- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT02611947
CT Indexes of Emphysema and Airways in Healthy Volunteers: Normal Values; Relations With Gender, Height and Weight
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Kontakte und Standorte
Studienorte
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Brussels, Belgien, 1070
- Erasme University Hospital
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
---|---|
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 |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
CT index - RA960 (%)
Zeitfenster: 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.
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4 hours
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CT index - LA3rd (mm2)
Zeitfenster: 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).
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4 hours
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CT index - LA4th (mm2)
Zeitfenster: 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).
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4 hours
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CT index - WT3rd (mm)
Zeitfenster: 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)
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Pulmonary function tests - VC (l)
Zeitfenster: 4 hours
|
Vital capacity was measured (expressed in l).
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4 hours
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Pulmonary function tests - FVC (l)
Zeitfenster: 4 hours
|
Forced vital capacity was measured (expressed in l).
|
4 hours
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Pulmonary function tests - FRC (l)
Zeitfenster: 4 hours
|
Functional residual capacity capacity was measured (expressed in l).
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4 hours
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Pulmonary function tests - TLC (l)
Zeitfenster: 4 hours
|
Total lung capacity was measured (expressed in l).
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4 hours
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Pulmonary function tests - RV (l)
Zeitfenster: 4 hours
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Residual volume was measured (expressed in l).
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4 hours
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Pulmonary function tests - FEV1 (l)
Zeitfenster: 4 hours
|
Forced expiratory volume in one second was measured (expressed in l).
|
4 hours
|
Pulmonary function tests - DLCO (ml/min/ mmHg)
Zeitfenster: 4 hours
|
Diffusion lung capacity for carbon monoxide was measured (expressed in ml/min/ mmHg)
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4 hours
|
Mitarbeiter und Ermittler
Sponsor
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- 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.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- P2010/175
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