Efficacy of IOTA simple rules, O-RADS, and CA125 to distinguish benign and malignant adnexal masses.

OBJECTIVE: Ovarian cancer is the most deadly deadliest gynecological tumor in the female reproductive system. Therefore, the present study sought to determine the diagnostic performance of International Ovarian Tumor Analysis Simple Rules (IOTA SR), the Ovarian-Adnexal Reporting and Data System (O-RADS), and Cancer Antigen 125 (CA125) in discriminating benign and malignant ovarian tumors. The study also assessed whether a combination of the two ultrasound categories systems and CA125 can improve the diagnostic performance. METHODS: A total of 453 patients diagnosed with ovarian tumors were retrospectively enrolled from Fujian Cancer Hospital between January 2017 and September 2020. The data collected from patients included age, maximum lesion diameter, location, histopathology, levels of CA125, and detailed ultrasound reports. Additionally, all ultrasound images were independently assessed by two ultrasound physicians with more than 5 years of experience in the field, according to the IOTA simple rules and O-RADS guidelines. Furthermore, the area under the curve (AUC), sensitivity, and specificity of the above mentioned predictors were calculated using the receiver operating characteristic curve. RESULTS: Out of the 453 patients, 184 had benign lesions, while 269 had malignant ovarian tumors. In addition, the AUCs of IOTA SR, O-RADS, and CA125 in the overall population were 0.831, 0.804, and 0.812, respectively, and the sensitivities of IOTA SR, O-RADS, and CA125 were 94.42, 94.42, and 80.30%, respectively. On the other hand, the AUCs of IOTA SR combined with CA125, O-RADS combined with CA125, and IOTA SR plus O-RADS combined with CA125 were 0.900, 0.891, and 0.909, respectively. The findings also showed that the AUCs of a combination of the three approaches were significantly higher than those of individual strategies (p<0.05) but not significantly higher than the AUC of a combination of two methods (p>0.05). CONCLUSION: The findings showed that a combination of IOTA SR or O-RADS in combination with CA125 may improve the ability to distinguish benign from malignant ovarian tumors.

Adnexal Masses in Pregnancy.

With the increased use and quality of ultrasound in pregnancy, adnexal masses are being encountered with greater frequency. Fortunately, the vast majority of such masses are benign and resolve on their own. However, it is important for clinicians to be familiar with the types of adnexal masses that may be visualized in pregnancy to best counsel these women. In addition, complications such as ovarian torsion, and rarely, even malignancy can occur. In this article, we review the available literature on this subject to help guide the clinician in the diagnosis and management of adnexal masses in pregnancy.

Performance of IOTA ADNEX model in evaluating adnexal masses in a gynecological oncology center in China.

