Patrícia Pinto

Patient satisfaction with ultrasound, whole-body CT and whole-body diffusion-weighted MRI for pre-operative ovarian cancer staging: a multicenter prospective cross-sectional survey

In addition to the diagnostic accuracy of imaging methods, patient-reported satisfaction with imaging methods is important. To report a secondary outcome of the prospective international multicenter Imaging Study in Advanced ovArian Cancer (ISAAC Study), detailing patients' experience with abdomino-pelvic ultrasound, whole-body contrast-enhanced computed tomography (CT), and whole-body diffusion-weighted magnetic resonance imaging (WB-DWI/MRI) for pre-operative ovarian cancer work-up. In total, 144 patients with suspected ovarian cancer at four institutions in two countries (Italy, Czech Republic) underwent ultrasound, CT, and WB-DWI/MRI for pre-operative work-up between January 2020 and November 2022. After having undergone all three examinations, the patients filled in a questionnaire evaluating their overall experience and experience in five domains: preparation before the examination, duration of examination, noise during the procedure, radiation load of CT, and surrounding space. Pain perception, examination-related patient-perceived unexpected, unpleasant, or dangerous events ('adverse events'), and preferred method were also noted. Ultrasound was the preferred method by 49% (70/144) of responders, followed by CT (38%, 55/144), and WB-DWI/MRI (13%, 19/144) (p7 of 10) during the ultrasound examination. We did not identify any factors related to patients' preferred method. Ultrasound was the imaging method preferred by most patients despite being associated with more pain during the examination in comparison with CT and WB-DWI/MRI. NCT03808792.

Ultrasound examiners' ability to describe ovarian cancer spread using preacquired ultrasound videoclips from a selected patient sample with high prevalence of cancer spread

ABSTRACTObjectivesTo assess the ability, as well as factors affecting the ability, of ultrasound examiners with different levels of ultrasound experience to detect correctly infiltration of ovarian cancer in predefined anatomical locations, and to evaluate the inter‐rater agreement regarding the presence or absence of cancer infiltration, using preacquired ultrasound videoclips obtained in a selected patient sample with a high prevalence of cancer spread.MethodsThis study forms part of the Imaging Study in Advanced ovArian Cancer multicenter observational study (NCT03808792). Ultrasound videoclips showing assessment of infiltration of ovarian cancer were obtained by the principal investigator (an ultrasound expert, who did not participate in rating) at 19 predefined anatomical sites in the abdomen and pelvis, including five sites that, if infiltrated, would indicate tumor non‐resectability. For each site, there were 10 videoclips showing cancer infiltration and 10 showing no cancer infiltration. The reference standard was either findings at surgery with histological confirmation or response to chemotherapy. For statistical analysis, the 19 sites were grouped into four anatomical regions: pelvis, middle abdomen, upper abdomen and lymph nodes. The videoclips were assessed by raters comprising both senior gynecologists (mainly self‐trained expert ultrasound examiners who perform preoperative ultrasound assessment of ovarian cancer spread almost daily) and gynecologists who had undergone a minimum of 6 months' supervised training in the preoperative ultrasound assessment of ovarian cancer spread in a gynecological oncology center. The raters were classified as highly experienced or less experienced based on annual individual caseload and the number of years that they had been performing ultrasound evaluation of ovarian cancer spread. Raters were aware that for each site there would be 10 videoclips with and 10 without cancer infiltration. Each rater independently classified every videoclip as showing or not showing cancer infiltration and rated the image quality (on a scale from 0 to 10) and their diagnostic confidence (on a scale from 0 to 10). A generalized linear mixed model with random effects was used to estimate which factors (including level of experience, image quality, diagnostic confidence and anatomical region) affected the likelihood of a correct classification of cancer infiltration. We assessed the observed percentage of videoclips classified correctly, the expected percentage of videoclips classified correctly based on the generalized linear mixed model and inter‐rater agreement (reliability) in classifying anatomical sites as being infiltrated by cancer.ResultsTwenty‐five raters participated in the study, of whom 13 were highly experienced and 12 were less experienced. The observed percentage of correct classification of cancer infiltration ranged from 70% to 100% depending on rater and anatomical site, and the median percentage of correct classification for the 25 raters ranged from 90% to 100%. The probability of correct classification of all 380 videoclips ranged from 0.956 to 0.975 and was not affected by the rater's level of ultrasound experience. The likelihood of correct classification increased with increased image quality and diagnostic confidence and was affected by anatomical region. It was highest for sites in the pelvis, second highest for those in the middle abdomen, third highest for lymph nodes and lowest for sites in the upper abdomen. The inter‐rater agreement of all 25 raters regarding the presence of cancer infiltration ranged from substantial (Fleiss kappa, 0.68 (95% CI, 0.66–0.71)) to very good (Fleiss kappa, 0.99 (95% CI, 0.97–1.00)) depending on the anatomical site. It was lowest for sites in the upper abdomen (Fleiss kappa, 0.68 (95% CI, 0.66–0.71) to 0.97 (95% CI, 0.94–0.99)) and highest for sites in the pelvis (Fleiss kappa, 0.94 (95% CI, 0.92–0.97) to 0.99 (95% CI, 0.97–1.00)).ConclusionsUltrasound examiners with different levels of ultrasound experience can classify correctly predefined anatomical sites as being infiltrated or not infiltrated by ovarian cancer based on video recordings obtained by an experienced ultrasound examiner, and the inter‐rater agreement is substantial. The likelihood of correct classification as well as the inter‐rater agreement is highest for sites in the pelvis and lowest for sites in the upper abdomen. However, owing to the study design, our results regarding diagnostic accuracy and inter‐rater agreement are likely to be overoptimistic. © 2025 The Author(s). Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of International Society of Ultrasound in Obstetrics and Gynecology.

