A new computer-aided diagnostic tool for non-invasive characterisation of malignant ovarian masses: results of a multicentre validation study

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Lucidarme, O. | Akakpo, J. P. | Granberg, S. | Sideri, M. | Levavi, H. | Schneider, A. | Autier, P. | Nir, D. | Bleiberg, H. | Ovarian Histoscanning Clinical Study, Group

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Lucidarme, Olivier Akakpo, Jean-Paul Granberg, Seth Sideri, Mario Levavi, Hanoch Schneider, Achim Autier, Philippe Nir, Dror Bleiberg, Harry eng Evaluation Studies Multicenter Study Validation Studies Germany 2010/03/23 06:00 Eur Radiol. 2010 Aug;20(8):1822-30. doi: 10.1007/s00330-010-1750-6. Epub 2010 Mar 20.. International audience. OBJECTIVES: To prospectively assess an innovative computer-aided diagnostic technology that quantifies characteristic features of backscattered ultrasound and theoretically allows transvaginal sonography (TVS) to discriminate benign from malignant adnexal masses. METHODS: Women (n = 264) scheduled for surgical removal of at least one ovary in five centres were included. Preoperative three-dimensional (3D)-TVS was performed and the voxel data were analysed by the new technology. The findings at 3D-TVS, serum CA125 levels and the TVS-based diagnosis were compared with histology. Cancer was deemed present when invasive or borderline cancerous processes were observed histologically. RESULTS: Among 375 removed ovaries, 141 cancers (83 adenocarcinomas, 24 borderline, 16 cases of carcinomatosis, nine of metastases and nine others) and 234 non-cancerous ovaries (107 normal, 127 benign tumours) were histologically diagnosed. The new computer-aided technology correctly identified 138/141 malignant lesions and 206/234 non-malignant tissues (98% sensitivity, 88% specificity). There were no false-negative results among the 47 FIGO stage I/II ovarian lesions. Standard TVS and CA125 had sensitivities/specificities of 94%/66% and 89%/75%, respectively. Combining standard TVS and the new technology in parallel significantly improved TVS specificity from 66% to 92% (p < 0.0001). CONCLUSIONS: Computer-aided quantification of backscattered ultrasound is a highly sensitive for the diagnosis of malignant ovarian masses.

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