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1.
  • Moro, F., et al. (author)
  • Imaging in gynecological disease (20) : clinical and ultrasound characteristics of adnexal torsion
  • 2020
  • In: Ultrasound in Obstetrics and Gynecology. - : Wiley. - 0960-7692 .- 1469-0705. ; 56:6, s. 934-943
  • Journal article (peer-reviewed)abstract
    • 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 report in 167/241 (69.3%) patients, the whirlpool sign in 178/226 (78.8%) patients, absent color Doppler signals in the twisted organ in 119/269 (44.2%) patients and the follicular ring sign in 51/134 (38.1%) patients. On retrospective review of images and videoclips, ovarian stromal edema with or without peripherally displaced antral follicles (201/254; 79.1%) and the whirlpool sign (139/153; 90.8%) were the most commonly detected features of adnexal torsion. Conclusion: Most patients with surgically confirmed adnexal torsion are of reproductive age and present with acute or subacute pain. Common ultrasound signs are an enlarged adnexa, the whirlpool sign, ovarian stromal edema with or without peripherally displaced antral follicles and free fluid in the pelvis. The follicular ring sign and absence of Doppler signals in the twisted organ are slightly less common signs. Recognizing ultrasound signs of adnexal torsion is important so that the correct treatment, i.e. surgery without delay, can be offered.
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2.
  • Virgilio, B. A., et al. (author)
  • Imaging in gynecological disease (16) : clinical and ultrasound characteristics of serous cystadenofibromas in adnexa
  • 2019
  • In: Ultrasound in Obstetrics and Gynecology. - : Wiley. - 0960-7692 .- 1469-0705. ; 54:6, s. 823-830
  • Journal article (peer-reviewed)abstract
    • Objective: To describe the clinical and ultrasound characteristics of serous cystadenofibromas in the adnexa. Methods: This was a retrospective study of patients identified in the International Ovarian Tumor Analysis (IOTA) database, who had a histological diagnosis of serous cystadenofibroma and had undergone preoperative ultrasound examination by an experienced ultrasound examiner, between 1999 and 2012. In the IOTA database, which contains data collected prospectively, the tumors were described using the terms and definitions of the 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 cystadenofibromas (67.4%; 157/233) were described as containing solid components 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, 10 major types of ultrasound appearance were identified. The most common pattern was a unilocular solid cyst with one or more papillary projections, but no other solid components (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 multi- or bilocular 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 observed in 34 (38.6%) of the 88 tumors containing papillary projections. Conclusions: The ultrasound features of serous cystadenofibromas vary. The most common pattern is a unilocular solid cyst with one or more papillary projections but no other solid components, with absent color Doppler signals. Most serous cystadenofibromas were poorly vascularized on color Doppler examination and many manifested acoustic shadowing.
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3.
  • Moro, F., et al. (author)
  • Imaging in gynecological disease (13) : clinical and ultrasound characteristics of endometrioid ovarian cancer
  • 2018
  • In: Ultrasound in obstetrics & gynecology : the official journal of the International Society of Ultrasound in Obstetrics and Gynecology. - : Wiley. - 1469-0705. ; 52:4, s. 535-543
  • Journal article (peer-reviewed)abstract
    • OBJECTIVE: To describe the clinical and ultrasound characteristics of ovarian pure endometrioid carcinomas.METHODS: This was a retrospective multicenter study of patients with a histological diagnosis of pure endometrioid carcinoma. We identified 161 patients from the International Ovarian Tumor Analysis (IOTA) database who had undergone preoperative ultrasound examination by an experienced ultrasound examiner between 1999 and 2016, and another 78 patients from the databases of the departments of gynecological oncology in the participating centers. All tumors were described using IOTA terminology. In addition, one author reviewed all available ultrasound images and described them using pattern recognition.RESULTS: Median age of the 239 patients was 55 years (range, 19-88 years). On ultrasound examination, two (0.8%) endometrioid carcinomas were described as unilocular cysts, three (1.3%) as multilocular cysts, 37 (15.5%) as unilocular-solid cysts, 115 (48.1%) as multilocular-solid cysts and 82 (34.3%) as solid masses. Median largest tumor diameter was 102.5 mm (range, 20-300 mm) and median largest diameter of the largest solid component was 63 mm (range, 9-300 mm). Papillary projections were present in 70 (29.3%) masses. Most cancers (188 (78.7%)) were unilateral. In 49 (20.5%) cases, the cancer was judged by the pathologist to develop from endometriosis. These cancers, compared with those without evidence of tumor developing from endometriosis, more often manifested papillary projections on ultrasound (46.9% (23/49) vs 24.7% (47/190)), were less often bilateral (8.2% (4/49) vs 24.7% (47/190)) and less often associated with ascites (6.1% (3/49) vs 28.4% (54/190)) and fluid in the pouch of Douglas (24.5% (12/49) vs 48.9% (93/190)). Retrospective analysis of available ultrasound images using pattern recognition revealed that many tumors without evidence of tumor developing from endometriosis (36.3% (41/113)) had a large central solid component entrapped within locules, giving the tumor a cockade-like appearance.CONCLUSIONS: Endometrioid cancers are usually large, unilateral, multilocular-solid or solid tumors. The ultrasound characteristics of endometrioid carcinomas developing from endometriosis differ from those without evidence of tumor developing from endometriosis, the former being more often unilateral cysts with papillary projections and no ascites.
