Clinical trial NCT02611947: CT Indexes of Emphysema and Airways in Healthy Volunteers: Normal Values; Relations With Gender, Height and Weight
Official title: CT Indexes of Emphysema and Airways in Healthy Volunteers: Normal Values; Relations With Gender, Height and Weight
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: emphysema
airway remodelling
multidetector computed tomography
Lead sponsor: Erasme University Hospital
Sponsor class: OTHER
First posted: 2015-11-23
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy Volunteers

Brief summary: Various indexes have been proposed to quantify both pulmonary emphysema and airways disease on chest CT scans. It is unknown whether these indexes should be consider in absolute values or as compared to predicted normal values. The purposes of the present study is thus : a) to measure these indexes at CT in healthy volunteers; b) to investigate their relations with gender, height and weight.

Detailed description: 87 healthy volunteers performed consecutively a low-dose chest CT scan and pulmonary function tests:

1. 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.
2. 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.

Eligibility criteria: 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

Primary outcomes:
measure: CT index - RA960 (%)
timeFrame: 4 hours
measure: CT index - LA3rd (mm2)
timeFrame: 4 hours
measure: CT index - LA4th (mm2)
timeFrame: 4 hours
measure: CT index - WT3rd (mm)
timeFrame: 4 hours
measure: CT index - WT4th (mm)
timeFrame: 4 hours
Secondary outcomes:
measure: Pulmonary function tests - VC (l)
timeFrame: 4 hours
measure: Pulmonary function tests - FVC (l)
timeFrame: 4 hours
measure: Pulmonary function tests - FRC (l)
timeFrame: 4 hours
measure: Pulmonary function tests - TLC (l)
timeFrame: 4 hours
measure: Pulmonary function tests - RV (l)
timeFrame: 4 hours
measure: Pulmonary function tests - FEV1 (l)
timeFrame: 4 hours
measure: Pulmonary function tests - DLCO (ml/min/ mmHg)
timeFrame: 4 hours
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Erasme University Hospital
Study officials:
affiliation: Erasme University Hospital
name: Pierre Alain GEVENOIS, MD, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.