CODP Imaging From a Dose Perspective

CODP Imaging From a Dose Perspective - Effective Organ Doses of a Combined Inspiration-expiration Protocol on a 3rd Generation Dual-source CT

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.

Study Overview

• Status: Completed
• Conditions: Radiation
• Intervention / Treatment: Diagnostic test: computed tomography

• Study Type: Observational
• Enrollment (Actual): 1957

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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:

-

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Diagnostic test: computed tomography; 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.	Diagnostic test: computed tomography; 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.	Diagnostic test: computed tomography; noncontrast-enhanced chest computed tomography

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
organ specific radiation doses	Organ specific radiation doses of 17 individual organs	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.

Collaborators and Investigators

• Sponsor: Universitätsmedizin Mannheim
• Investigators: Principal Investigator: Frederik Trinkmann, MD, University Medical Center Mannheim; Principal Investigator: Joshua FM Gawlitza, MD, University Medical Center Mannheim; Principal Investigator: Holger Haubenreisser, MD, University Medical Center Mannheim

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2014
• Primary Completion (Actual): September 1, 2017
• Study Completion (Actual): September 1, 2017

Study Registration Dates

• First Submitted: June 22, 2018
• First Submitted That Met QC Criteria: July 6, 2018
• First Posted (Actual): July 10, 2018

Study Record Updates

• Last Update Posted (Actual): July 10, 2018
• Last Update Submitted That Met QC Criteria: July 6, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: COPD; Computed tomography; Expiration; organ specific radiation dose
• Other Study ID Numbers: UMannheim

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No