Integrating clinical research in an operative screening and diagnostic breast imaging department: First experience, results and perspectives using microwave imaging.
Journal article
Álvarez Sánchez-Bayuela, D., Giovanetti González, R., Aguilar Angulo, P.M., Cruz Hernández, L.M., Sánchez-Camacho González-Carrato, M.D.P., Rodríguez Sánchez, A., Tiberi, G. and Romero Castellano, C. (2023). Integrating clinical research in an operative screening and diagnostic breast imaging department: First experience, results and perspectives using microwave imaging. Heliyon. 9 (11), p. e21904. https://doi.org/10.1016/j.heliyon.2023.e21904
Authors | Álvarez Sánchez-Bayuela, D., Giovanetti González, R., Aguilar Angulo, P.M., Cruz Hernández, L.M., Sánchez-Camacho González-Carrato, M.D.P., Rodríguez Sánchez, A., Tiberi, G. and Romero Castellano, C. |
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Abstract | Clinical research is crucial for evaluating new medical procedures and devices. It is important for healthcare units and hospitals to minimize the disruptions caused by conducting clinical studies; however, complex clinical pathways require dedicated recruitment and study designs.This work presents the effective introduction of novel microwave breast imaging (MBI), via MammoWave apparatus, into the clinical routine of an operative screening and diagnostic breast imaging department for conducting a multicentric clinical study. Microwave breast imaging, using MammoWave apparatus, was performed on volunteers coming from different clinical pathways. Clinical data, comprising demographics and conventional radiologic reports (used as reference standard), was collected; a satisfaction questionnaire was filled by every volunteer. Microwave images were analyzed by an automatic clinical decision support system, which quantified their corresponding features to discriminate between breasts with no relevant radiological findings (NF) and breasts with described findings (WF). Conventional breast imaging (DBT, US, MRI) and MBI were performed and adapted to assure best clinical practices and optimum pathways. 180 volunteers, both symptomatic and asymptomatic, were enrolled in the study. After microwave images' quality assessment, 48 NF (15 dense) and 169 WF (88 dense) breasts were used for the prospective study; 48 (18 dense) breasts suffered from a histology-confirmed carcinoma. An overall sensitivity of 85.8 % in breasts lesions' detection was achieved by the microwave imaging apparatus. An optimum recruitment strategy was implemented to assess MBI. Future trials may show the clinical usefulness of microwave imaging, which may play an important role in breast screening. [Abstract copyright: © 2023 The Authors.] |
Keywords | Breast imaging research; Microwave imaging; Microwave breast imaging; Breast lesions; Breast cancer |
Year | 2023 |
Journal | Heliyon |
Journal citation | 9 (11), p. e21904 |
Publisher | Elsevier |
ISSN | 2405-8440 |
Digital Object Identifier (DOI) | https://doi.org/10.1016/j.heliyon.2023.e21904 |
https://doi.org/S2405-8440(23)09112-0 | |
Publication dates | |
Online | 03 Nov 2023 |
Publication process dates | |
Accepted | 31 Oct 2023 |
Deposited | 29 Jan 2024 |
Publisher's version | License File Access Level Open |
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https://openresearch.lsbu.ac.uk/item/96389
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