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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02611947
• Other study ID #: P2010/175
• Status: Completed
• Phase: N/A
• First received: October 30, 2015
• Last updated: November 19, 2015
• Start date: October 2010
• Est. completion date: June 2011

Study information

• Verified date: November 2015
• Source: Erasme University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Emphysema
• Healthy

Intervention

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

Locations

Country	Name	City	State
Belgium	Erasme University Hospital	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Erasme University Hospital

Country where clinical trial is conducted

Belgium, 

References & Publications (4)

Hackx M, Bankier AA, Gevenois PA. Chronic obstructive pulmonary disease: CT quantification of airways disease. Radiology. 2012 Oct;265(1):34-48. Review. — View 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. — View 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. — View 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. Epub 2006 Jan 19. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	Pulmonary function tests - VC (l)	Vital capacity was measured (expressed in l).	4 hours	No
Secondary	Pulmonary function tests - FVC (l)	Forced vital capacity was measured (expressed in l).	4 hours	No
Secondary	Pulmonary function tests - FRC (l)	Functional residual capacity capacity was measured (expressed in l).	4 hours	No
Secondary	Pulmonary function tests - TLC (l)	Total lung capacity was measured (expressed in l).	4 hours	No
Secondary	Pulmonary function tests - RV (l)	Residual volume was measured (expressed in l).	4 hours	No
Secondary	Pulmonary function tests - FEV1 (l)	Forced expiratory volume in one second was measured (expressed in l).	4 hours	No
Secondary	Pulmonary function tests - DLCO (ml/min/ mmHg)	Diffusion lung capacity for carbon monoxide was measured (expressed in ml/min/ mmHg)	4 hours	No