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Simple Summary Inguinal node status represents one of the key elements in defining prognosis and treatment strategies in vulvar cancer patients. Preoperative lymph node staging is still a challenging topic. Several imaging methods are currently recommended in the guidelines (CT, PET/CT, MRI, US) based on performance data that are still not conclusive in the literature. Recently, ultrasound is emerging as the method of choice for preoperative evaluation of the inguinofemoral LN, but only when performed by experienced operators, given the limited reliability of subjective evaluation by unskilled operators. The morphonode predictive model represents an artificial intelligence tool that aims to overcome this limitation by supporting the standard ultrasound in adequately predicting the presence of lymph node metastases for improving preoperative surgical planning. We plan to proceed with further multicenter prospective validation and further develop the actual model, including both clinical and biological data. Ultrasound examination is an accurate method in the preoperative evaluation of the inguinofemoral lymph nodes when performed by experienced operators. The purpose of the study was to build a robust, multi-modular model based on machine learning to discriminate between metastatic and non-metastatic inguinal lymph nodes in patients with vulvar cancer. One hundred and twenty-seven women were selected at our center from March 2017 to April 2020, and 237 inguinal regions were analyzed (75 were metastatic and 162 were non-metastatic at histology). Ultrasound was performed before surgery by experienced examiners. Ultrasound features were defined according to previous studies and collected prospectively. Fourteen informative features were used to train and test the machine to obtain a diagnostic model (Morphonode Predictive Model). The following data classifiers were integrated: (I) random forest classifiers (RCF), (II) regression binomial model (RBM), (III) decisional tr

Research question: How do clinical rectovaginal examination and transvaginal ultrasound examination perform in the diagnosis of parametrial infiltration in patients with endometriosis? Design: This was a multicentre prospective observational study. Patients with suspected deep endometriosis at clinical examination and/or at ultrasound evaluation and scheduled for surgery were included. Following multicentre multidisciplinary meetings, consensus was obtained on terms and methodology to define the parametrium at pelvic anatomy, ultrasound and surgery. Sensitivity, specificity, accuracy, and positive and negative likelihood ratios were calculated for clinical and ultrasound examinations with respect to surgery. Results: In total, 195 women were selected for the present study and 164 were included in the analysis. Ultrasound examination had good to high specificity (>80%) for all parameters, except the left lateral parametrium (78.8%). The sensitivity of ultrasound examination was good to high for fixity of the right and left ovaries, uterosacral ligaments, retrocervix and rectovaginal space; and low for the anterior and lateral parametria, vagina, bladder and bowel. Clinical examination had good to high specificity for fixity of the left ovary, anterior parametrium, right uterosacral ligament, retrocervix and vagina; and low specificity for fixity of the right ovary, lateral parametrium, left uterosacral ligament and rectovaginal space. The sensitivity of clinical examination was good for the uterosacral ligaments and rectovaginal space, and low for the remaining parameters. Conclusion: Ultrasound examination provided good specificity for all the parameters, but sensitivity was low for the anterior and lateral parametria. Clinical examination provided good specificity for the anterior and posterior parametria, but sensitivity was low for the anterior and lateral parametria. Further prospective studies are needed to validate this methodology and confirm the results.

Objectives: Fusion imaging is an emerging technique that can fuse real time ultrasound examination with other imaging modalities such as computed tomography (CT), magnetic resonance, and positron emission tomography. The primary aim of the study was to evaluate the Fusion imaging feasibility in patients with advanced ovarian cancer. The secondary aims were: 1) to compare agreement laparoscopic findings with Fusion, CT scan alone and ultrasound alone in assessing the extension of intra-abdominal disease; 2) to evaluate the time required by the Fusion technique. Methods: patients with clinical and/or radiographic suspicion of advanced ovarian or peritoneal cancer and candidate to surgery were prospectively enrolled between December 2019 and September 2020. All patients underwent CT scan, ultrasound and Fusion examination in order to evaluate the presence/absence of the following abdominal cancer features according to the laparoscopy-based scoring model (PIV: Predictive Index Value): supracolic omentum disease, visceral carcinomatosis on the liver, lesser omental carcinomatosis and/or visceral carcinomatosis on the lesser curvature of stomach and/or on the spleen, parietal peritoneal involvement of paracolic gutter/-s and/or anterior abdominal wall, parietal peritoneal involvement of diaphragm and visceral carcinomatosis on small and large bowel (except rectosigmoid). Feasibility of the Fusion examination was evaluated. Agreement between each imaging method (ultrasound, CT scan and Fusion) and laparoscopy (considered as reference standard) was calculated using Cohen's kappa coefficient. Results: 52 patients were enrolled in the study. Fusion examination was feasible in 51/52 (98%) patients (in one patient the CD was not working). Two other patients were excluded because laparoscopy was not performed. 49 women were considered for final analysis. Kappa values between CT, ultrasound, Fusion and laparoscopy in assessing the PIV parameters were respectively: 0.781, 0.845 an

