TY - JOUR
T1 - Diagnostic Accuracy of a Convolutional Neural Network Assessment of Solitary Pulmonary Nodules Compared With PET With CT Imaging and Dynamic Contrast-Enhanced CT Imaging Using Unenhanced and Contrast-Enhanced CT Imaging
AU - SPUtNIk investigators
AU - Weir-McCall, Jonathan R.
AU - Debruyn, Elise
AU - Harris, Scott
AU - Qureshi, Nagmi R.
AU - Rintoul, Robert C.
AU - Gleeson, Fergus V.
AU - Gilbert, Fiona J.
AU - Lucy Brindle, Anindo Banerjee
AU - Callister, Matthew
AU - Clegg, Andrew
AU - Cook, Andrew
AU - Cozens, Kelly
AU - Crosbie, Philip
AU - Dizdarevic, Sabina
AU - Eaton, Rosemary
AU - Eichhorst, Kathrin
AU - Frew, Anthony
AU - Groves, Ashley
AU - Han, Sai
AU - Jones, Jeremy
AU - Kankam, Osie
AU - Karunasaagarar, Kavitasagary
AU - Kurban, Lutfi
AU - Little, Louisa
AU - Madden, Jackie
AU - McClement, Chris
AU - Miles, Ken
AU - Moate, Patricia
AU - Peebles, Charles
AU - Pike, Lucy
AU - Poon, Fat Wui
AU - Sinclair, Donald
AU - Shah, Andrew
AU - Vale, Luke
AU - George, Steve
AU - Riley, Richard
AU - Lodge, Andrea
AU - Buscombe, John
AU - Green, Theresa
AU - Stone, Amanda
AU - Navani, Neal
AU - Shortman, Robert
AU - Azzopardi, Gabriella
AU - Doffman, Sarah
AU - Bush, Janice
AU - Lyttle, Jane
AU - Jacob, Kenneth
AU - Horst, Joris van der
AU - Sarvesvaran, Joseph
AU - Smith, Elaine
N1 - Funding Information:
Author contributions: J. R. W.-M. was involved in the design of the study, delivery of the study, interpretation of the results, and writing of the report. F. J. G. was involved in the design of the study, delivery of the study, interpretation of the results, and writing of the report. S. H. was involved in the design of the study, delivery of the study, statistical analysis, interpretation of the results, and writing of the report. E. D. was involved in the delivery of the study and interpretation of the results. N. R. Q. was involved in the design of the study, delivery of the study, and interpretation of the results. R. C. R. was involved in the design of the study, delivery of the study, and interpretation of the results. F. V. G. was involved in the design of the study and was responsible for recruiting participants. All authors reviewed the final report. Role of sponsors: The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care. Beyond the provision of and training in the software, no Optellum employees were involved the study's design, conduct, data analysis or interpretation. ∗ SPUtNIk Investigators: Anindo Banerjee, Lucy Brindle, Matthew Callister, Andrew Clegg, Andrew Cook, Kelly Cozens, Philip Crosbie, Sabina Dizdarevic, Rosemary Eaton, Kathrin Eichhorst, Anthony Frew, Ashley Groves, Sai Han, Jeremy Jones, Osie Kankam, Kavitasagary Karunasaagarar, Lutfi Kurban, Louisa Little, Jackie Madden, Chris McClement, Ken Miles, Patricia Moate, Charles Peebles, Lucy Pike, Fat-Wui Poon, Donald Sinclair, Andrew Shah, Luke Vale, Steve George, Richard Riley, Andrea Lodge, John Buscombe, Theresa Green, Amanda Stone, Neal Navani, Robert Shortman, Gabriella Azzopardi, Sarah Doffman, Janice Bush, Jane Lyttle, Kenneth Jacob, Joris van der Horst, Joseph Sarvesvaran, Barbara McLaren, Lesley Gomersall, Ravi Sharma, Kathleen Collie, Steve O'Hickey, Jayne Tyler, Sue King, John O'Brien, Rajiv Srivastava, Hugh Lloyd-Jones, Sandra Beech, Andrew Scarsbrook, Victoria Ashford-Turner, Elaine Smith, Susan Mbale, Nick Adams, and Gail Pottinger. Data sharing: Individual participant data from the SPUtNIk trial will be made available, including data dictionaries, for approved data sharing requests. Individual participant data will be shared that underlie the results reported in this article, after de-identification and normalization of information (text, tables, figures, and appendixes). The study protocol and statistical analysis plan also will be available. Anonymous data will be available for request from 3 months after publication of the article to researchers who provide a completed data sharing request form that describes a methodologically sound proposal for the purpose of the approved proposal and, if appropriate, have signed a data sharing agreement. Data will be shared after all parties have signed relevant data sharing documentation, covering Southampton Clinical Trials Unit conditions for sharing and, if required, an additional data sharing agreement from the sponsor. Proposals should be directed to [email protected]. Additional information: The e-Figures and e-Table are available online under “Supplementary Data.”
Funding Information:
The trial was funded by the National Institute for Health and Care Research Health Technology Assessment Program [Grant 09/22/117] and is being run by Southampton Clinical Trials Unit, which is funded in part by Cancer Research United Kingdom. F. J. G. is an NIHR Senior Investigator. R. C. R. is funded in part by the NIHR Cambridge Biomedical Research Centre, Cancer Research UK Cambridge Centre [Grant BRC-1215-20014], and the Cancer Research Network: Eastern. N. R. Q. is funded in part by the Cambridge Biomedical Research Centre. This research was supported by the NIHR Cambridge Biomedical Research Centre [Grant BRC-1215-20014]. Access to software to generate LCP-CNN scores was provided by Optellum Ltd.
Publisher Copyright:
© 2022 American College of Chest Physicians
PY - 2023/2/1
Y1 - 2023/2/1
N2 - Background: Solitary pulmonary nodules (SPNs) measuring 8 to 30 mm in diameter require further workup to determine the likelihood of malignancy. Research Question: What is the diagnostic performance of a lung cancer prediction convolutional neural network (LCP-CNN) in SPNs using unenhanced and contrast-enhanced CT imaging compared with the current clinical workup? Study Design and Methods: This was a post hoc analysis of the Single Pulmonary Nodule Investigation: Accuracy and Cost-Effectiveness of Dynamic Contrast Enhanced Computed Tomography in the Characterisation of Solitary Pulmonary Nodules trial, a prospective multicenter study comparing the diagnostic accuracy of dynamic contrast-enhanced (DCE) CT imaging with PET imaging in SPNs. The LCP-CNN was designed and validated in an external cohort. LCP-CNN-generated risk scores were created from the noncontrast and contrast-enhanced CT scan images from the DCE CT imaging. The gold standard was histologic analysis or 2 years of follow-up. The area under the receiver operating characteristic curves (AUC) were calculated using LCP-CNN score, maximum standardized uptake value, and DCE CT scan maximum enhancement and were compared using the DeLong test. Results: Two hundred seventy participants (mean ± SD age, 68.3 ± 8.8 years; 49% women) underwent PET with CT scan imaging and DCE CT imaging with CT scan data available centrally for LCP-CNN analysis. The accuracy of the LCP-CNN on the noncontrast images (AUC, 0.83; 95% CI, 0.79-0.88) was superior to that of DCE CT imaging (AUC, 0.76; 95% CI, 0.69-0.82; P = .03) and equal to that of PET with CT scan imaging (AUC, 0.86; 95% CI, 0.81-0.90; P = .35). The presence of contrast resulted in a small reduction in diagnostic accuracy, with the AUC falling from 0.83 (95% CI, 0.79-0.88) on the noncontrast images to 0.80 to 0.83 after contrast (P < .05 for 240 s after contrast only). Interpretation: An LCP-CNN algorithm provides an AUC equivalent to PET with CT scan imaging in the diagnosis of solitary pulmonary nodules. Trial Registration: ClinicalTrials.gov Identifier; No.: NCT02013063
AB - Background: Solitary pulmonary nodules (SPNs) measuring 8 to 30 mm in diameter require further workup to determine the likelihood of malignancy. Research Question: What is the diagnostic performance of a lung cancer prediction convolutional neural network (LCP-CNN) in SPNs using unenhanced and contrast-enhanced CT imaging compared with the current clinical workup? Study Design and Methods: This was a post hoc analysis of the Single Pulmonary Nodule Investigation: Accuracy and Cost-Effectiveness of Dynamic Contrast Enhanced Computed Tomography in the Characterisation of Solitary Pulmonary Nodules trial, a prospective multicenter study comparing the diagnostic accuracy of dynamic contrast-enhanced (DCE) CT imaging with PET imaging in SPNs. The LCP-CNN was designed and validated in an external cohort. LCP-CNN-generated risk scores were created from the noncontrast and contrast-enhanced CT scan images from the DCE CT imaging. The gold standard was histologic analysis or 2 years of follow-up. The area under the receiver operating characteristic curves (AUC) were calculated using LCP-CNN score, maximum standardized uptake value, and DCE CT scan maximum enhancement and were compared using the DeLong test. Results: Two hundred seventy participants (mean ± SD age, 68.3 ± 8.8 years; 49% women) underwent PET with CT scan imaging and DCE CT imaging with CT scan data available centrally for LCP-CNN analysis. The accuracy of the LCP-CNN on the noncontrast images (AUC, 0.83; 95% CI, 0.79-0.88) was superior to that of DCE CT imaging (AUC, 0.76; 95% CI, 0.69-0.82; P = .03) and equal to that of PET with CT scan imaging (AUC, 0.86; 95% CI, 0.81-0.90; P = .35). The presence of contrast resulted in a small reduction in diagnostic accuracy, with the AUC falling from 0.83 (95% CI, 0.79-0.88) on the noncontrast images to 0.80 to 0.83 after contrast (P < .05 for 240 s after contrast only). Interpretation: An LCP-CNN algorithm provides an AUC equivalent to PET with CT scan imaging in the diagnosis of solitary pulmonary nodules. Trial Registration: ClinicalTrials.gov Identifier; No.: NCT02013063
KW - diagnostic test accuracy
KW - machine learning
KW - positron emission tomography computed tomography
KW - solitary pulmonary nodule
KW - tomography
KW - X-ray computed
U2 - 10.1016/j.chest.2022.08.2227
DO - 10.1016/j.chest.2022.08.2227
M3 - Article
C2 - 36087795
AN - SCOPUS:85146129097
SN - 0012-3692
VL - 163
SP - 444
EP - 454
JO - Chest
JF - Chest
IS - 2
ER -