OBJECTIVE: To evaluate the diagnostic accuracy of the International Ovarian Tumor Analysis (IOTA) Assessment of Different NEoplasias in the adneXa (ADNEX) model in the preoperative diagnosis of adnexal masses using data from a gynecological oncology center in China. METHODS: This was a single-center, retrospective diagnostic accuracy study based on ultrasound data collected prospectively, between May and December 2017, from 278 patients with at least one adnexal (ovarian, paraovarian or tubal) mass. Clinical and pathologic information, serum CA 125 level and ultrasonographic findings were collected. All patients underwent surgery and the histopathological diagnosis was used as reference standard. The final diagnosis was classified into five tumor types according to the ADNEX model: benign ovarian tumor, borderline ovarian tumor (BOT), Stage-I ovarian cancer (OC), Stages-II-IV OC and ovarian metastasis. Receiver-operating characteristics (ROC) curve analysis was used to evaluate the diagnostic accuracy of the ADNEX model, with and without inclusion of CA 125 level in the model. RESULTS: Of the 278 women included, 203 (73.0%) had a benign ovarian tumor and 75 (27.0%) had a malignant ovarian tumor, including 18 (6.5%) with BOT, 17 (6.1%) with Stage-I OC, 32 (11.5%) with Stages-II-IV OC and eight (2.9%) with ovarian metastasis. The performance of the IOTA ADNEX model was good for discriminating between benign and malignant tumors, with an area under the ROC curve (AUC) of 0.94 (95% CI, 0.91-0.97) when CA 125 was included in the model and AUC of 0.93 (95% CI, 0.90-0.96) without CA 125. The AUC values of the model including CA 125 ranged between 0.61 and 0.99 for distinguishing between the different types of tumor, and it showed excellent performance in discriminating between a benign ovarian tumor and Stages-II-IV OC, with an AUC of 0.99 (95% CI, 0.97-1.00). The performance of the model was less effective at distinguishing between BOT and Stage-I OC and between Stages-II-IV OC and ovarian metastasis, with AUC values of 0.61 (95% CI, 0.43-0.77) and 0.78 (95% CI, 0.62-0.90), respectively. Although inclusion of CA 125 did not alter the performance of the ADNEX model in discriminating between benign and malignant lesions (AUC of 0.94 and 0.93 with and without CA 125 level, respectively; P = 0.54), the inclusion of CA 125 in the model improved its performance in discriminating between Stage-I OC and Stages-II-IV OC (AUC increased from 0.81 to 0.92; P = 0.04) and between Stages-II-IV OC and metastatic cancer (AUC increased from 0.58 to 0.78; P = 0.01). CONCLUSIONS: The IOTA ADNEX model showed good to excellent performance in distinguishing between benign and malignant adnexal masses and between the different types of ovarian tumor in a Chinese setting. Based on our findings, the ADNEX model has high value in clinical practice and can aid in the preoperative diagnosis of patients with an adnexal mass. Copyright © 2019 ISUOG. Published by John Wiley & Sons Ltd.

Comparison of Qualitative (Time Intensity Curve Analysis), Semi-Quantitative, and Quantitative Multi-Phase 3T DCEMRI Parameters as Predictors of Malignancy in Adnexal.

Objective: The present study aimed to compare the qualitative (time intensity curve analysis), the semi-quantitative and the quantitative multiphase 3T dynamic contrast-enhanced (DCE) MRI parameters as predictors of malignancy in adnexal masses. Materials and Methods: In this prospective study, women with an adnexal mass who were scheduled for surgical resection or were followed for more than one year period to confirm the benignity of their lesions, underwent multiphase 3T DCE-MRI. The qualitative (time intensity curve), semi-quantitative (SImax, SIrel, WIR) and quantitative (Ktrans, Kep, Vb) analyses were performed on DCE-MRI sequences and their predictive values were compared. Results: A total of 17 benign and 14 malignant lesions were included. According to the qualitative analysis, none of the lesions with Type I time intensity curves (TIC) were malignant and none of the masses with Type III TICs were benign. The accuracy of the quantitative parameters in detection of malignancy was found to be higher than that of semi-quantitative variables, particularly when calculated for a small ROI within the high signal area of the mass (sROI) rather than the largest ROI including the whole mass (lROI), and when inter-MRI variations were omitted using ratios. The Kep(tumor)/Kep(myometrium) ratio measured from sROI was the best parameter for differentiating a malignant lesion with a sensitivity of 100% and a specificity of 92.3%. Conclusion: We concluded that a Type I TIC confirms a benign lesion, and a type III TIC confirms the malignancy and further evaluation is not recommended for these lesions. So complementary quantitative analysis is only recommended for adnexal masses with type II TICs.

Reliability of IOTA score and ADNEX model in the screening of ovarian malignancy in postmenopausal women.