Preoperative staging of ovarian cancer: comparison between ultrasound, CT and whole‐body diffusion‐weighted MRI (ISAAC study)

AbstractObjectivesTo compare the performance of transvaginal and transabdominal ultrasound with that of the first‐line staging method (contrast‐enhanced computed tomography (CT)) and a novel technique, whole‐body magnetic resonance imaging with diffusion‐weighted sequence (WB‐DWI/MRI), in the assessment of peritoneal involvement (carcinomatosis), lymph‐node staging and prediction of non‐resectability in patients with suspected ovarian cancer.MethodsBetween March 2016 and October 2017, all consecutive patients with suspicion of ovarian cancer and surgery planned at a gynecological oncology center underwent preoperative staging and prediction of non‐resectability with ultrasound, CT and WB‐DWI/MRI. The evaluation followed a single, predefined protocol, assessing peritoneal spread at 19 sites and lymph‐node metastasis at eight sites. The prediction of non‐resectability was based on abdominal markers. Findings were compared to the reference standard (surgical findings and outcome and histopathological evaluation).ResultsSixty‐seven patients with confirmed ovarian cancer were analyzed. Among them, 51 (76%) had advanced‐stage and 16 (24%) had early‐stage ovarian cancer. Diagnostic laparoscopy only was performed in 16% (11/67) of the cases and laparotomy in 84% (56/67), with no residual disease at the end of surgery in 68% (38/56), residual disease ≤ 1 cm in 16% (9/56) and residual disease > 1 cm in 16% (9/56). Ultrasound and WB‐DWI/MRI performed better than did CT in the assessment of overall peritoneal carcinomatosis (area under the receiver‐operating‐characteristics curve (AUC), 0.87, 0.86 and 0.77, respectively). Ultrasound was not inferior to CT (P = 0.002). For assessment of retroperitoneal lymph‐node staging (AUC, 0.72–0.76) and prediction of non‐resectability in the abdomen (AUC, 0.74–0.80), all three methods performed similarly. In general, ultrasound had higher or identical specificity to WB‐DWI/MRI and CT at each of the 19 peritoneal sites evaluated, but lower or equal sensitivity in the abdomen. Compared with WB‐DWI/MRI and CT, transvaginal ultrasound had higher accuracy (94% vs 91% and 85%, respectively) and sensitivity (94% vs 91% and 89%, respectively) in the detection of carcinomatosis in the pelvis. Better accuracy and sensitivity of ultrasound (93% and 100%) than WB‐DWI/MRI (83% and 75%) and CT (84% and 88%) in the evaluation of deep rectosigmoid wall infiltration, in particular, supports the potential role of ultrasound in planning rectosigmoid resection. In contrast, for the bowel serosal and mesenterial assessment, abdominal ultrasound had the lowest accuracy (70%, 78% and 79%, respectively) and sensitivity (42%, 65% and 65%, respectively).ConclusionsThis is the first prospective study to document that, in experienced hands, ultrasound may be an alternative to WB‐DWI/MRI and CT in ovarian cancer staging, including peritoneal and lymph‐node evaluation and prediction of non‐resectability based on abdominal markers of non‐resectability. © 2021 International Society of Ultrasound in Obstetrics and Gynecology.

