- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02611947
CT Indexes of Emphysema and Airways in Healthy Volunteers: Normal Values; Relations With Gender, Height and Weight
연구 개요
상세 설명
87 healthy volunteers performed consecutively a low-dose chest CT scan and pulmonary function tests:
On chest CT scans, indexes reflecting pulmonary emphysema and airways measurements have been computed by using dedicated softwares. Each of our three readers performed two reading sessions.
Relative area of lung parenchyma with attenuation value less than -960 Hounsfield Units; luminal area and wall thickness in third and fourth generations airways were recorded.
- Pulmonary function tests were performed: vital capacity, forced vital capacity , functional residual capacity, total lung capacity, residual volume, forced expiratory volume in one second, and diffusion lung capacity for carbon monoxide were recorded (either in absolute values and percentage of predicted values).
CT indexes were compared with gender, height and weight.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
-
-
-
Brussels, 벨기에, 1070
- Erasme University Hospital
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Never smoked.
- No respiratory infection in the 4 weeks before the begin of the study.
- No history of pulmonary resection.
- No active malignancy or malignancy of any organ system within the past 5 years.
Exclusion Criteria:
- no exclusion criteria
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
---|---|
Healthy Volunteers
Inclusion criteria:
|
Supine chest CT scan after full inspiration. Acquisition parameters: (Topogram 35 mA 120 kV 512 mm length) 35 quality ref mAs with care-dose ON 120 kV Pitch 1.4 Rotation time 0.33 s Acquired images 64 x 0.6 mm |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
CT index - RA960 (%)
기간: 4 hours
|
From acquired data, images were reconstructed using a soft algorithm.
On these soft images, the relative area of lung parenchyma with attenuation value less than -960 Hounsfield Units was computed (expressed in %), as an index representative of pulmonary emphysema extent.
|
4 hours
|
CT index - LA3rd (mm2)
기간: 4 hours
|
From acquired data, images were reconstructed using a high resolution algorithm.
On these high-resolution images, the airway lumen was measured in third generations of airways (expressed in mm2).
|
4 hours
|
CT index - LA4th (mm2)
기간: 4 hours
|
From acquired data, images were reconstructed using a high resolution algorithm.
On these high-resolution images, the airway lumen was measured in fourth generations of airways (expressed in mm2).
|
4 hours
|
CT index - WT3rd (mm)
기간: 4 hours
|
From acquired data, images were reconstructed using a high resolution algorithm.
On these high-resolution images, the airway wall was measured in third generations of airways (expressed in mm).
|
4 hours
|
CT index - WT4th (mm)
기간: 4 hours
|
From acquired data, images were reconstructed using a high resolution algorithm.
On these high-resolution images, the airway wall was measured in fourth generations of airways (expressed in mm).
|
4 hours
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Pulmonary function tests - VC (l)
기간: 4 hours
|
Vital capacity was measured (expressed in l).
|
4 hours
|
Pulmonary function tests - FVC (l)
기간: 4 hours
|
Forced vital capacity was measured (expressed in l).
|
4 hours
|
Pulmonary function tests - FRC (l)
기간: 4 hours
|
Functional residual capacity capacity was measured (expressed in l).
|
4 hours
|
Pulmonary function tests - TLC (l)
기간: 4 hours
|
Total lung capacity was measured (expressed in l).
|
4 hours
|
Pulmonary function tests - RV (l)
기간: 4 hours
|
Residual volume was measured (expressed in l).
|
4 hours
|
Pulmonary function tests - FEV1 (l)
기간: 4 hours
|
Forced expiratory volume in one second was measured (expressed in l).
|
4 hours
|
Pulmonary function tests - DLCO (ml/min/ mmHg)
기간: 4 hours
|
Diffusion lung capacity for carbon monoxide was measured (expressed in ml/min/ mmHg)
|
4 hours
|
공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- Madani A, Zanen J, de Maertelaer V, Gevenois PA. Pulmonary emphysema: objective quantification at multi-detector row CT--comparison with macroscopic and microscopic morphometry. Radiology. 2006 Mar;238(3):1036-43. doi: 10.1148/radiol.2382042196. Epub 2006 Jan 19.
- Madani A, De Maertelaer V, Zanen J, Gevenois PA. Pulmonary emphysema: radiation dose and section thickness at multidetector CT quantification--comparison with macroscopic and microscopic morphometry. Radiology. 2007 Apr;243(1):250-7. doi: 10.1148/radiol.2431060194.
- Hackx M, Bankier AA, Gevenois PA. Chronic obstructive pulmonary disease: CT quantification of airways disease. Radiology. 2012 Oct;265(1):34-48. doi: 10.1148/radiol.12111270.
- Hackx M, Gyssels E, Severo Garcia T, De Meulder I, Alard S, Bruyneel M, Van Muylem A, Ninane V, Gevenois PA. Chronic Obstructive Pulmonary Disease: CT Quantification of Airway Dimensions, Numbers of Airways to Measure, and Effect of Bronchodilation. Radiology. 2015 Dec;277(3):853-62. doi: 10.1148/radiol.2015140949. Epub 2015 May 19.
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 연구와 관련된 용어
기타 연구 ID 번호
- P2010/175
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