Objective: To develop a preoperative risk model, using endometrial biopsy results and clinical and ultrasound variables, to predict the individual risk of lymph-node metastases in women with endometrial cancer. Methods: A mixed-effects logistic regression model for prediction of lymph-node metastases was developed in 1501 prospectively included women with endometrial cancer undergoing transvaginal ultrasound examination before surgery, from 16 European centers. Missing data, including missing lymph-node status, were imputed. Discrimination, calibration and clinical utility of the model were evaluated using leave-center-out cross validation. The predictive performance of the model was compared with that of risk classification from endometrial biopsy alone (high-risk defined as endometrioid cancer Grade 3/non-endometrioid cancer) or combined endometrial biopsy and ultrasound (high-risk defined as endometrioid cancer Grade 3/non-endometrioid cancer/deep myometrial invasion/cervical stromal invasion/extrauterine spread). Results: Lymphadenectomy was performed in 691 women, of whom 127 had lymph-node metastases. The model for prediction of lymph-node metastases included the predictors age, duration of abnormal bleeding, endometrial biopsy result, tumor extension and tumor size according to ultrasound and undefined tumor with an unmeasurable endometrium. The model's area under the curve was 0.73 (95% CI, 0.68–0.78), the calibration slope was 1.06 (95% CI, 0.79–1.34) and the calibration intercept was 0.06 (95% CI, –0.15 to 0.27). Using a risk threshold for lymph-node metastases of 5% compared with 20%, the model had, respectively, a sensitivity of 98% vs 48% and specificity of 11% vs 80%. The model had higher sensitivity and specificity than did classification as high-risk, according to endometrial biopsy alone (50% vs 35% and 80% vs 77%, respectively) or combined endometrial biopsy and ultrasound (80% vs 75% and 53% vs 52%, respectively). The model's clinical utility was

Objectives: To describe the clinical and ultrasound characteristics of adnexal torsion. Methods: This was a retrospective study. From the operative records of the eight participating gynecological ultrasound centers, we identified patients with a surgically confirmed diagnosis of adnexal torsion, defined as surgical evidence of ovarian pedicle, paraovarian cyst and/or Fallopian tube twisted on its own axis, who had undergone preoperative ultrasound examination by an experienced examiner, between 2008 and 2018. Only cases with at least two available ultrasound images and/or videoclips (one grayscale and one with Doppler evaluation) were included. Clinical, ultrasound, surgical and histological information was retrieved from each patient's medical record and entered into an Excel file by the principal investigator at each center. In addition, two authors reviewed all available ultrasound images and videoclips of the twisted adnexa, with regard to the presence of four predefined ultrasound features reported to be characteristic of adnexal torsion: (1) ovarian stromal edema with or without peripherally displaced antral follicles, (2) the follicular ring sign, (3) the whirlpool sign and (4) absence of vascularization in the twisted organ. Results: A total of 315 cases of adnexal torsion were identified. The median age of the patients was 30 (range, 1–88) years. Most patients were premenopausal (284/314; 90.4%) and presented with acute or subacute pelvic pain (305/315; 96.8%). The surgical approach was laparoscopic in 239/312 (76.6%) patients and conservative surgery (untwisting with or without excision of a lesion) was performed in 149/315 (47.3%) cases. According to the original ultrasound reports, the median largest diameter of the twisted organ was 83 (range, 30–349) mm. Free fluid in the pouch of Douglas was detected in 196/275 (71.3%) patients. Ovarian stromal edema with or without peripherally displaced antral follicles was reported in the original ultrasound repor

