S. Timmerman

Validation of ADNEX and IOTA two‐step strategy and estimation of risk of complications during follow‐up of adnexal masses in low‐risk population

ABSTRACTObjectivesTo evaluate the ability of the Assessment of Different NEoplasias in the adneXa (ADNEX) model and the International Ovarian Tumour Analysis (IOTA) two‐step strategy to predict malignancy in adnexal masses detected in an outpatient low‐risk setting, and to estimate the risk of complications in masses with benign ultrasound morphology managed using clinical and ultrasound follow‐up.MethodsThis single‐center study was performed at Hospital Universitari Dexeus, Barcelona, Spain, using interim data from the ongoing prospective observational IOTA Phase‐5 (IOTA5) study. The primary aim of the IOTA5 study is to describe the cumulative incidence of complications during follow‐up of adnexal masses classified as benign on ultrasound examination. Consecutive patients with an adnexal mass detected between June 2012 and September 2016 in a private center offering screening for gynecological cancer were included and followed up until February 2020. Tumors were classified as benign or malignant based on histology (if patients underwent surgery) or the outcome of clinical and ultrasound follow‐up at 12 (range, 10–14) months. Multiple imputation was used when outcomes were uncertain. The ability of the ADNEX model without CA125 and of the IOTA two‐step strategy to distinguish benign from malignant masses was evaluated retrospectively using the prospectively collected data. We assessed performance with regard to discrimination (area under the receiver‐operating‐characteristics curve (AUC)), calibration, classification (sensitivity and specificity) and clinical utility (Net Benefit). In the group of patients with a mass judged to be benign who were selected for conservative management, we evaluated the occurrence of spontaneous resolution or any mass complication during the first 5 years of follow‐up by assessing the cumulative incidence of malignancy, torsion, cyst rupture and minor mass complications (inflammation, infection or adhesions) and the time to occurrence of an event.ResultsA total of 2654 patients were recruited to the study. After application of exclusion criteria, 2039 patients with a newly detected mass were included for the model validation. Of those, 1684 (83%) masses were benign, 49 (2%) masses were malignant and, for 306 (15%) masses, the outcome was uncertain and therefore imputed. The AUC was 0.95 (95% CI, 0.89–0.98) for ADNEX without CA125 and 0.94 (95% CI, 0.88–0.97) for the two‐step strategy. Calibration performance could not be meaningfully interpreted because the small number of malignancies resulted in very wide confidence intervals. The two‐step strategy had better clinical utility than did the ADNEX model at malignancy risk thresholds < 3%. There were 1472 (72%) patients whose mass was judged to be benign based on pattern recognition by an experienced ultrasound examiner and were managed with clinical and ultrasound follow‐up. In this group, the 5‐year cumulative incidence was 66% (95% CI, 63–69%) for spontaneous resolution of the mass, 0% (95% CI, 0–0.2%) for torsion, 0.1% (95% CI, < 0.1–0.4%) for cyst rupture, 0.2% (95% CI, 0.1–0.6%) for a borderline tumor and 0.2% (95% CI, 0.1–0.6%) for invasive malignancy.ConclusionsThe ADNEX model and IOTA two‐step strategy performed well to distinguish benign from malignant adnexal masses detected in a low‐risk population. Conservative management is safe for masses with a benign ultrasound appearance in this population. © 2024 International Society of Ultrasound in Obstetrics and Gynecology.

Imaging in gynecological disease (24): clinical and ultrasound characteristics of ovarian mature cystic teratomas

