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CompletedNCT02611947Updated Nov 23, 2015

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

An observational study in Healthy, sponsored by Erasme University Hospital. Completed at 1 site in Belgium. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-11-23.

Sponsored by Erasme University Hospital · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
87
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Healthy

Keywords

  • emphysema
  • airway remodelling
  • multidetector computed tomography
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In context

Pulmonary Emphysema

187 studies on the registry are indexed under Pulmonary Emphysema; 19 are open to participants now.

This study's enrollment of 87 is above the median of 74 across 48 observational studies indexed under Pulmonary Emphysema.

Browse Pulmonary Emphysema studies →

Lead sponsor

Erasme University Hospital is the lead sponsor of 178 studies on the registry; 34 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Healthy Volunteers

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

Exclusion Criteria:

  • no exclusion criteria
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
87 participants (actual)
Patient registry
No

Groups and cohorts

  • Healthy Volunteers

    Inclusion criteria: 1. Aged 18 or more. 2. Never smoked. 3. No respiratory infection in the 4 weeks before the begin of the study. 4. No history of pulmonary resection. 5. No active malignancy or malignancy of any organ system within the past 5 years.

    Radiation: Low-dose chest CT scans

Interventions

  • RadiationLow-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

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 4 hours

  2. 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).

    Time frame: 4 hours

  3. 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).

    Time frame: 4 hours

  4. 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).

    Time frame: 4 hours

  5. 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).

    Time frame: 4 hours

Secondary outcomes

  1. Pulmonary function tests - VC (l)

    Vital capacity was measured (expressed in l).

    Time frame: 4 hours

  2. Pulmonary function tests - FVC (l)

    Forced vital capacity was measured (expressed in l).

    Time frame: 4 hours

  3. Pulmonary function tests - FRC (l)

    Functional residual capacity capacity was measured (expressed in l).

    Time frame: 4 hours

  4. Pulmonary function tests - TLC (l)

    Total lung capacity was measured (expressed in l).

    Time frame: 4 hours

  5. Pulmonary function tests - RV (l)

    Residual volume was measured (expressed in l).

    Time frame: 4 hours

  6. Pulmonary function tests - FEV1 (l)

    Forced expiratory volume in one second was measured (expressed in l).

    Time frame: 4 hours

  7. Pulmonary function tests - DLCO (ml/min/ mmHg)

    Diffusion lung capacity for carbon monoxide was measured (expressed in ml/min/ mmHg)

    Time frame: 4 hours

07

Study locations

1 site
  • Erasme University Hospital
    Brussels, 1070, Belgium
08

References and documents

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. PubMed 16424242 ↗
  • 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. PubMed 17392257 ↗
  • 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. PubMed 22993219 ↗
  • 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. PubMed 25989594 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 23, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02611947
Lead sponsor
Erasme University Hospital
Responsible party
Sponsor
First posted
Nov 23, 2015
Start date
Oct 2010
Primary completion
Jun 2011
Completion
Jun 2011
Last update
Nov 23, 2015

Study contacts

Pierre Alain GEVENOIS, MD, PhD
study director · Erasme University Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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