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4.
  • Moro, F., et al. (author)
  • Imaging in gynecological disease (22) : clinical and ultrasound characteristics of ovarian embryonal carcinomas, non-gestational choriocarcinomas and malignant mixed germ cell tumors
  • 2021
  • In: Ultrasound in Obstetrics and Gynecology. - : Wiley. - 0960-7692 .- 1469-0705. ; 57:6, s. 987-994
  • Journal article (peer-reviewed)abstract
    • Objective: To describe the clinical and ultrasound characteristics of three types of rare malignant ovarian germ cell tumor: embryonal carcinoma, non-gestational choriocarcinoma and malignant mixed germ cell tumor. Methods: This was a retrospective multicenter study. From the International Ovarian Tumor Analysis (IOTA) database, we identified patients with a histological diagnosis of ovarian embryonal carcinoma, non-gestational choriocarcinoma or malignant mixed germ cell tumor, who had undergone preoperative ultrasound examination by an experienced ultrasound examiner between 2000 and 2020. Additional patients with the same histology were identified from the databases of the departments of gynecological oncology in the participating centers. All tumors were described using IOTA terminology. Three examiners reviewed all available ultrasound images and described them using pattern recognition. Results: One patient with embryonal carcinoma, five patients with non-gestational ovarian choriocarcinoma and seven patients with ovarian malignant mixed germ cell tumor (six primary tumors and one recurrence) were identified. Seven patients were included in the IOTA studies and six patients were examined outside of the IOTA studies. The median age at diagnosis was 26 (range, 14–77) years. Beta-human chorionic gonadotropin levels were highest in non-gestational choriocarcinomas and alpha-fetoprotein levels were highest in malignant mixed germ cell tumors. Most tumors were International Federation of Gynecology and Obstetrics (FIGO) Stage I (9/12 (75.0%)). All tumors were unilateral, and the median largest diameter was 129 (range, 38–216) mm. Of the tumors, 11/13 (84.6%) were solid and 2/13 (15.4%) were multilocular-solid; 9/13 (69.2%) manifested abundant vascularization on color Doppler examination. Using pattern recognition, the typical ultrasound appearance was a large solid tumor with inhomogeneous echogenicity of the solid tissue and often dispersed cysts which, in most cases, were small and irregular. Some tumors had smooth contours while others had irregular contours. Conclusions: A unilateral, large solid tumor with inhomogeneous echogenicity of the solid tissue and with dispersed small cystic areas in a young woman should raise the suspicion of a rare malignant germ cell tumor. This suspicion can guide the clinician to test tumor markers specific for malignant germ cell tumors.
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5.
  • Moro, F., et al. (author)
  • Imaging in gynecological disease (27) : clinical and ultrasound characteristics of recurrent ovarian stromal cell tumors
  • In: Ultrasound in Obstetrics and Gynecology. - 0960-7692.