Comparison of ultrasound with computed tomography and whole‐body diffusion‐weighted MRI in prediction of surgical outcome using ESMO ‐ ESGO criteria in patients with tubo‐ovarian carcinoma: prospective ISAAC study

ABSTRACT Objective To test the non‐inferiority of extended abdominopelvic ultrasound examination compared with contrast‐enhanced computed tomography (CT) and whole‐body diffusion‐weighted magnetic resonance imaging (WB‐DWI/MRI) in discriminating preoperatively between resectable and non‐resectable disease based on the European Society for Medical Oncology (ESMO) and European Society of Gynecological Oncology (ESGO)‐defined criteria in patients with tubo‐ovarian carcinoma. Methods The Imaging Study on Advanced ovArian Cancer was a prospective multicenter observational study conducted in five European gynecological oncology centers. All centers had ESGO accreditation to perform advanced ovarian cancer surgery, and ultrasound examinations were performed by a European Federation of Societies for Ultrasound in Medicine and Biology level‐III examiner in a standardized manner. Included in the analysis were patients enrolled between 2020 and 2022 with suspected or histologically proven primary tubo‐ovarian (including peritoneal) carcinoma who, for the purposes of the study, underwent ultrasound and CT imaging, as well as WB‐DWI/MRI if available, prior to surgery. The index tests, which included the preoperative imaging modalities as well as intraoperative exploration at the start of surgery, supplemented by biopsy or follow‐up imaging for extra‐abdominal locations, evaluated the presence of disease at eight anatomical sites that, if infiltrated, would indicate non‐resectability of the tumor according to the ESMO‐ESGO criteria. Surgical outcome, described by the surgeons at the end of the procedure, was used as the reference standard and non‐resectability was defined as the presence of residual disease > 1 cm or when debulking surgery was not feasible. The area under the receiver‐operating‐characteristics curve (AUC) and F 1  score were used to assess the performance of the preoperative imaging methods and surgical exploration in discriminating between patients with resectable and those with non‐resectable disease, based on the ESMO‐ESGO criteria. We also calculated the percentage agreement between imaging findings and surgical exploration findings at the start of surgery, supplemented when applicable by biopsy or follow‐up imaging for extra‐abdominal locations, regarding the presence of tumor infiltration at each of the eight anatomical sites associated with non‐resectability. Results Of 279 patients enrolled during the study period, 242 were included in the final analysis. In the subgroup of 167 patients who underwent surgery and had been examined by all three imaging methods, the AUC of the three imaging modalities and surgical exploration for discriminating between resectable and non‐resectable disease based on the ESMO‐ESGO criteria was 0.835 (95% CI, 0.756–0.915) for ultrasound, for CT it was 0.754 (95% CI, 0.664–0.843), for WB‐DWI/MRI it was 0.720 (95% CI, 0.626–0.814) and for surgical exploration it was 0.952 (95% CI, 0.915–0.988). Ultrasound was not inferior to CT or WB‐DWI/MRI, based on the AUC and F 1 score, in discriminating between patients with resectable and those with non‐resectable tubo‐ovarian carcinoma. At surgical exploration, at least one non‐resectability criterion was present in 32.2% cases. The criteria observed most frequently at surgical exploration were small‐bowel involvement (23.6% of cases), diffuse deep infiltration of the root of the small‐bowel mesentery (18.2% of cases) and hepatic hilum involvement (5.4% of cases). The percentage agreement between ultrasound and surgical exploration in assessing the presence of disease in at least one of the eight anatomical sites that, if infiltrated, would indicate non‐resectability of tumor, was 83.9%, surpassing the percentage agreement with surgical exploration of both CT (77.7%) and WB‐DWI/MRI (75.8%). Conclusion When performed by an experienced examiner, ultrasound is not inferior to either CT or WB‐DWI/MRI in discriminating between resectable and non‐resectable disease in patients with tubo‐ovarian carcinoma, based on evaluation of the presence of the disease in at least one of eight anatomical sites that, if infiltrated, would indicate non‐resectability of the tumor. © 2025 The Author(s). Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of International Society of Ultrasound in Obstetrics and Gynecology.

