Numerous issues must be addressed when developing standard operating procedures for clinical research studies involving chest computed tomography of lung disease in patients with cystic fibrosis (CF). Study success depends on the provision of adequate funding and the identification of personnel with the necessary expertise to conduct the study, along with clear guidelines that detail the CT operating procedure at each site, including breathing maneuvers, and image reconstruction. Close coordination of the quality assurance process between sites and the central review organization is required to maintain protocol adherence. The data transfer process must ensure the integrity and security of the data to comply with patient privacy regulations, and study outcome measures are best assessed with a scoring system or other structured method of imaging data analysis. The recommendations provided are designed to serve as a valuable reference guide for planning clinical research studies of patients with CF involving chest CT.

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Keywords Clinical trial, Cystic fibrosis, Lung, Standardization, X-ray computed tomography
Persistent URL dx.doi.org/10.1016/j.jcf.2019.09.001, hdl.handle.net/1765/119716
Journal Journal of Cystic Fibrosis
Citation
van Straten, M, Brody, A.S, Ernst, C. (Caroline), Guillerman, R.P, Tiddens, H.A.W.M, & Nagle, S.K. (Scott K.). (2019). Guidance for computed tomography (CT) imaging of the lungs for patients with cystic fibrosis (CF) in research studies. Journal of Cystic Fibrosis. doi:10.1016/j.jcf.2019.09.001