BACKGROUND: The IOTA (International Ovarian Tumor Analysis) group has developed the ADNEX (Assessment of Different NEoplasias in the adneXa) model to predict the risk that an ovarian mass is benign, borderline or malignant. This study aimed to test reliability of these risks prediction models to improve the performance of pelvic ultrasound and discriminate between benign and malignant cysts. MATERIAL AND METHODS: Postmenopausal women with an adnexal mass (including ovarian, para-ovarian and tubal) and who underwent a standardized ultrasound examination before surgery were included. Prospectively and retrospectively collected data and ultrasound appearances of the tumors were described using the terms and definitions of the IOTA group and tested in accordance with the ADNEX model and were compared to the final histological diagnosis. RESULTS: Of the 107 menopausal patients recruited between 2011 and 2016, 14 were excluded (incomplete inclusion criteria). Thus, 93 patients constituted a cohort in whom 89 had benign cysts (83 ovarian and 6 tubal or para-ovarian cysts), 1 had border line tumor and 3 had invasive ovarian cancers (1 at first stage, 1 at advanced stage and 1 metastatic tumor in the ovary). The overall prevalence of malignancy was 4.3%. Every benign ovarian cyst was classified as probably benign by IOTA score which showed also a high specificity with the totality of probably malignant lesion proved malignant by histological exam. The limit of this score was the important rate of not classified or undetermined cysts. However, the malignancy risks calculated by ADNEX model allowed identifying the totality of malignancy. Thus, the combination of the two methods of analysis showed a sensitivity and specificity rates of respectively 100% and 98%. Evaluation of malignancy risks by these 2 tests highlighted a negative predictive value of 100% (there was no case of false negative) and a positive predictive value of 80%. DISCUSSION AND CONCLUSION: On the basis of our findings, the IOTA classification and the ADNEX multimodal algorithm used as risks prediction models can improve the performance of pelvic ultrasound and discriminate between benign and malignant cysts in postmenopausal women, especially for undetermined lesions.

Prospective external validation of IOTA three-step strategy for characterizing and classifying adnexal masses and retrospective assessment of alternative two-step strategy using simple-rules risk.

OBJECTIVES: To perform an external validation of the diagnostic performance of the three-step strategy proposed by the International Ovarian Tumor Analysis (IOTA) group for classifying adnexal masses as benign or malignant, when ultrasound is performed by non-expert sonographers in the first two steps. The second objective was to assess the diagnostic performance of an alternative strategy using simple-rules risk (SRR), instead of simple rules (SR), in the second step. METHODS: This was a prospective observational study conducted at two university hospitals, from September 2015 to August 2017, of consecutive patients diagnosed with an adnexal mass. All women were evaluated by ultrasound using the IOTA three-step strategy. Non-expert sonographers performed the first step (use of simple descriptors to classify the masses) and the second step (use of SR if the mass could not be classified in the first step); masses that could not be classified in the first two steps were categorized by an expert sonographer based on their subjective assessment (third step). The reference standard was histological diagnosis in patients who underwent surgery or at least 12 months of follow-up in cases managed expectantly. The sensitivity, specificity, positive (LR+) and negative (LR-) likelihood ratios and overall accuracy of the IOTA three-step strategy were estimated. Furthermore, we evaluated retrospectively an alternative two-step strategy using SRR in the second step to categorize the masses not classifiable with simple descriptors, classifying the lesions as being of low, intermediate or high risk for malignancy. The diagnostic performance of this strategy was estimated by calculating its sensitivity and specificity, assuming surgical intervention for intermediate- or high-risk lesions. RESULTS: The study included 283 patients (median age, 48 (range, 18-90) years), of whom 165 (58.3%) were premenopausal and 118 (41.7%) postmenopausal. Two hundred and sixteen (76.3%) women underwent surgery (154 benign and 62 malignant masses) and 67 (23.7%) were managed expectantly with serial ultrasound follow-up for at least 12 months. All expectantly managed masses were considered benign because no sonographic changes suggestive of malignancy were observed during follow-up. Simple descriptors could be applied in 126 (44.5%) masses. Of the remaining 157 lesions, 112 (39.6%) could be characterized using SR. Therefore, 238 (84.1%) masses could be classified by non-expert sonographers in the first two steps. Of the remaining 45 (15.9%) masses, all could be classified by an expert sonographer. Overall sensitivity, specificity, LR+ and LR- of the IOTA three-step strategy were 95.2%, 97.7%, 42.1 and 0.05, respectively. The diagnostic accuracy was 97.2%. Following the two-step strategy using SRR in the second step, of the 157 lesions not classified with simple descriptors, 42, 38 and 77 presented low, intermediate or high risk for malignancy, respectively. Based on this method, 210 women would have undergone surgical treatment. The sensitivity and specificity of this two-step strategy were 98.4% and 63.8%, respectively. CONCLUSIONS: The IOTA three-step strategy shows high accuracy for discriminating between benign and malignant adnexal lesions when used by non-expert sonographers. An alternative strategy using the SRR calculator in the second step might improve on this diagnostic performance by decreasing the number of surgical interventions and increasing sensitivity. Copyright © 2018 ISUOG. Published by John Wiley & Sons Ltd.