Background: A radical surgical approach represents the mainstay treatment for gynecological malignancy, and preoperative staging of ovarian cancer is crucial. Ultrasound evaluation is widely recognized as the gold standard technique for the characterization of ovarian masses due to a high sensitivity for malignancy. In addition, its accuracy in defining intra-abdominal ovarian cancer spread has been previously proposed. Primary objective: To analyze the agreement between preoperative ultrasound examination and laparoscopic findings in assessing the extension of intra-abdominal disease using six parameters as described by Fagotti's score. Study hypothesis: When performed by expert examiners, ultrasound can be an accurate technique to assess tumor spread in ovarian cancer and therefore to predict surgical resectability. Trial design: This is a single-center prospective observational study. Patients with clinical and/or radiological suspicion of advanced ovarian or peritoneal cancer will be assessed with preoperative ultrasound and assigned a score based on the six Fagotti's laparoscopic score parameters. Each parameter will then be correlated with laparoscopic findings. Major inclusion/exclusion criteria: Eligible patients include women 18-75 years of age with clinical and/or imaging suggestive of advanced ovarian or peritoneal cancer, and an ECOG performance status 0-3. Primary endpoints: Sensitivity and specificity of ultrasound in detecting carcinomatosis, using the parameters of Fagotti's score as a reference standard. Agreement between preoperative ultrasound examination and laparoscopic findings in assessing the extension of intra-abdominal disease as described in Fagotti's score. Sample size: 240 patients. Estimate dates for completing accrual and presenting results: The accrual started in January 2019. Enrollment should be completed approximately by October 2020 and the results will be analyzed by December 2020. Trial registration: The study received the Ethic

Objective: The management of pregnant women with an adnexal tumor is still challenging and in the literature few data are available. The aim of this study was to describe the management and outcome of patients with ovarian masses detected during pregnancy. As secondary aims, we evaluated the prevalence of malignancy in the International Ovarian Tumor Analysis (IOTA) morphological classes of ovarian masses diagnosed during pregnancy, and created an algorithm for the management of patients with adnexal masses during pregnancy. Methods: This was a retrospective single centered study including patients with adnexal masses detected at any trimester during pregnancy between January 2000 and December 2019. Clinical, ultrasound, surgical, and histological data were retrieved from medical records as well as information on management (ultrasound follow-up vs surgery). Indications for surgery were recorded in terms of suspicion of malignancy based on pattern recognition of the ultrasound examiner or on symptoms or prevention of complications, such as torsion, rupture, or obstacle to normal full-term pregnancy. All masses were described using IOTA terminology. Results: A total of 113 patients were selected for the analysis. Of these, 48 (42%) patients had surveillance and 65 (58%) patients underwent surgery (11 primary ovarian tumors, one recurrence of ovarian cancer, four metastases to the ovary, 20 borderline tumors, and 29 benign lesions). Indications for surgery were suspicious malignancy in 41/65 (63.1%) cases and symptoms or prevention of complications in 24/65 (36.9%) cases. All patients in the surveillance group showed no morphological changes of the ovarian lesions at 6 months after delivery. According to the IOTA ultrasound morphological category, the prevalence of malignancy was 0% (0/37) in the unilocular cyst group, 27% (4/15) in the multilocular group, 35% (11/31) in the unilocular solid group, 70% (14/20) in the multilocular solid group, and 70% (7/10) in the sol

During the coronavirus disease 2019 (COVID‐19) outbreak, all patient categories have been affected, including one of the most fragile groups: pregnant women. Although experts provided general suggestions on the best treatment of pregnant women with suspicion of or confirmed COVID‐19, these considerations were mainly based on retrospective studies or case series.1-8 No prospective study is currently available about the treatment of patients with suspicion of or confirmed COVID‐19 during pregnancy. Moreover, no data are reported on the treatment of asymptomatic pregnant patients testing positive for COVID‐19 or pregnant patients admitted to delivery rooms.