  • Journal article (peer-reviewed)abstract
    • Objective: To describe the clinical and ultrasound characteristics of recurrent granulosa cell and Sertoli–Leydig cell tumors. Methods: This was a retrospective observational study performed at Fondazione Policlinico Universitario A. Gemelli, Istituto di Ricovero e Cura a Carattere Scientifico, IRCCS, Rome (Gemelli center). Patients with a histological diagnosis of recurrent granulosa cell tumor or Sertoli–Leydig cell tumor were identified from the database of the Department of Gynecological Oncology. Those who had undergone a preoperative ultrasound examination at the Gemelli center between 2012 and 2020 were included, and the data retrieved from the original ultrasound reports. In all of these reports, the recurrent tumors were described using International Ovarian Tumor Analysis (IOTA) terminology. If a patient had more than one episode of relapse, information from all episodes was collected. If there was more than one recurrent tumor at the same ultrasound examination, all tumors were included. One expert sonographer also reviewed all available ultrasound images to identify typical ultrasound patterns using pattern recognition. Results: We identified 30 patients with a histological diagnosis of recurrent granulosa cell tumor (25 patients, 55 tumors) or Sertoli–Leydig cell tumor (five patients, seven tumors). All 30 had undergone at least one preoperative ultrasound examination at the Gemelli center and were included. These women had a total of 66 episodes of relapse, of which a preoperative ultrasound examination had been performed at the Gemelli center in 34, revealing 62 recurrent lesions: one in 22/34 (64.7%) episodes of relapse, two in 4/34 (11.8%) episodes and three or more in 8/34 (23.5%) episodes. Most recurrent granulosa cell tumors (38/55, 69.1%) and recurrent Sertoli–Leydig tumors (6/7, 85.7%) were classified as solid or multilocular-solid tumors, while 8/55 (14.5%) recurrent granulosa cell tumors and 1/7 (14.3%) recurrent Sertoli–Leydig cell tumors were unilocular cysts and 9/55 (16.4%) recurrent granulosa cell tumors were multilocular cysts. The nine unilocular cysts had contents that were anechoic (n = 2) or had low-level echogenicity (n = 7), had either smooth (n = 4) or irregular (n = 5) internal cyst walls, and ranged in largest diameter from 8 to 38 mm, with three being < 20 mm and five being 20–30 mm. On retrospective review of the images, two typical ultrasound patterns were described: small solid tumor measuring < 2 cm (15/62, 24.2%) and tumor with vascularized echogenic ground-glass-like content (12/62, 19.4%). Conclusions: Some granulosa cell and Sertoli–Leydig cell recurrences manifest one of two typical ultrasound patterns, while some appear as unilocular cysts. These are usually classified as benign, but in patients being followed up for a granulosa cell tumor or Sertoli–Leydig cell tumor, a unilocular cyst should be considered suspicious of recurrence.
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6.
  • Epstein, E, et al. (author)
  • Erratum
  • 2018
  • In: Ultrasound in obstetrics & gynecology : the official journal of the International Society of Ultrasound in Obstetrics and Gynecology. - : Wiley. - 1469-0705. ; 52:5, s. 684-684
  • Journal article (peer-reviewed)
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  • Eriksson, L. S.E., et al. (author)
  • Ultrasound-based risk model for preoperative prediction of lymph-node metastases in women with endometrial cancer : model-development study
  • 2020
  • In: Ultrasound in Obstetrics and Gynecology. - : Wiley. - 0960-7692 .- 1469-0705. ; 56:3, s. 443-452
  • Journal article (peer-reviewed)abstract
    • 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 higher than that of endometrial biopsy alone or combined endometrial biopsy and ultrasound at any given risk threshold. Conclusions: Based on endometrial biopsy results and clinical and ultrasound characteristics, the individual risk of lymph-node metastases in women with endometrial cancer can be estimated reliably before surgery. The model is superior to risk classification by endometrial biopsy alone or in combination with ultrasound.
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12.
  • Guerriero, S., et al. (author)
  • Imaging of gynecological disease (6): clinical and ultrasound characteristics of ovarian dysgerminoma
  • 2011
  • In: Ultrasound in Obstetrics & Gynecology. - : Wiley. - 1469-0705 .- 0960-7692. ; 37:5, s. 596-602
  • Journal article (peer-reviewed)abstract
    • Objectives To describe the clinical history and ultrasound findings in patients with ovarian dysgerminoma. Methods This was a retrospective study of patients with a histological diagnosis of ovarian dysgerminoma who had undergone preoperative ultrasound examination. The patients were identified from the databases of 11 ultrasound centers. The tumors were described by the principal investigator at each contributing center on the basis of ultrasound images, ultrasound reports and research protocols (when applicable) using the terms and definitions of the International Ovarian Tumor Analysis (IOTA) group. In addition, three authors reviewed all available electronic ultrasound images (gray-scale images and color/power Doppler images were available for 18 patients and 14 patients, respectively) and described them using subjective evaluation of gray-scale and color Doppler ultrasound findings (here called pattern recognition). Results Twenty-one patients with ovarian dysgerminoma were identified (including one woman with bilateral masses). Twenty patients had a primary ovarian dysgerminoma (including the one with bilateral masses) and one patient had a recurrence of dysgerminoma in her retained ovary. One of the 21 patients was pregnant. All tumors except one were pure dysgerminomas, one being a mixed germinal cell tumor with 30% dysgerminoma component. Median age was 20 (range, 16-31) years. Information on clinical symptoms was available for 18 patients. In four patients, the tumor was detected incidentally, whereas 14 patients presented with one or more of the following symptoms: acute pain (n = 4), chronic pain (n = 8), bloating (n = 8), menstrual disorders (n = 5) and infertility problems (n = 1). One (5%) patient had ascites. Using the IOTA terms and definitions, all but one dysgerminoma were moderately (43%) or very well (50%) vascularized solid tumors. One tumor was multilocular-solid. According to pattern recognition, most dysgerminomas were highly vascularized, purely solid tumors with heterogeneous internal echogenicity divided into several lobules, had a smooth and sometimes lobulated contour and were well-defined relative to the surrounding organs. Conclusion The ultrasound finding of a highly vascularized, large, solid, lobulated adnexal mass with irregular internal echogenicity in a woman 20-30 years old should raise the suspicion of ovarian dysgerminoma. Copyright (C) 2011 ISUOG. Published by John Wiley & Sons, Ltd.
