Clinical trial NCT03581110: CODP Imaging From a Dose Perspective
Official title: CODP Imaging From a Dose Perspective - Effective Organ Doses of a Combined Inspiration-expiration Protocol on a 3rd Generation Dual-source CT
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Radiation
Keywords: COPD
Computed tomography
Expiration
organ specific radiation dose
Lead sponsor: Universitätsmedizin Mannheim
Sponsor class: OTHER
First posted: 2018-07-10
Enrollment: 1957
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The data was acquired retrospectively, by analyzing CT scans performed between August 2014 and September 2017. Further, the three different study groups have retrospectively been matched using the water equivalent diameter (WED). A difference of 5% was desired to eliminate a size related bias in the effective organ dose calculation.

Brief summary: 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.


Eligibility criteria: 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:

-

Primary outcomes:
measure: organ specific radiation doses
timeFrame: The organ dose calculations have been performed retrospectively. Therefore, the time frame is variable. The time set for the final outcome calculations was September 2017. Therefore, the time frame varies between 3 years and 1 week.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University medical center Mannheim
name: Joshua FM Gawlitza, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University medical center Mannheim
name: Holger Haubenreisser, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University medical center Mannheim
name: Frederik Trinkmann, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
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citation: 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.