OBJECTIVES: To compare the performance of ultrasound measurements and subjective ultrasound assessment (SA) in detecting deep myometrial invasion (MI) and cervical stromal invasion (CSI) in women with endometrial cancer, overall and according to whether they had low- or high-grade disease separately, and to validate published measurement cut-offs and prediction models to identify MI, CSI and high-risk disease (Grade-3 endometrioid or non-endometrioid cancer and/or deep MI and/or CSI). METHODS: The study comprised 1538 patients with endometrial cancer from the International Endometrial Tumor Analysis (IETA)-4 prospective multicenter study, who underwent standardized expert transvaginal ultrasound examination. SA and ultrasound measurements were used to predict deep MI and CSI. We assessed the diagnostic accuracy of the tumor/uterine anteroposterior (AP) diameter ratio for detecting deep MI and that of the distance from the lower margin of the tumor to the outer cervical os (Dist-OCO) for detecting CSI. We also validated two two-step strategies for the prediction of high-risk cancer; in the first step, biopsy-confirmed Grade-3 endometrioid or mucinous or non-endometrioid cancers were classified as high-risk cancer, while the second step encompassed the application of a mathematical model to classify the remaining tumors. The 'subjective prediction model' included biopsy grade (Grade 1 vs Grade 2) and subjective assessment of deep MI or CSI (presence or absence) as variables, while the 'objective prediction model' included biopsy grade (Grade 1 vs Grade 2) and minimal tumor-free margin. The predictive performance of the two two-step strategies was compared with that of simply classifying patients as high risk if either deep MI or CSI was suspected based on SA or if biopsy showed Grade-3 endometrioid or mucinous or non-endometrioid histotype (i.e. combining SA with biopsy grade). Histological assessment from hysterectomy was considered the reference standard. RESULTS: I

Background There are limited data on ultrasound morphologic features of gestational trophoblastic neoplasia. A predictive model to determine predictors of response to therapy would be ideal in the management of patients with this rare disease. Primary Objectives and Study Hypothesis TITANIUM is a prospective, multicenter, observational study aiming to describe ultrasound features of gestational trophoblastic neoplasia and to investigate the role of ultrasound in identifying patients at high risk of resistance to single-drug therapy. The study hypothesis is that ultrasound could improve the International Federation of Gynecology and Obstetrics (FIGO) scoring system for early identification of patients predisposed to single-drug resistance. Trial Design and Major Inclusion/Exclusion Criteria Patients eligible have a diagnosis of gestational trophoblastic neoplasia according to FIGO or the criteria set by Charing Cross Hospital, London, UK. At diagnosis, patients are classified as low-risk (score 0-6) or high-risk (score >6) according to the FIGO risk scoring system, and a baseline ultrasound scan is performed. Patients receive treatment according to local protocol at each institution. Follow-up ultrasound examinations are performed at 1, 4, 10, 16, and 22 months after start of chemotherapy, and at each scan, serum human chorionic gonadotropin (hCG) level, and chemotherapy treatment, if any, are recorded. Primary Endpoints Our aims are to define ultrasound features of gestational trophoblastic neoplasia and to develop a predictive model of resistance to single-drug therapy in low-risk patients. Sample Size The sample size was calculated assuming that 70% of patients with gestational trophoblastic neoplasia are at low risk, and estimating the rate of resistance to single-drug therapy in this group to be 40%. Assuming a dropout rate of 10%, we should recruit at least 120 patients. With this sample size, we can attempt to create a mathematical model with three variables (

INTRODUCTION: Ovarian cancer is the seventh most common cancer among women in the developed world, and most women with ovarian cancer are diagnosed at an advanced stage of disease, when large intraperitoneal dissemination has already occurred. An accurate preoperative assessment of the tumor dissemination is pivotal for adequate counseling among risks and benefits of an aggressive surgical procedure, often required to achieve a complete cytoreduction. When performed by an experienced sonographer, ultrasound has an invaluable role in the primary diagnosis of gynecological cancer, in the assessment of tumor extent in the pelvis and abdominal cavity; however, there is a paucity of data on its use in the evaluation of the extent of disease of such patients. EVIDENCE ACQUISITION: The search retrieved 208 articles in the best matching results list. Selection by abstract and full-text, yielded 15 publications that contained information on the role of ultrasound examination in the assessment of diffused peritoneal malignancies. EVIDENCE SYNTHESIS: Sonographic appearance of metastatic nodules in peritoneum and omentum were firstly analyzed in preliminar descriptive studies, together with a systematic method to scan the abdomen and pelvis in in the staging of diffused gynecological malignancies. To date, three prospective studies mainly focused on the specific role of ultrasound (without comparison with other imaging modalities) in the evaluation of intra-abdominal tumor extension in ovarian cancer patients. In these studies, authors were in agreement to conclude that ultrasound has a very reliable role in the staging of ovarian cancer. In particular, ultrasound examination showed a high sensitivity (range 81.4-91%) and specificity (range 88-96%) in the diagnosis of peritoneal carcinomatosis, as well as in omental involvement (sense 67-94%, specificity 90%). In a recent prospective study ultrasound shows similar accuracy of CT scan in the staging of ovarian cancer patients (7