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  • Mascilini, F., et al. (author)
  • Imaging in gynecological disease (10): clinical and ultrasound characteristics of decidualized endometriomas surgically removed during pregnancy
  • 2014
  • In: Ultrasound in Obstetrics & Gynecology. - : Wiley. - 1469-0705 .- 0960-7692. ; 44:3, s. 354-360
  • Journal article (peer-reviewed)abstract
    • Objectives To describe the clinical history and ultrasound findings in women with decidualized endometriomas surgically removed during pregnancy. Methods In this retrospective study, women with a histological diagnosis of decidualized endometrioma during pregnancy who had undergone preoperative ultrasound examination were identified from the databases of seven ultrasound centers. The ultrasound appearance of the tumors was described on the basis of ultrasound images, ultrasound reports and research protocols (when applicable) by one author from each center using the terms and definitions of the International Ovarian Tumor Analysis (IOTA) group. In addition, two authors reviewed together available digital ultrasound images and used pattern recognition to describe the typical ultrasound appearance of decidualized endometriomas. Results Eighteen eligible women were identified. Median age was 34 (range, 20-43) years. Median gestational age at surgical removal of the decidualized endometrioma was 18 (range, 11-41) weeks. Seventeen women (94%) were asymptomatic and one presented with pelvic pain. In three of the 18 women an ultrasound diagnosis of endometrioma had been made before pregnancy. The original ultrasound examiner was uncertain whether the mass was benign or malignant in 10 (56%) women and suggested a diagnosis of benignity in nine (50%) women, borderline in eight women (44%), and invasive malignancy in one (6%) woman. Seventeen decidualized endometriomas contained a papillary projection, and in 16 of these at least one of the papillary projections was vascularized at power or color Doppler examination. The number of cyst locules varied between one (n=11) and four. No woman had ascites. When using pattern recognition, most decidualized endometriomas (14/17, 82%) were described as manifesting vascularized rounded papillary projections with a smooth contour in an ovarian cyst with one or a few cyst locules and ground-glass or low-level echogenicity of the cyst fluid. Conclusions Rounded vascularized papillary projections with smooth contours within an ovarian cyst with cyst contents of ground-glass or low-level echogenicity are typical of surgically removed decidualized endometriomas in pregnant women, most of whom are asymptomatic. Copyright (C) 2014 ISUOG. Published by John Wiley & Sons Ltd.
