CODP Imaging From a Dose Perspective

NCT03581110 | Completed FDA Device

• 1 other identifier: UMannheim
• Study Type: observational
• Target: 1,957
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Radiation

Keywords

COPD; Computed tomography; Expiration; organ specific radiation dose

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (3)

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

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

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

Interventions

computed tomography DIAGNOSTIC_TEST

noncontrast-enhanced chest computed tomography

16-slice CT scanner; 2nd generation dual-source CT; 3rd generation dual-source CT

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

Sponsors & Collaborators

• Universitätsmedizin Mannheim: lead

Related Publications (5)

• 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.

  PMID: 24429093 BACKGROUND

• 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.

  PMID: 29686742 BACKGROUND

• 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.

  PMID: 26001437 BACKGROUND

• 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.

  PMID: 24598443 BACKGROUND

• 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.

  PMID: 25515204 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Death

Interventions

Tomography, X-Ray Computed

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Tomography

Study Officials

• Joshua FM Gawlitza, MD

  University medical center Mannheim

  PRINCIPAL INVESTIGATOR

• Holger Haubenreisser, MD

  University medical center Mannheim

  PRINCIPAL INVESTIGATOR

• Frederik Trinkmann, MD

  University medical center Mannheim

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of COPD imaging research

Study Record Dates

• First Submitted: June 22, 2018
• First Posted: July 10, 2018
• Study Start: August 1, 2014
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: July 10, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share