Prospective external validation of IOTA methods for classifying adnexal masses and retrospective assessment of two‐step strategy using benign descriptors and ADNEX model: Portuguese multicenter study

ABSTRACTObjectivesTo externally and prospectively validate the International Ovarian Tumor Analysis (IOTA) Simple Rules (SRs), Logistic Regression model 2 (LR2) and Assessment of Different NEoplasias in the adneXa (ADNEX) model in a Portuguese population, comparing these approaches with subjective assessment and the risk‐of‐malignancy index (RMI), as well as with each other. This study also aimed to retrospectively validate the IOTA two‐step strategy, using modified benign simple descriptors (MBDs) followed by the ADNEX model in cases in which MBDs were not applicable.MethodsThis was a prospective multicenter diagnostic accuracy study conducted between January 2016 and December 2021 of consecutive patients with an ultrasound diagnosis of at least one adnexal tumor, who underwent surgery at one of three tertiary referral centers in Lisbon, Portugal. All ultrasound assessments were performed by Level‐II or ‐III sonologists with IOTA certification. Patient clinical data and serum CA 125 levels were collected from hospital databases. Each adnexal mass was classified as benign or malignant using subjective assessment, RMI, IOTA SRs, LR2 and the ADNEX model (with and without CA 125). The reference standard was histopathological diagnosis. In the second phase, all adnexal tumors were classified retrospectively using the two‐step strategy (MBDs + ADNEX). Sensitivity, specificity, positive and negative predictive values, positive and negative likelihood ratios and overall accuracy were determined for all methods. Receiver‐operating‐characteristics curves were constructed and corresponding areas under the curve (AUC) were determined for RMI, LR2, the ADNEX model and the two‐step strategy. The ADNEX model calibration plots were constructed using locally estimated scatterplot smoothing (LOESS).ResultsOf the 571 patients included in the study, 428 had benign disease and 143 had malignant disease (prevalence of malignancy, 25.0%), of which 42 had borderline ovarian tumor, 93 had primary invasive adnexal cancer and eight had metastatic tumors in the adnexa. Subjective assessment had an overall sensitivity of 97.9% and a specificity of 83.6% for distinguishing between benign and malignant lesions. RMI showed high specificity (95.6%) but very low sensitivity (58.7%), with an AUC of 0.913. The IOTA SRs were applicable in 80.0% of patients, with a sensitivity of 94.8% and specificity of 98.6%. The IOTA LR2 had a sensitivity of 84.6%, specificity of 86.9% and an AUC of 0.939, at a malignancy risk cut‐off of 10%. At the same cut‐off, the sensitivity, specificity and AUC for the ADNEX model with vs without CA 125 were 95.8% vs 98.6%, 82.5% vs 79.7% and 0.962 vs 0.960, respectively. The ADNEX model gave heterogeneous results for distinguishing between benign masses and different subtypes of malignancy, with the highest AUC (0.991) for discriminating benign masses from primary invasive adnexal cancer Stages II–IV, and the lowest AUC (0.696) for discriminating primary invasive adnexal cancer Stage I from metastatic lesion in the adnexa. The calibration plot suggested underestimation of the risk by the ADNEX model compared with the observed proportion of malignancy. The MBDs were applicable in 26.3% (150/571) of cases, of which none was malignant. The two‐step strategy using the ADNEX model in the second step only, with and without CA 125, had AUCs of 0.964 and 0.961, respectively, which was similar to applying the ADNEX model in all patients.ConclusionsThe IOTA methods showed good‐to‐excellent performance in the Portuguese population, outperforming RMI. The ADNEX model was superior to other methods in terms of accuracy, but interpretation of its ability to distinguish between malignant subtypes was limited by sample size and large differences in the prevalence of tumor subtypes. The IOTA MBDs are reliable in identifying benign disease. The two‐step strategy comprising application of MBDs followed by the ADNEX model if MBDs are not applicable, is suitable for daily clinical practice, circumventing the need to calculate the risk of malignancy in all patients. © 2024 International Society of Ultrasound in Obstetrics and Gynecology.

Imaging Study in Advanced Ovarian Cancer

The aim of the study is the assessment of tumour sites critical for the achievement of optimal cytoreduction in patients with advanced ovarian cancer using Ultrasound, CT and WB-DWI/MRI. The study uses an equivalence design with a hypothesis that cases with non-resectable disease identified by Index test (Ultrasound, CT and WB-DWI MRI) are equivalent to a portion of cases identified during surgery.