Diagnostic performance of the Gynecology Imaging Reporting and Data System for malignant adnexal masses.

OBJECTIVE: To evaluate the Gynecology Imaging Reporting and Data System (GI-RADS) for diagnosis of malignant adnexal masses in a Chinese population. METHODS: A retrospective study was conducted of patients who underwent evaluation of suspected adnexal masses at a hospital in Tianjin, China, between January 1, 2015, and January 31, 2016. Ultrasonographic diagnosis was based on the GI-RADS classification-a standardized summary of imaging data that estimates the risk of malignancy-and compared with the final pathological diagnosis. RESULTS: Among 242 patients, thick wall, solid papillary projection, solid area, central blood flow, ascites, and GI-RADS classification were associated with malignancy (P<0.05 for all variables). The 263 masses evaluated were classified as GI-RADS 2 (functional cyst; n=65), GI-RADS 3 (benign neoplasm; n=68), GI-RADS 4 (one or two morphological findings suggestive of malignancy; n=101), and GI-RADS 5 (≥3 morphological findings suggestive of malignancy; n=28). Four malignant cases with false-negative findings were misclassified as GI-RADS 3, whereas 24 benign cases with false-positive findings were misclassified as GI-RADS 4. The sensitivity, specificity, false-positive rate, false-negative rate, accuracy, and Youden index of the GI-RADS classification were 96.4%, 84.3%, 18.5%, 3.0%, 89.3%, and 80.7%, respectively. CONCLUSION: The GI-RADS classification performed well in the diagnosis of malignant adnexal masses.

Imaging of Adnexal Masses.

We review and emphasize the importance of gynecologic ultrasound scan for the preoperative evaluation of adnexal masses. Transvaginal ultrasound performed by a trained clinician has a good sensitivity and specificity for discriminating benign and malignant adnexal masses. In conjunction with a carefully obtained history, assessment of risk factors, a focused physical examination and serum markers, the information obtained by a gynecologic ultrasound evaluation can assist the clinician in the diagnosis and treatment of adnexal masses.

Clinical management of incidental findings on pelvic adnexal masses.

Due to widespread use of pelvic and transvaginal ultrasound in routine gynecological evaluation, the incidental finding of adnexal masses has led to discussions about management in asymptomatic patients regarding the risk of ovarian cancer. Transvaginal ultrasonography remains the modality of choice in the evaluation of suspicious characteristics. The combined analysis of ultrasound morphological parameters with Doppler study, serum carcinoma antigen 125 and investigation of a symptom index may improve diagnosis. Surgical approach should be considered whenever there are suspicious images, rapid growth of cysts, changes in the appearance compared to the initial evaluation or when the patient has symptoms. Future studies on genetic and molecular mechanisms may help explain the pathophysiology of ovarian cancer, improving early diagnosis and treatment.

Clinical management of incidental findings on pelvic adnexal masses / Manejo clínico dos achados incidentais de massas pélvicas anexiais

Summary Due to widespread use of pelvic and transvaginal ultrasound in routine gynecological evaluation, the incidental finding of adnexal masses has led to discussions about management in asymptomatic patients regarding the risk of ovarian cancer. Transvaginal ultrasonography remains the modality of choice in the evaluation of suspicious characteristics. The combined analysis of ultrasound morphological parameters with Doppler study, serum carcinona antigen 125 and investigation of a symptom index may improve diagnosis. Surgical approach should be considered whenever there are suspicious images, rapid growth of cysts, changes in the appearance compared to the initial evaluation or when the patient has symptoms. Future studies on genetic and molecular mechanisms may help explain the pathophysiology of ovarian cancer, improving early diagnosis and treatment.

Resumo Em virtude da ampla utilização da ultrassonografia pélvica e transvaginal na avaliação ginecológica de rotina, o achado incidental de massas anexiais tem ocasionado discussões sobre a conduta em pacientes assintomáticas frente ao risco de desenvolvimento do câncer de ovário. A ultrassonografia transvaginal continua a ser a modalidade de primeira escolha na avaliação de características suspeitas. A análise conjunta de parâmetros morfológicos ultrassonográficos com o estudo Doppler, a pesquisa de CA-125 e a investigação de índice de sintomas pode incrementar as taxas de diagnóstico. Abordagem cirúrgica deve ser considerada sempre que houver alterações em exames de imagem, quando houver crescimento rápido do cisto, mudanças em seu aspecto em relação à avaliação inicial ou quando a paciente apresentar sintomatologia. Uma compreensão melhor de mecanismos genéticos e moleculares pode auxiliar na elucidação da fisiopatologia do câncer ovariano, aprimorando seu diagnóstico e tratamento precoces.

Interobserver agreement in assigning IOTA color score to adnexal masses using three-dimensional volumes or digital videoclips: potential implications for training.

OBJECTIVE: To estimate the interobserver agreement between a trainer and trainees in assigning the International Ovarian Tumor Analysis (IOTA) color score to adnexal masses using three-dimensional (3D) volumes and videoclips. METHODS: Fifty-one digital videoclips and 3D volumes of a non-consecutive series of adnexal masses were used for this study. One trainer and four trainees evaluated first the 3D volume and 1 week later a videoclip from the same mass. They had to assign IOTA color scores according to their impression of the amount of color content in each case. Interobserver agreement between trainer and trainees was assessed using Cohen's weighted kappa index with 95% CIs and percentage of agreement. RESULTS: When using 3D volumes, interobserver agreement was good for three out of four pairs of comparisons and very good for one (kappa values of 0.70, 0.68, 0.81 and 0.71 for trainees A, B, C and D, respectively). When using videoclips, interobserver agreement was very good for two out of four pairs of comparisons and good for two (kappa values of 0.84, 0.80, 0.68 and 0.86 for Trainees A, B, C and D, respectively). CONCLUSION: Evaluation of IOTA color scores in adnexal masses using either videoclips or 3D volumes is reproducible even in the hands of trainees after a short training program.

[Fundamentals of cutaneous adnexal tumors]. / Basiswissen Hautadnextumoren.

Adnexal tumors of the skin are epithelial skin tumors with differentiation towards the adnexal epithelial structures of the skin, namely, hair follicle, sebaceous gland, apocrine gland, and eccrine gland. Adnexal tumors include hamartomas, benign and malignant neoplasms, and hyperplasias. The specific diagnosis of adnexal tumors is important because some lesions such as sebaceous neoplasms, cylindromas, or fibrofolliculomas are herald lesions of hereditary tumor syndromes (e.g., Muir-Torre syndrome, familial cylindromatosis, Birt-Hogg-Dubé syndrome). In this article, the classification of adnexal tumors of the skin is explained on the basis of embryology and histology and the main features of tumor-associated syndromes are summarized. Moreover, some conceptual controversies and problems in differential diagnosis of cutaneous adnexal tumors are discussed.

Interobserver agreement in describing adnexal masses using the International Ovarian Tumor Analysis simple rules in a real-time setting and using three-dimensional ultrasound volumes and digital clips.

