Comparison of the Ultra-low-dose Veo Algorithm With the Gold Standard Filtered Back Projection for Detecting Pulmonary Asbestos-related Conditions
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.
연구 개요
상태
상세 설명
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).
연구 유형
등록 (실제)
단계
- 4단계
연락처 및 위치
연구 장소
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Clermont-Ferrand, 프랑스, 63003
- Chu Clermont-Ferrand
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 특수 증상
- 할당: 무작위
- 중재 모델: 단일 그룹 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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
|
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.
|
|
다른: 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
|
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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Pleural and parenchymal abnormalities
기간: at day 1
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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.
|
at day 1
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Radiation dose
기간: at day 1
|
The dose length product (DLP) will be recorded.
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at day 1
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Quality images assessment
기간: at day 1
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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. |
at day 1
|
공동 작업자 및 조사자
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .