CODP Imaging From a Dose Perspective

NCT ID: NCT03581110

Last Updated: 2018-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1957 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-08-31

Study Completion Date

2017-09-30

Brief Summary

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The noncontrast-enhanced chest computed tomography (CT) is an emerging diagnostical tool in patient with chronic obstructive pulmonary disease (COPD). As shown in previous studies and pointed out by the Fleischner society, an additional scan in expiration reflects the pathophysiology of this complex disease better and extends the clinical information of the CT.

Nevertheless, this scan is leading to an increase in radiation dose. But currently it is unclear if this increased radiation dose is proportional to the additional clinical value when compared to inspiration-only protocols. Therefore, the aim of this study was to compare the organ specific radiation doses of a combined inspiration-expiration CT on a 3rd generation dual-source scanner with noncontrast-enhanced chest CTs of two clinical routine scanners. Therefore, the radiation doses of nearly 2000 chest CTs have been evaluated.

Detailed Description

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Conditions

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Radiation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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16-slice CT scanner

1426 patients that have received a noncontrast-enhanced chest CT on our 16-slice clinical routine CT scanner in inspiration only.

computed tomography

Intervention Type DIAGNOSTIC_TEST

noncontrast-enhanced chest computed tomography

2nd generation dual-source CT

320 patients that have received a noncontrast-enhanced chest CT on our second generation dual-source CT scanner in inspiration only.

computed tomography

Intervention Type DIAGNOSTIC_TEST

noncontrast-enhanced chest computed tomography

3rd generation dual-source CT

211 patients that have received a noncontrast-enhanced chest CT on our third generation dual-source CT scanner in inspiration and expiration.

computed tomography

Intervention Type DIAGNOSTIC_TEST

noncontrast-enhanced chest computed tomography

Interventions

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computed tomography

noncontrast-enhanced chest computed tomography

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* noncontrast-enhanced chest CT performed on one of the named devices
* imaging performed between August 2014 and September 2017
* CT protocol used as previously specified

Exclusion Criteria

\-
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universitätsmedizin Mannheim

OTHER

Sponsor Role lead

Responsible Party

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Joshua Gawlitza

Head of COPD imaging research

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Joshua FM Gawlitza, MD

Role: PRINCIPAL_INVESTIGATOR

University medical center Mannheim

Holger Haubenreisser, MD

Role: PRINCIPAL_INVESTIGATOR

University medical center Mannheim

Frederik Trinkmann, MD

Role: PRINCIPAL_INVESTIGATOR

University medical center Mannheim

References

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Coxson HO, Dirksen A, Edwards LD, Yates JC, Agusti A, Bakke P, Calverley PM, Celli B, Crim C, Duvoix A, Fauerbach PN, Lomas DA, Macnee W, Mayer RJ, Miller BE, Muller NL, Rennard SI, Silverman EK, Tal-Singer R, Wouters EF, Vestbo J; Evaluation of COPD Longitudinally to Identify Predictive Surrogate Endpoints (ECLIPSE) Investigators. The presence and progression of emphysema in COPD as determined by CT scanning and biomarker expression: a prospective analysis from the ECLIPSE study. Lancet Respir Med. 2013 Apr;1(2):129-36. doi: 10.1016/S2213-2600(13)70006-7. Epub 2013 Feb 1.

Reference Type BACKGROUND
PMID: 24429093 (View on PubMed)

Gawlitza J, Trinkmann F, Scheffel H, Fischer A, Nance JW, Henzler C, Vogler N, Saur J, Akin I, Borggrefe M, Schoenberg SO, Henzler T. Time to Exhale: Additional Value of Expiratory Chest CT in Chronic Obstructive Pulmonary Disease. Can Respir J. 2018 Mar 4;2018:9493504. doi: 10.1155/2018/9493504. eCollection 2018.

Reference Type BACKGROUND
PMID: 29686742 (View on PubMed)

Haubenreisser H, Meyer M, Sudarski S, Allmendinger T, Schoenberg SO, Henzler T. Unenhanced third-generation dual-source chest CT using a tin filter for spectral shaping at 100kVp. Eur J Radiol. 2015 Aug;84(8):1608-1613. doi: 10.1016/j.ejrad.2015.04.018. Epub 2015 Apr 28.

Reference Type BACKGROUND
PMID: 26001437 (View on PubMed)

Gordic S, Morsbach F, Schmidt B, Allmendinger T, Flohr T, Husarik D, Baumueller S, Raupach R, Stolzmann P, Leschka S, Frauenfelder T, Alkadhi H. Ultralow-dose chest computed tomography for pulmonary nodule detection: first performance evaluation of single energy scanning with spectral shaping. Invest Radiol. 2014 Jul;49(7):465-73. doi: 10.1097/RLI.0000000000000037.

Reference Type BACKGROUND
PMID: 24598443 (View on PubMed)

Braun FM, Johnson TR, Sommer WH, Thierfelder KM, Meinel FG. Chest CT using spectral filtration: radiation dose, image quality, and spectrum of clinical utility. Eur Radiol. 2015 Jun;25(6):1598-606. doi: 10.1007/s00330-014-3559-1. Epub 2014 Dec 17.

Reference Type BACKGROUND
PMID: 25515204 (View on PubMed)

Other Identifiers

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UMannheim

Identifier Type: -

Identifier Source: org_study_id

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