OBJECTIVE: To estimate the agreement between an expert and a non-expert examiner using the International Ovarian Tumor Analysis (IOTA) simple rules for classifying adnexal masses on real-time ultrasound and when using three-dimensional (3D) ultrasound volumes and digital clips. METHODS: Forty-two non-consecutive women diagnosed as having an adnexal mass were evaluated by transvaginal power Doppler ultrasound as part of their diagnostic work-up. In each woman, examination was first performed by a non-expert examiner (a trainee) and immediately afterwards by an expert examiner. Both used the IOTA simple rules to describe the mass, blinded to each other's results. After finishing the examination, each examiner classified the mass as benign, malignant or inconclusive, according to the IOTA simple rules. Additionally, the expert recorded a short videoclip and acquired a static 3D volume of each mass, which were subsequently assessed by four trainees in obstetrics and gynecology with different levels of training, who also classified the mass as benign, malignant or inconclusive according to the IOTA simple rules. Agreement was assessed by calculating weighted and standard kappa index values with 95% CI and the percentage of agreement between observers. RESULTS: Agreement between the observers who performed real-time ultrasound examination was good (weighted kappa = 0.76; 95% CI, 0.61-0.90; agreement = 78.6%). Agreement between trainees using videoclips plus 3D volumes was moderate (kappa values ranged from 0.45 to 0.58, depending on pair comparison). CONCLUSION: Interobserver agreement of the IOTA simple rules for classifying adnexal masses as benign, malignant or inconclusive using real-time ultrasound, between an expert and a non-expert examiner, might be considered good. Agreement using a videoclip plus a 3D volume was moderate for trainees with different degrees of training.

Intra- and interobserver agreement with regard to describing adnexal masses using International Ovarian Tumor Analysis terminology: reproducibility study involving seven observers.

OBJECTIVES: To estimate intraobserver repeatability and interobserver agreement in assessing the presence of papillary projections in adnexal masses and in classifying adnexal masses using the International Ovarian Tumor Analysis terminology for ultrasound examiners with different levels of experience. We also aimed to identify ultrasound findings that cause confusion and might be interpreted differently by different observers, and to determine if repeatability and agreement change after consensus has been reached on how to interpret 'problematic' ultrasound images. METHODS: Digital clips (two to eight clips per adnexal mass) with gray-scale and color/power Doppler information of 83 adnexal masses in 80 patients were evaluated independently four times, twice before and twice after a consensus meeting, by four experienced and three less experienced ultrasound observers. The variables analyzed were tumor type (unilocular, unilocular solid, multilocular, multilocular solid, solid) and presence of papillary projections. Intraobserver repeatability was evaluated for each observer (percentage agreement, Cohen's kappa). Interobserver agreement was estimated for all seven observers (percentage agreement, Fleiss kappa, Cohen's kappa). RESULTS: There was uncertainty about how to define a solid component and a papillary projection, but consensus was reached at the consensus meeting. Interobserver agreement for tumor type was good both before and after the consensus meeting, with no clear improvement after the meeting, mean percentage agreement being 76.0% (Fleiss kappa, 0.695) before the meeting and 75.4% (Fleiss kappa, 0.682) after the meeting. Interobserver agreement with regard to papillary projections was moderate both before and after the consensus meeting, with no clear improvement after the meeting, mean percentage agreement being 86.6% (Fleiss kappa, 0.536) before the meeting and 82.7% (Fleiss kappa, 0.487) after it. There was substantial variability in pairwise agreement for papillary projections (Cohen's kappa, 0.148-0.787). Intraobserver repeatability with regard to tumor type was very good and similar before and after the consensus meeting (agreement 87-95%, kappa, 0.83-0.94). With regard to papillary projections intraobserver repeatability was good or very good both before and after the consensus meeting (agreement 88-100%, kappa, 0.64-1.0). CONCLUSIONS: Despite uncertainty about how to define solid components, interobserver agreement was good for tumor type. The interobserver agreement for papillary projection was moderate but very variable between observer pairs. The term 'papillary projection' might need a more precise definition. The consensus meeting did not change inter- or intraobserver agreement.

Sonographic discrimination between benign and malignant adnexal masses in premenopause.

