OBJECTIVES: To assess whether vessel morphology depicted by three-dimensional (3D) power Doppler ultrasound improves discrimination between benignity and malignancy if used as a second-stage test in adnexal masses that are difficult to classify. METHODS: This was a prospective observational international multicenter diagnostic accuracy study. Consecutive patients with an adnexal mass underwent standardized transvaginal two-dimensional (2D) grayscale and color or power Doppler and 3D power Doppler ultrasound examination by an experienced examiner, and those with a 'difficult' tumor were included in the current analysis. A difficult tumor was defined as one in which the International Ovarian Tumor Analysis (IOTA) logistic regression model-1 (LR-1) yielded an ambiguous result (risk of malignancy, 8.3% to 25.5%), or as one in which the ultrasound examiner was uncertain regarding classification as benign or malignant when using subjective assessment. Even when the ultrasound examiner was uncertain, he/she was obliged to classify the tumor as most probably benign or most probably malignant. For each difficult tumor, one researcher created a 360° rotating 3D power Doppler image of the vessel tree in the whole tumor and another of the vessel tree in a 5-cm3 spherical volume selected from the most vascularized part of the tumor. Two other researchers, blinded to the patient's history, 2D ultrasound findings and histological diagnosis, independently described the vessel tree using predetermined vessel features. Their agreed classification was used. The reference standard was the histological diagnosis of the mass. The sensitivity of each test for discriminating between benign and malignant difficult tumors was plotted against 1 - specificity on a receiver-operating-characteristics diagram, and the test with the point furthest from the reference line was considered to have the best diagnostic ability. RESULTS: Of 2403 women with an adnexal mass, 376 (16%) had a difficult mass. Ultrasound volumes were available for 138 of these cases. In 79/138 masses, the ultrasound examiner was uncertain about the diagnosis based on subjective assessment, in 87/138, IOTA LR-1 yielded an ambiguous result and, in 28/138, both methods gave an uncertain result. Of the masses, 38/138 (28%) were malignant. Among tumors that were difficult to classify as benign or malignant by subjective assessment, the vessel feature 'densely packed vessels' had the best discriminative ability (sensitivity 67% (18/27), specificity 83% (43/52)) and was slightly superior to subjective assessment (sensitivity 74% (20/27), specificity 60% (31/52)). In tumors in which IOTA LR-1 yielded an ambiguous result, subjective assessment (sensitivity 82% (14/17), specificity 79% (55/70)) was superior to the best vascular feature, i.e. changes in the diameter of vessels in the whole tumor volume (sensitivity 71% (12/17), specificity 69% (48/70)). CONCLUSION: Vessel morphology depicted by 3D power Doppler ultrasound may slightly improve discrimination between benign and malignant adnexal tumors that are difficult to classify by subjective ultrasound assessment. For tumors in which the IOTA LR-1 model yields an ambiguous result, subjective assessment is superior to vessel morphology as a second-stage test. © 2020 The Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of International Society of Ultrasound in Obstetrics and Gynecology.

1st Department of Gynecological Oncology and Gynecology Medical University of Lublin Lublin Poland

Department of Clinical Science and Education Karolinska Institute Södersjukhuset Stockholm Sweden

Department of Clinical Sciences Malmö Lund University Malmö Sweden

Department of Development and Regeneration KU Leuven Leuven Belgium

Department of Gynecological Oncology Catholic University of the Sacred Heart Rome Italy

Department of Obstetrics and Gynecology 1st Faculty of Medicine Charles University and 1st Faculty of Medicine Prague Czech Republic

Department of Obstetrics and Gynecology and Leuven Cancer Institute University Hospitals Leuven Leuven Belgium

Department of Obstetrics and Gynecology Ikazia Hospital Rotterdam Rotterdam The Netherlands

Department of Obstetrics and Gynecology San Gerardo Hospital University of Milan Bicocca Monza Italy

Department of Obstetrics and Gynecology Skåne University Hospital Malmö Sweden

Department of Obstetrics and Gynecology University of Cagliari Policlinico Universitario Duilio Casula Monserrato Cagliari Italy

Department of Obstetrics and Gynecology Ziekenhuis Oost Limburg Genk Belgium

Department of Obstetrics Gynecology and Reproduction Hospital Universitari Dexeus Barcelona Spain

Gynecology and Reproductive Medicine Unit S Orsola Malpighi Hospital University of Bologna Bologna Italy

Jules Bordet Institute Université Libre de Bruxelles Brussels Belgium

Preventive Gynecology Unit Division of Gynecology European Institute of Oncology Milan Italy

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