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Comparison of the Ultra-low-dose Veo Algorithm With the Gold Standard Filtered Back Projection for Detecting Pulmonary Asbestos-related Conditions

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ClinicalTrials.gov Identifier: NCT01955018
Recruitment Status : Completed
First Posted : October 7, 2013
Last Update Posted : October 7, 2013
Sponsor:
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

Study Description
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Brief 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. 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.


Condition or disease Intervention/treatment Phase
Asbestos-exposed Workers Device: New algorithm called VeoTM (General Electric Healthcare, Milwaukee, MI, USA) Phase 4

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: Comparison of the Ultra-low-dose Veo Algorithm With the Gold Standard Filtered Back Projection for Detecting Pulmonary Asbestos-related Conditions
Study Start Date : September 2012
Actual Primary Completion Date : April 2013
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asbestos

Arms and Interventions
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Arm Intervention/treatment
Experimental: VeoTM
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
 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.
gold standard FBP model
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: 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Radiation dose [ Time Frame: at day 1 ]
    The dose length product (DLP) will be recorded.

  2. Quality images assessment [ Time Frame: at day 1 ]

    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.



Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • asbestos-exposed workers
  • ability to give a written informed consent

Exclusion Criteria:

  • - previous history of cancer
  • previous history of thoracic surgery
  • other interstitial pathology known
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01955018


Locations
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France
CHU Clermont-Ferrand
Clermont-Ferrand, France, 63003
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
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Principal Investigator: Frederic DUTHEIL University Hospital, Clermont-Ferrand
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT01955018    
Other Study ID Numbers: CHU-0166
2012-A00618-35
First Posted: October 7, 2013    Key Record Dates
Last Update Posted: October 7, 2013
Last Verified: September 2013
Keywords provided by University Hospital, Clermont-Ferrand:
computed tomography
radiation
screening
 asbestos
workers
cancer