PURPOSE: The aim of this study was to assess the diagnostic value of sonographic pattern recognition by experts, a standardized morphological scoring system, the risk malignancy index (RMI) and CA 125 assay for the preoperative assessment of ovarian lesions in premenopausal patients. MATERIAL AND METHODS: Diagnostic work-up of 1320 patients who underwent surgical exploration due to an adnexal mass at a tertiary referral center were included. We assessed the discriminative value of pattern recognition, a sonographic morphological scoring system, RMI and CA 125 by calculating sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and Cohen's kappa for each diagnostic approach while using histopathology as the reference standard. RESULTS: Pattern recognition showed the highest discriminative power with an observed kappa of 0.53. Sensitivity and specificity yielded 0.76 and 0.97 respectively. Combining pattern recognition with CA 125 serum measurement in the context of a triage system diminished the diagnostic value (kappa: 0.24; sensitivity: 0.29 specificity: 0.97). For the RMI we observed a sensitivity of 0.54 and a specificity of 0.96 and estimated kappa value yielded 0.37. Omitting the CA 125 assay and using a morphological sonographic assessment system increased the kappa value to 0.45 with sensitivity and specificity observed at 0.61 and 0.97 respectively. CONCLUSION: Expert pattern recognition was found to be the method with the highest discriminative power in assessing an adnexal mass during premenopause. Additional assessment of serum CA 125 diminished the diagnostic accuracy. Standardized morphological sonographic assessment resulted in a moderate diagnostic accuracy. Supplementing the morphological sonographic assessment with CA 125 by using the RMI algorithm did not improve the diagnostic value.

[Sonographic diagnosis of presumed benign ovarian tumors]. / Échographie et doppler dans le diagnostic des tumeurs ovariennes présumées bénignes.

To discriminate ovarian lesions is of particular importance in gynecological practice. Two main problems need answers: discrimination of benign and malignant adnexal masses and choice of the appropriate surgical treatment if necessary. Nearly 2% of the adnexal masses are ovarian carcinomas or borderline tumors. It is now, well established that ultrasonography is the gold standard for ovarian cyst diagnosis. The purpose of this data was to review the literature and to establish, with the evidence base medicine model, which parameters and existing diagnostic models using ultrasound and Doppler perform best in the evaluation of adnexal masses. Transvaginal sonography has demonstrated considerable advantage over conventional transabdominal sonography. However, transparietal sonography is still useful in large tumors. Definition of the nomenclature and classification was done and should be used. Unilocular ovarian cyst characterization seems easy using sonography and Doppler. In front of complication, discrimination of such functional cyst may be difficult but spontaneous regression confirms usually the expectative management. Dermoid cysts and endometriomas seem to be easier to discriminate from other adnexal masses. Ultrasound and morphologic parameters have a sensitivity of about 90% and a specificity of 80%; that makes this exam the gold standard for ovarian masses diagnosis. Only 50% of ovarian masses are characterized by sonography. Scoring systems help to differentiate benign from malignant masses (sensitivity of about 90%). Logistic regression and models are good methods especially for LR1 and 2 and RMI and may be useful for malignancy prediction but are difficult to use in current practice. Expert diagnosis is a subjective but most important performing parameter. Any suspicious ovarian mass or not easily diagnosed mass requires sonography by an expert, which can first use all the techniques and the different parameters to discriminate benign and malignant tumors. An explicit report will help the physician to define the right attitude for an appropriate management. Six to 16% of adnexial masses are complex or not classified and will result in MRI prescription or surgery.

[MRI and CT-scan in presumed benign ovarian tumors]. / IRM et TDM dans le diagnostic des tumeurs ovariennes présumées bénignes.

Radiological examinations are required for the assessment of complex or indeterminate ovarian masses, mainly using MRI and CT-scan. MRI provides better tissue characterization than Doppler ultrasound or CT-scan (LE2). Pelvic MRI is recommended in case of an indeterminate or complex ovarian ultrasonographic mass (grade B). The protocol of a pelvic MRI should include morphological T1 and T2 sequences (grade B). In case of solid portion, perfusion and diffusion sequences are recommended (grade C). In case of doubt about the diagnosis of ovarian origin, pelvic MRI is preferred over the CT-scan (grade C). MRI is the technique of choice for the difference between functional and organic ovarian lesion diagnosis (grade C). It can be useful in case of clinical diagnostic uncertainty between polycystic ovary syndrome and ovarian hyperstimulation and multilocular ovarian tumor syndrome (grade C). No MRI classification for ovarian masses is currently validated. The establishment of a presumption of risk of malignancy is required in a MRI report of adnexal mass with if possible a guidance on the histological diagnosis. In the absence of clinical or sonographic diagnosis, pelvic CT-scan is recommended in the context of acute painful pelvic mass in non-pregnant patients (grade C). It specifies the anomalies and allows the differential diagnosis with digestive and urinary diseases (LE4). Given the lack of data in the literature, the precautionary principle must be applied to the realization of a pelvic MRI in a pregnant patient. A risk-benefit balance should be evaluated case by case by the clinician and the radiologist and information should be given to the patient. In an emergency situation during pregnancy, pelvic MRI is an alternative to CT-scan for the exploration of acute pelvic pain in case of uncertain sonographic diagnosis (grade C).