ABSTRACTObjectiveTo describe the clinical and ultrasound features of ovarian mature cystic teratomas (MCTs).MethodsThis was a retrospective study. From the International Ovarian Tumor Analysis (IOTA) database, we identified patients with a histologically confirmed diagnosis of MCT who had undergone transvaginal ultrasound examination between 1999 and 2016 (IOTA phases 1, 2, 3 and 5) in one of five centers. Ultrasound was performed by an experienced examiner who used the standardized IOTA examination technique and terminology. In addition to extracting data from the IOTA database, available two‐dimensional grayscale and color or power Doppler images were reviewed retrospectively to identify typical ultrasound features of MCT described previously and detect possible new features using pattern recognition. All images were reviewed by two independent examiners and further discussed with two ultrasound experts to reach consensus.ResultsIncluded in the study were 454 patients with histologically confirmed MCT. Median age was 33 (range, 8–90)  years and 66 (14.5%) patients were postmenopausal. Most MCTs were described by the original ultrasound examiner as unilocular (262/454 (57.7%)) or multilocular (70/454 (15.4%)) cysts with mixed echogenicity of cystic fluid (368/454 (81.1%)), acoustic shadowing (328/454 (72.2%)) and no or little vascularization on color Doppler (color score 1, 240/454 (52.9%); color score 2, 123/454 (27.1%)). The median largest lesion diameter was 66 (range, 15–310)  mm. A correct preoperative diagnosis of MCT was suggested by the original ultrasound examiner in 372/454 (81.9%) cases. On retrospective review of ultrasound images of 334 MCTs that had quality sufficient for assessment, ‘dots and/or lines’ and/or ‘echogenic white ball’ (typical features according to the literature) were present in 271/334 (81.1%) masses. We identified four new ultrasound features characteristic of MCT: ‘cotton wool tufts’, ‘mushroom cap sign’, ‘completely hyperechogenic lesion’ and ‘starry sky sign’. At least one classical or novel ultrasound feature was present in 315/334 (94.3%) MCTs. Twenty‐nine (8.7%) MCTs manifested vascularized solid tissue, of which seven exhibited no typical features.ConclusionWe provide a comprehensive overview of conventional and newly described ultrasound features of MCTs. Only a small proportion of MCTs did not manifest any of the typical features. © 2022 International Society of Ultrasound in Obstetrics and Gynecology.

ISUOG/ESGO Consensus Statement on ultrasound‐guided biopsy in gynecological oncology

ABSTRACTThe International Society of Ultrasound in Obstetrics and Gynecology (ISUOG) with the European Society of Gynaecological Oncology (ESGO) jointly developed clinically relevant and evidence‐based statements on performing ultrasound‐guided biopsies in gynecological oncology.The objective of this Consensus Statement is to assist clinicians, including gynecological sonographers, gynecological oncologists and radiologists, to achieve the best standards of practice in ultrasound‐guided biopsy procedures. ISUOG/ESGO nominated a multidisciplinary international group of 16 experts who have demonstrated leadership in the use of ultrasound‐guided biopsy in the clinical management of patients with gynecological cancer. In addition, two early‐career gynecological fellows were nominated to participate from the European Network of Young Gynae Oncologists (ENYGO) within ESGO and from ISUOG. The group also included a patient representative from the European Network of Gynaecological Cancer Advocacy Groups. The document is divided into six sections: (1) general recommendations; (2) image‐guided biopsy (imaging guidance, sampling methods); (3) indications and contraindications; (4) technique; (5) reporting; and (6) training and quality assurance. To ensure that the statements are evidence‐based, the current literature was reviewed and critically appraised. Preliminary statements were drafted based on this review of the literature. During a conference call, the whole group discussed each preliminary statement, and a first round of voting was carried out. The group achieved consensus on all 46 preliminary statements without the need for revision.These ISUOG/ESGO statements on ultrasound‐guided biopsy in gynecological oncology, together with a summary of the evidence supporting each statement, are presented herein. This Consensus Statement is supplemented by detailed narrated videoclips presenting different approaches and indications for ultrasound‐guided biopsy, a patient leaflet, and an extended version which includes a detailed review of the evidence. © 2025 The Authors. Published by John Wiley & Sons Ltd on behalf of The International Society of Ultrasound in Obstetrics and Gynecology (ISUOG) and by Elsevier Inc. on behalf of the European Society of Gynaecological Oncology and the International Gynecologic Cancer Society.

