Caroline Reinhold, Ingrid Millet, Teresa Margarida Cunha, Valérie Juhan, Gabriele Masselli, Sanja Stojanovic, Aurélie Jalaguier-Coudray, Elizabeth A. Sadowski, Raphaël Porcher, Emile Daraï, Marc Bazot, Caroline Malhaire, Andrea Rockall, Patrice Taourel, Laure Fournier, Nishat Bharwani, Nicolas Perrot, Adalgisa Guerra, Corinne Balleyguier, E. Poncelet, Isabelle Thomassin-Naggara, Service de Radiologie [CHU Tenon], Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-CHU Tenon [APHP], Sorbonne Université (SU), Centre hospitalier [Valenciennes, Nord], Institut Paoli-Calmettes, Fédération nationale des Centres de lutte contre le Cancer (FNCLCC), Hôpital Européen Georges Pompidou [APHP] (HEGP), Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO), Université Paris Descartes - Paris 5 (UPD5), University of Novi Sad, Hôpital Lapeyronie [Montpellier] (CHU), Université de Montpellier (UM), Imperial College London, Hôpital de la Timone [CHU - APHM] (TIMONE), Sapienza University [Rome], Institut Gustave Roussy (IGR), Institut Curie, University of Wisconsin-Madison, Centre de Recherche Épidémiologie et Statistique Sorbonne Paris Cité (CRESS (U1153 / UMR_A_1125 / UMR_S_1153)), Institut National de la Recherche Agronomique (INRA)-Université Paris Diderot - Paris 7 (UPD7)-Université Paris Descartes - Paris 5 (UPD5)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM), Université Sorbonne Paris Cité (USPC), Service Gynécologie-Obstétrique et Médecine de la reproduction [Hôpital Tenon], Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-Sorbonne Université (SU), McGill University Health Center [Montreal] (MUHC), Imperial College Healthcare NHS Trust- BRC Funding, Cancer Research UK, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-CHU Tenon [AP-HP], Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO), Università degli Studi di Roma 'La Sapienza' = Sapienza University [Rome], Institut Curie [Paris], Conservatoire National des Arts et Métiers [CNAM] (CNAM)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Paris (UP)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), Gynécologie-obstétrique et médecine de la reproduction - Maternité [CHU Tenon], CHU Tenon [AP-HP], Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), and Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO)-Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)
International audience; Importance: Approximately one-quarter of adnexal masses detected at ultrasonography are indeterminate for benignity or malignancy, posing a substantial clinical dilemma.Objective: To validate the accuracy of a 5-point Ovarian-Adnexal Reporting Data System Magnetic Resonance Imaging (O-RADS MRI) score for risk stratification of adnexal masses.Design, setting, and participants: This multicenter cohort study was conducted between March 1, 2013, and March 31, 2016. Among patients undergoing expectant management, 2-year follow-up data were completed by March 31, 2018. A routine pelvic MRI was performed among consecutive patients referred to characterize a sonographically indeterminate adnexal mass according to routine diagnostic practice at 15 referral centers. The MRI score was prospectively applied by 2 onsite readers and by 1 reader masked to clinical and ultrasonographic data. Data analysis was conducted between April and November 2018.Main outcomes and measures: The primary end point was the joint analysis of true-negative and false-negative rates according to the MRI score compared with the reference standard (ie, histology or 2-year follow-up).Results: A total of 1340 women (mean [range] age, 49 [18-96] years) were enrolled. Of 1194 evaluable women, 1130 (94.6%) had a pelvic mass on MRI with a reference standard (surgery, 768 [67.9%]; 2-year follow-up, 362 [32.1%]). A total of 203 patients (18.0%) had at least 1 malignant adnexal or nonadnexal pelvic mass. No invasive cancer was assigned a score of 2. Positive likelihood ratios were 0.01 for score 2, 0.27 for score 3, 4.42 for score 4, and 38.81 for score 5. Area under the receiver operating characteristic curve was 0.961 (95% CI, 0.948-0.971) among experienced readers, with a sensitivity of 0.93 (95% CI, 0.89-0.96; 189 of 203 patients) and a specificity of 0.91 (95% CI, 0.89-0.93; 848 of 927 patients). There was good interrater agreement among both experienced and junior readers (κ = 0.784; 95% CI, 0.743-0824). Of 580 of 1130 women (51.3%) with a mass on MRI and no specific gynecological symptoms, 362 (62.4%) underwent surgery. Of them, 244 (67.4%) had benign lesions and a score of 3 or less. The MRI score correctly reclassified the mass origin as nonadnexal with a sensitivity of 0.99 (95% CI, 0.98-0.99; 1360 of 1372 patients) and a specificity of 0.78 (95% CI, 0.71-0.85; 102 of 130 patients).Conclusions and relevance: In this study, the O-RADS MRI score was accurate when stratifying the risk of malignancy in adnexal masses.