Medical devices; immunology and microbiology devices; classification of ovarian adnexal mass assessment score test system. Final rule.

The Food and Drug Administration (FDA) is classifying the ovarian adnexal mass assessment score test system into class II (special controls). The special control that will apply to these devices is the guidance document entitled "Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Ovarian Adnexal Mass Assessment Score Test System." The Agency is classifying these devices into class II (special controls) because special controls, in addition to general controls, will provide a reasonable assurance of safety and effectiveness of these devices and there is sufficient information to establish special controls. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document that will serve as the special control for these devices

Improving the preoperative classification of adnexal masses as benign or malignant by second-stage tests.

OBJECTIVE: The aim of this study was to establish when a second-stage diagnostic test may be of value in cases where a primary diagnostic test has given an uncertain diagnosis of the benign or malignant nature of an adnexal mass. METHODS: The diagnostic performance with regard to discrimination between benign and malignant adnexal masses for mathematical models including ultrasound variables and for subjective evaluation of ultrasound findings by an experienced ultrasound examiner was expressed as area under the receiver-operating characteristics curve (AUC), sensitivity and specificity. These were calculated for the total study population of 1938 patients with an adnexal mass as well as for subpopulations defined by the certainty with which the diagnosis of benignity or malignancy was made. The effect of applying a second-stage test to the tumors where risk estimation was uncertain was determined. RESULTS: The best mathematical model (LR1) had an AUC of 0.95, sensitivity of 92% and specificity of 84% when applied to all tumors. When model LR1 was applied to the 10% of tumors in which the calculated risk fell closest to the risk cut-off of the model, the AUC was 0.59, sensitivity 90% and specificity 21%. A strategy where subjective evaluation was used to classify these 10% of tumors for which LR1 performed poorly and where LR1 was used in the other 90% of tumors resulted in a sensitivity of 91% and specificity of 90%. Applying subjective evaluation to all tumors yielded an AUC of 0.95, sensitivity of 90% and specificity of 93%. Sensitivity was 81% and specificity 47% for those patients where the ultrasound examiner was uncertain about the diagnosis (n = 115; 5.9%). No mathematical model performed better than did subjective evaluation among the 115 tumors where the ultrasound examiner was uncertain. CONCLUSION: When model LR1 is used as a primary test for discriminating between benign and malignant adnexal masses, the use of subjective evaluation of ultrasound findings by an experienced examiner as a second-stage test in the 10% of cases for which the model yields a risk of malignancy closest to its risk cut-off will improve specificity without substantially decreasing sensitivity. However, none of the models tested proved suitable as a second-stage test in tumors where subjective evaluation yielded an uncertain result.

Ultrasound for ovarian cancer screening: are we throwing the baby out with the bath water?

The lack of standardization in gynaecological scanning is worrying, especially with regard to the sonographic evaluation of adnexal masses. The results of ongoing trials on the use of ultrasound as a screening test for ovarian cancer are likely to be affected by this lack of standardization in terminology and classifications. The lack of high-quality gynaecological ultrasound, combined with the low prevalence of ovarian cancer, may yield to a poor performance of transvaginal ultrasound as a screening test for ovarian cancer in large trials. In order to increase the specificity of ultrasound in a screening program, thus reducing unnecessary surgeries, a uniform, reproducible and accurate method for the sonographic evaluation of ovarian masses must be implemented. This move to improve and standardize reporting in gynaecological ultrasound should negate the need to use the phrase 'complex ovarian mass'. In this paper, we will critically evaluate current terminology, newly proposed accepted morphological classification of ovarian cysts as well as the ability for ultrasound to discriminate between benign and malignant ovarian masses.