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  • Verbakel, J. Y., et al. (author)
  • Validation of ultrasound strategies to assess tumor extension and to predict high-risk endometrial cancer in women from the prospective IETA (International Endometrial Tumor Analysis)-4 cohort
  • 2020
  • In: Ultrasound in Obstetrics and Gynecology. - : Wiley. - 0960-7692 .- 1469-0705. ; 55:1, s. 115-124
  • Journal article (peer-reviewed)abstract
    • 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: In 1275 patients with measurable lesions, the sensitivity and specificity of SA for detecting deep MI was 70% and 80%, respectively, in patients with a Grade-1 or -2 endometrioid or mucinous tumor vs 76% and 64% in patients with a Grade-3 endometrioid or mucinous or a non-endometrioid tumor. The corresponding values for the detection of CSI were 51% and 94% vs 50% and 91%. Tumor AP diameter and tumor/uterine AP diameter ratio showed the best performance for predicting deep MI (area under the receiver–operating characteristics curve (AUC) of 0.76 and 0.77, respectively), and Dist-OCO had the best performance for predicting CSI (AUC, 0.72). The proportion of patients classified correctly as having high-risk cancer was 80% when simply combining SA with biopsy grade vs 80% and 74% when using the subjective and objective two-step strategies, respectively. The subjective and objective models had an AUC of 0.76 and 0.75, respectively, when applied to Grade-1 and -2 endometrioid tumors. Conclusions: In the hands of experienced ultrasound examiners, SA was superior to ultrasound measurements for the prediction of deep MI and CSI of endometrial cancer, especially in patients with a Grade-1 or -2 tumor. The mathematical models for the prediction of high-risk cancer performed as expected. The best strategies for predicting high-risk endometrial cancer were combining SA with biopsy grade and the subjective two-step strategy, both having an accuracy of 80%.
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  • Verri, D, et al. (author)
  • GestaTIonal TrophoblAstic NeoplasIa Ultrasound assessMent: TITANIUM study
  • 2019
  • In: International journal of gynecological cancer : official journal of the International Gynecological Cancer Society. - : BMJ. - 1525-1438. ; 29:7, s. 1216-1220
  • Journal article (peer-reviewed)abstract
    • 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 HypothesisTITANIUM 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 CriteriaPatients 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 EndpointsOur 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 SizeThe 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 (either two ultrasound parameters in addition to the risk score or three ultrasound variables statistically significant at univariate analysis) to predict resistance to single-drug therapy in low-risk patients.Estimated Dates for Completing Accrual and Presenting ResultsThe accrual started in February 2019. Additional referral centers for gestational trophoblastic disease, with similar ultrasound expertise, are welcome to participate in the study. Enrollment should be completed by December 2021, and analysis will be conducted in December 2023.Trial RegistrationThe study received the Ethical Committee approval of the Coordinator Center (Rome) in January 2019 (Protocol No. 0004668/19).
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  • Di Legge, A., et al. (author)
  • Clinical and ultrasound characteristics of surgically removed adnexal lesions with largest diameter ≤ 2.5 cm : a pictorial essay
  • 2017
  • In: Ultrasound in Obstetrics and Gynecology. - : Wiley. - 0960-7692. ; 50:5, s. 648-656
  • Journal article (peer-reviewed)abstract
    • Objectives: To describe the ultrasound characteristics, indications for surgery and histological diagnoses of surgically removed adnexal masses with a largest diameter of ≤ 2.5 cm (very small tumors), to estimate the sensitivity and specificity of diagnosis of malignancy by subjective assessment of ultrasound images of very small tumors and to present a collection of ultrasound images of surgically removed very small tumors, with emphasis on those causing diagnostic difficulty. Methods: Information on surgically removed adnexal tumors with a largest diameter of ≤ 2.5 cm was retrieved from the ultrasound databases of seven participating centers. The ultrasound images were described using the International Ovarian Tumor Analysis terminology. The original diagnosis, based on subjective assessment of the ultrasound images by the ultrasound examiner, was used to calculate the sensitivity and specificity of diagnosis of malignancy. Results: Of the 129 identified adnexal masses with largest diameter ≤ 2.5 cm, 104 (81%) were benign, 15 (12%) borderline malignant and 10 (8%) invasive tumors. The main indication for performing surgery was suspicion of malignancy in 22% (23/104) of the benign tumors and in all 25 malignant tumors. None of the malignant tumors was a unilocular cyst (vs 50% of the benign tumors), all malignancies contained solid components (vs 43% of the benign tumors), 80% of the borderline tumors had papillary projections (vs 21% of the benign tumors and 20% of the invasive malignancies) and all invasive tumors and 80% of the borderline tumors were vascularized on color/power Doppler examination (vs 44% of the benign tumors). The ovarian crescent sign was present in 85% of the benign tumors, 80% of the borderline tumors and 50% of the invasive malignancies. The sensitivity of diagnosis of malignancy by subjective assessment of ultrasound images was 100% (25/25) and the specificity was 86% (89/104). Excluding unilocular cysts, the specificity was 71% (37/52). Analysis of images illustrated the difficulty in distinguishing benign from borderline very small cysts with papillations and benign from malignant very small well vascularized (color score 3 or 4) solid adnexal tumors. Conclusions: Very small malignant tumors manifest generally accepted ultrasound signs of malignancy. Small unilocular cysts are usually benign, while small non-unilocular masses, particularly ones with solid components, incur a risk of malignancy and pose a clinical dilemma.