Ultrasound features using MUSA terms and definitions in uterine sarcoma and leiomyoma: cohort study

ABSTRACTObjectivesTimely and accurate preoperative diagnosis of uterine sarcoma will increase patient survival. The primary aim of this study was to describe the ultrasound features of uterine sarcoma compared with those of uterine leiomyoma based on the terms and definitions of the Morphological Uterus Sonographic Assessment (MUSA) group. A secondary aim was to assess the interobserver agreement for reporting on ultrasound features according to MUSA terminology.MethodsThis was a retrospective cohort study of patients with uterine sarcoma or uterine leiomyoma treated in a single tertiary center during the periods 1997–2019 and 2016–2019, respectively. Demographic characteristics, presenting symptoms and surgical outcomes were extracted from patients' files. Ultrasound images were re‐evaluated independently by two sonologists using MUSA terms and definitions. Descriptive statistics were calculated and interobserver agreement was assessed using Cohen's κ (with squared weights) or intraclass correlation coefficient, as appropriate.ResultsA total of 107 patients were included, of whom 16 had a uterine sarcoma and 91 had a uterine leiomyoma. Abnormal uterine bleeding was the most frequent presenting symptom (69/107 (64%)). Compared with leiomyoma cases, patients with uterine sarcoma were older (median age, 65 (interquartile range (IQR), 60–70) years vs 48 (IQR, 43–52) years) and more likely to be postmenopausal (13/16 (81%) vs 15/91 (16%)). In the uterine sarcoma cohort, leiomyosarcoma was the most frequent histological type (6/16 (38%)), followed by adenosarcoma (4/16 (25%)). On ultrasound evaluation, according to Observers 1 and 2, the tumor border was irregular in most sarcomas (11/16 (69%) and 13/16 (81%) cases, respectively), but regular in most leiomyomas (65/91 (71%) and 82/91 (90%) cases, respectively). Lesion echogenicity was classified as non‐uniform in 68/91 (75%) and 51/91 (56%) leiomyomas by Observers 1 and 2, respectively, and 15/16 (94%) uterine sarcomas by both observers. More than 60% of the uterine sarcomas showed acoustic shadows (11/16 (69%) and 10/16 (63%) cases by Observers 1 and 2, respectively), whereas calcifications were reported in a small minority (0/16 (0%) and 2/16 (13%) cases by Observers 1 and 2, respectively). In uterine sarcomas, intralesional vascularity was reported as moderate to abundant in 13/16 (81%) cases by Observer 1 and 15/16 (94%) cases by Observer 2, while circumferential vascularity was scored as moderate to abundant in 6/16 (38%) by both observers. Interobserver agreement for the presence of cystic areas, calcifications, acoustic shadow, central necrosis, color score (overall, intralesional and circumferential) and maximum diameter of the lesion was moderate. The agreement for shape of lesion, tumor border and echogenicity was fair.ConclusionsA postmenopausal patient presenting with abnormal uterine bleeding and a new or growing mesenchymal mass with irregular tumor borders, moderate‐to‐abundant intralesional vascularity, cystic areas and an absence of calcifications on ultrasonography is at a higher risk of having a uterine sarcoma. Interobserver agreement for most MUSA terms and definitions is moderate. Future studies should validate the abovementioned clinical and ultrasound findings on uterine mesenchymal tumors in a prospective multicenter fashion. © 2023 International Society of Ultrasound in Obstetrics and Gynecology.

International Ovarian Tumour Analysis (IOTA) Phase 5

The purpose of this study is to learn more about the appearance and behavior of benign-looking adnexal masses. * Benign-looking means that when viewed here by ultrasound it has the appearance of looking not harmful or not malignant. * Adnexal refers to the 'adnexa', the space in the female pelvis on either side of the uterus (or where the uterus used to be if you previously had a hysterectomy). The adnexa includes, but is not limited to, the ovaries and the fallopian tubes. * Masses refers to a variety of structures, including but not limited to: * ovarian cysts that are fluid filled sacs within or attached to an ovary * ovarian tumors that can be solid tissue or a combination of cysts and solid tissue * hydrosalpinges that are fluid collections in the fallopian tube Many women have what appear to be benign adnexal masses. Many times, removal of the masses with surgery is not necessary. Often surgery is performed unnecessarily, for fear that these masses could be cancer. There is not much information available for doctors to know how and when to follow these masses, or which ones will become cancer. This study will combine information from centers all around the world regarding the behavior of all types of benign adnexal masses. The aim of this study is to develop decision tools for doctors to know the best way to treat these masses in order to improve the detection of ovarian cancer while at the same time reduce the number of unnecessary operations.