Objective. About 30% of Adult type granulosa cell tumors of the ovary (AGCTs) are diagnosed in fertile age. In stage I, conservative surgery (fertility-sparing surgery, FSS), either unilateral salpingo-oophorectomy (USO) or cystectomy are possible options. The aim of this study is to compare oncological outcomes of FSS and radical surgery (RS) in apparently stage I AGCTs treated within the MITO group (Multicenter Italian Trials in Ovarian cancer). Methods. Survival curves were calculated using the Kaplan-Meiermethod and comparedwith log-rank test. The role of clinicopathological variables as prognostic factors for survival was assessed using Cox's regression. Results. Two-hundred and twenty-nine patients were included; 32.6% received FSS, 67.4% RS. In the FSS group, 62.8% underwent USO, 16.7% cystectomy, 20.5% cystectomy followed by USO. After a median follow up of 84 months, median DFS was significantly worse in the FSS-group (10 yr DFS 50% vs 74%, in FSS and RS group, p = 0.006). No significant difference was detected between RS and USO (10 yr DFS 75% vs 70%, p = 0.5). Cystectomy-group showed a significantly worse DFS compared to USO (10 yr DFS 16% vs 70%, p b 0.001). Patients receiving cystectomy and subsequent USO showed a better prognosis, even though significantly worse compared to USO (10 yr DFS 41% vs 70%, p=0.05). Between FSS and RS, no difference in OS was detected. Atmultivariate analysis,FIGO stage IC and cystectomy retained significant predictive value for worse survival. Conclusions. This study supports the oncological safety of FSS in stage I AGCTs, provided that cystectomy is avoided; USO should be the preferred approach

OBJECTIVES: To describe the clinical and ultrasound characteristics of serous cystadenofibromas in the adnexa. METHODS: This is a retrospective study. From the International ovarian tumor analysis (IOTA) database we identified patients with a histological diagnosis of serous cystadenofibroma, who had undergone preoperative ultrasound examination by an experienced ultrasound examiner between 1999 and 2012. In the IOTA database containing prospectively collected data, the tumors were described using the terms and definitions of the International Ovarian Tumor Analysis (IOTA) group. In addition, three authors reviewed, first independently and then together, ultrasound images of serous cystadenofibromas and described them using pattern recognition. RESULTS: We identified 233 women with a histological diagnosis of serous cystadenofibroma. In the IOTA database, most (67.4%) were described as containing solid components (157/233) but 19.3% (45/233) were described as multilocular cysts and 13.3% (31/233) as unilocular cysts. Papillary projections were described in 52.4% (122/233) of the cystadenofibromas. In 79.5% (97/122) of the cysts with papillary projections color Doppler signals were absent in the papillary projections. Most cystadenofibromas (83.7%, 195/233) manifested no or minimal color Doppler signals. On retrospective analysis of 201 ultrasound images of serous cystadenofibromas using pattern recognition we identified 10 major types of ultrasound appearance. The most common pattern was a unilocular solid cyst with one or more papillary projections (25.9%, 52/201). The second most common pattern was a multilocular solid mass with small solid component(s) but no papillary projections (19.4%, 39/201). The third and fourth most common patterns were multilocular cyst (16.9%, 34/201) and unilocular cyst (11.9%, 24/201). Using pattern recognition, shadowing was identified in 39.8% (80/201) of the tumors, and microcystic appearance of the papillary projections was observe