | Other | Device: New algorithm called VeoTM (General Electric Healthcare, Milwaukee, MI, USA)The objective of the present study is to compare Veo with the gold standard FBP for detecting pulmonary asbestos-related conditions among workers previously exposed to asbestos. Comparisons included radiation delivered and image quality |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- asbestos-exposed workers
- ability to give a written informed consent
Key exclusion criteria (3 listed)
- - previous history of cancer
- previous history of thoracic surgery
- other interstitial pathology known
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 |
|---|---|---|
| New algorithm called VeoTM (General Electric Healthcare, Milwaukee, MI, USA)The objective of the present study is to compare Veo with the gold standard FBP for detecting pulmonary asbestos-related conditions among workers previously exposed to asbestos. Comparisons included radiation delivered and image quality. | Device | VeoTM, gold standard FBP model |
Primary outcome
Pleural and parenchymal abnormalities
Time frame: at day 1
The kappa coefficient will be used to measure agreement for categorical parameters and Pearson's correlation coefficient and Lin concordance correlation coefficient for quantitative data.
2 secondary outcomes
Radiation dose
Time frame: at day 1
Quality images assessment
Time frame: at day 1
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 7 Aug 2026.
- Results publication: PubMed 24879827Tekath M, Dutheil F, Bellini R, Roche A, Pereira B, Naughton G, Chamoux A, Michel JL. Comparison of the ultra-low-dose Veo algorithm with the gold standard filtered back projection for detecting pulmonary asbestos-related conditions: a clinical observational study. BMJ Open. 2014 May 30;4(5):e004980. doi: 10.1136/bmjopen-2014-004980.
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.
Frederic DUTHEIL principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing New algorithm called VeoTM (General Electric Healthcare, Milwaukee, MI, USA) in people with Asbestos-exposed Workers, run by University Hospital, Clermont-Ferrand at 1 site in France.
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 2 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 7 Aug 2026. 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 France. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Pleural and parenchymal abnormalities (time frame: at day 1). 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 NCT01955018, which also lists 1 linked publication.
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 7 Aug 2026.