CT Indexes of Emphysema and Airways in Healthy Volunteers: Normal Values; Relations With Gender, Height and Weight

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Radiation: Low-dose chest CT scans

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.

• Study Type: Observational
• Enrollment (Actual): 87

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1070
    • Erasme University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Healthy Volunteers

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy Volunteers; Inclusion criteria: Aged 18 or more.; 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.	Radiation: Low-dose chest CT scans; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CT index - RA960 (%)	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)	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)	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)	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)	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pulmonary function tests - VC (l)	Vital capacity was measured (expressed in l).	4 hours
Pulmonary function tests - FVC (l)	Forced vital capacity was measured (expressed in l).	4 hours
Pulmonary function tests - FRC (l)	Functional residual capacity capacity was measured (expressed in l).	4 hours
Pulmonary function tests - TLC (l)	Total lung capacity was measured (expressed in l).	4 hours
Pulmonary function tests - RV (l)	Residual volume was measured (expressed in l).	4 hours
Pulmonary function tests - FEV1 (l)	Forced expiratory volume in one second was measured (expressed in l).	4 hours
Pulmonary function tests - DLCO (ml/min/ mmHg)	Diffusion lung capacity for carbon monoxide was measured (expressed in ml/min/ mmHg)	4 hours

Collaborators and Investigators

• Sponsor: Erasme University Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: October 30, 2015
• First Submitted That Met QC Criteria: November 19, 2015
• First Posted (Estimate): November 23, 2015

Study Record Updates

• Last Update Posted (Estimate): November 23, 2015
• Last Update Submitted That Met QC Criteria: November 19, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: emphysema; airway remodelling; multidetector computed tomography
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Pulmonary Emphysema; Emphysema
• Other Study ID Numbers: P2010/175