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  • Epstein, E., et al. (author)
  • Gray-scale and color Doppler ultrasound characteristics of endometrial cancer in relation to stage, grade and tumor size
  • 2011
  • In: Ultrasound in Obstetrics & Gynecology. - : Wiley. - 1469-0705 .- 0960-7692. ; 38:5, s. 586-593
  • Journal article (peer-reviewed)abstract
    • Objectives To describe the gray-scale and vascular characteristics of endometrial cancer in relation to stage, grade and size using two-dimensional (2D)/three-dimensional (3D) transvaginal ultrasound. Methods This was a prospective multicenter study including 144 women with endometrial cancer undergoing transvaginal ultrasound before surgery. The sonographic characteristics assessed were echogenicity, endometrial/myometrial border, fibroids, vascular pattern, color score and tumor/uterus anteroposterior (AP) ratio. Histological assessment of tumor stage, grade, type and growth pattern was performed. Results Hyperechoic or isoechoic tumors were more often seen in Stage IA cancer, whereas mixed or hypoechoic tumors were more often found in cancers of Stage IB or greater (P = 0.003). Hyperechogenicity was more common in Grade 1-2 tumors (i.e. well or moderately differentiated) (P = 0.02) and in tumors with a tumor/uterine AP ratio of <50% (P = 0.002), whereas a non-hyperechoic appearance was more commonly found in Grade 3 tumors (i.e. poorly differentiated) and in tumors with a tumor/uterine AP ratio of >= 50%. Multiple global vessels were more often seen in tumors of Stage IB or greater than in Stage IA tumors (P = 0.02), in Grade 3 tumors than in Grade 1 and 2 tumors (P = 0.02) and in tumors with a tumor/uterine AP ratio of >= 50% (P < 0.001). A moderate/high color score was significantly more common in tumors of higher stage (P = 0.03) and larger size (P = 0.001). Conclusion The sonographic appearance of endometrial cancer is significantly associated with tumor stage, grade and size. More advanced tumors often have a mixed/hypoechoic echogenicity, a higher color score and multiple globally entering vessels, whereas less advanced tumors are more often hyperechoic and have no or a low color score. Copyright (C) 2011 ISUOG. Published by John Wiley & Sons, Ltd.
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  • Mascilini, F., et al. (author)
  • Ovarian masses with papillary projections diagnosed and removed during pregnancy : ultrasound features and histological diagnosis
  • 2017
  • In: Ultrasound in Obstetrics and Gynecology. - : Wiley. - 0960-7692. ; 50:1, s. 116-123
  • Journal article (peer-reviewed)abstract
    • Objective: To elucidate the ultrasound features that can discriminate between benign and malignant ovarian cysts with papillary projections but no other solid component in pregnant women. Methods: Thirty-four women with an ultrasound diagnosis of an ovarian cyst with papillary projections but no other solid component that had been removed surgically during pregnancy were identified from the databases of four ultrasound units. Some clinical and ultrasound information was collected prospectively. Missing information was obtained retrospectively from ultrasound images, ultrasound reports and patient records. Using prospectively and retrospectively collected data, the ultrasound appearance of the tumors was described using the terms and definitions of the International Ovarian Tumor Analysis group. The ultrasound characteristics were compared with the histological diagnosis. Results: Of the 34 cases included, 19 (56%) lesions were benign (16 decidualized endometriomas, one cystadenofibroma, one simple cyst, one struma ovarii), 12 (35%) were borderline tumors and three (9%) were primary invasive tumors (two immature teratomas, one endometrioid cystadenocarcinoma). The contour of the cyst papillations was smooth in 79% (15/19) of benign tumors vs 27% (4/15) of malignant tumors (P = 0.002). The cystic content showed ground-glass echogenicity in 74% (14/19) of benign tumors vs 13% (2/15) of malignant tumors (P = 0.0006). All ovarian masses with smooth papillations and ground-glass content (n = 12) were decidualized endometriomas. The papillary projections were vascularized and the color score was 3 or 4 in 88% (14/16) of decidualized endometriomas vs 42% (5/12) of borderline tumors (P = 0.013). Conclusions: In pregnant women, ovarian cysts with ground-glass echogenicity and papillations with a smooth contour on ultrasound are most likely to be decidualized endometriomas. Cysts with anechoic or low-level echogenicity and papillations with an irregular contour suggest borderline malignancy.
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