Developing a lung nodule management protocol specifically for cardiac CT: Methodology in the DISCHARGE trial

Robert Haase, Jonathan D Dodd, Hans-Ulrich Kauczor, Ella A Kazerooni, Marc Dewey, Robert Haase, Jonathan D Dodd, Hans-Ulrich Kauczor, Ella A Kazerooni, Marc Dewey

Abstract

Purpose: In this methodology paper we describe the development of a lung nodule management algorithm specifically for patients undergoing cardiac CT.

Methods: We modified the Lung-RADS algorithm specifically to manage lung nodules incidentally detected on cardiac CT (Lung-RADS for cardiac CT). We will evaluate the modified algorithm as part of the DISCHARGE trial (www.dischargetrial.eu) in which patients with suspected coronary artery disease are randomly assigned to cardiac CT or invasive coronary angiography across Europe at 16 sites involving 3546 patients. Patients will be followed for up to four years.

Results: The major adjustments to Lung-RADS specifically for cardiac CT relate to 1) incomplete coverage of the lungs by cardiac CT compared with chest CT, and when to order a completion chest CT versus a follow up chest CT, 2) cardiac CT findings will not trigger annual lung-cancer screening, and 3) a lower threshold of at least 10 mm for classifying new ground glass nodules as probably benign (category 3).

Conclusions: The DISCHARGE trial will assess a lung nodule management algorithm designed specifically for cardiac CT in patients with stable chest pain across Europe.

Keywords: ACR, American College of Radiology; Adult; Computed tomography angiography*; Incidental findings*; LDCT, low-dose computed tomography; Lung/diagnostic imaging; NLST, national lung cancer screening trial; eCRF, electronic clinical report form.

© 2020 Published by Elsevier Ltd.

Figures

Fig. 1
Fig. 1
Management of lung nodules in DISCHARGE1. (1) Based on modifications to the Lung-RADS algorithm. (2) Mean diameter of longest and shortest diameters. (3) If prior was available. (4) Based on definitions from the glossary of terms for thoracic imaging (Hansell et al Radiology 2010). (5) Growth defined as >1.5 mm. (6) Risk factor examples include Risk features: Spiculation, mediastinal lymph nodes >1 cm small diameter, GGN that doubles in size in one year. (7) See main text for protocol details. (8) eCRF provides “Brock’ likelihood of malignancy calculation.
Fig. 2
Fig. 2
Subsections of the eCRF showing lung nodule data entry inputs along modified pathways specific for cardiac CT. A hypothetical example of an incidentally detected part-solid nodule on cardiac CT is provided. (A) The eCRF automatically calculates mean nodule size (arrow) from inputted long and short diameters. (B) Additional features suggestive of malignancy along with patient risk factors (arrow) can be inputted. In this hypothetical example the nodule would fulfill criteria for a Lung-RADS category 4x nodule. (C) A whole chest contrast-enhanced CT is recommended for this category, the findings of which can be inputted and the McWilliams calculator is available via an online link (arrow) to obtain a likelihood of nodule malignancy. In our hypothetical example it calculates a malignancy likelihood of 44.3 %. (D) For a nodule with a 44.3 % likelihood of malignancy a percutaneous CT-guided biopsy to obtain confirmation of malignancy can be inputted. The pathology report can be uploaded to the eCRF (arrow).

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