| 1. |
- Froyman, Wouter, et al.
(författare)
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Risk of complications in patients with conservatively managed ovarian tumours (IOTA5) : a 2-year interim analysis of a multicentre, prospective, cohort study
- 2019
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Ingår i: The Lancet Oncology. - 1470-2045 .- 1474-5488. ; 20:3, s. 448-458
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Tidskriftsartikel (refereegranskat)abstract
- Background: Ovarian tumours are usually surgically removed because of the presumed risk of complications. Few large prospective studies on long-term follow-up of adnexal masses exist. We aimed to estimate the cumulative incidence of cyst complications and malignancy during the first 2 years of follow-up after adnexal masses have been classified as benign by use of ultrasonography. Methods: In the international, prospective, cohort International Ovarian Tumor Analysis Phase 5 (IOTA5) study, patients aged 18 years or older with at least one adnexal mass who had been selected for surgery or conservative management after ultrasound assessment were recruited consecutively from 36 cancer and non-cancer centres in 14 countries. Follow-up of patients managed conservatively is ongoing at present. In this 2-year interim analysis, we analysed patients who were selected for conservative management of an adnexal mass judged to be benign on ultrasound on the basis of subjective assessment of ultrasound images. Conservative management included ultrasound and clinical follow-up at intervals of 3 months and 6 months, and then every 12 months thereafter. The main outcomes of this 2-year interim analysis were cumulative incidence of spontaneous resolution of the mass, torsion or cyst rupture, or borderline or invasive malignancy confirmed surgically in patients with a newly diagnosed adnexal mass. IOTA5 is registered with ClinicalTrials.gov, number NCT01698632, and the central Ethics Committee and the Belgian Federal Agency for Medicines and Health Products, number S51375/B32220095331, and is ongoing. Findings: Between Jan 1, 2012, and March 1, 2015, 8519 patients were recruited to IOTA5. 3144 (37%) patients selected for conservative management were eligible for inclusion in our analysis, of whom 221 (7%) had no follow-up data and 336 (11%) were operated on before a planned follow-up scan was done. Of 2587 (82%) patients with follow-up data, 668 (26%) had a mass that was already in follow-up at recruitment, and 1919 (74%) presented with a new mass at recruitment (ie, not already in follow-up in the centre before recruitment). Median follow-up of patients with new masses was 27 months (IQR 14–38). The cumulative incidence of spontaneous resolution within 2 years of follow-up among those with a new mass at recruitment (n=1919) was 20·2% (95% CI 18·4–22·1), and of finding invasive malignancy at surgery was 0·4% (95% CI 0·1–0·6), 0·3% (<0·1–0·5) for a borderline tumour, 0·4% (0·1–0·7) for torsion, and 0·2% (<0·1–0·4) for cyst rupture. Interpretation: Our results suggest that the risk of malignancy and acute complications is low if adnexal masses with benign ultrasound morphology are managed conservatively, which could be of value when counselling patients, and supports conservative management of adnexal masses classified as benign by use of ultrasound. Funding: Research Foundation Flanders, KU Leuven, Swedish Research Council.
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| 2. |
- Moro, Francesca, et al.
(författare)
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Ultrasound evaluation of ovarian masses and assessment of the extension of ovarian malignancy
- 2021
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Ingår i: British Journal of Radiology. - : British Institute of Radiology. - 0007-1285 .- 1748-880X. ; 94:1125
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Forskningsöversikt (refereegranskat)abstract
- The current review sums up the literature on the diagnostic performance of models to predict malignancy in adnexal masses and the ability of ultrasound to make a specific diagnosis in adnexal masses. A summary of the role of ultrasound in assessing the extension of malignant ovarian disease is also provided.
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| 3. |
- Moro, Francesca, et al.
(författare)
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Ultrasound, macroscopic and histological features of malignant ovarian tumors
- 2021
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Ingår i: International Journal of Gynecological Cancer. - : BMJ. - 1048-891X .- 1525-1438. ; 31:1, s. 150-151
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Tidskriftsartikel (refereegranskat)abstract
- Ultrasound examination is considered to be the first line imaging method to diagnose an ovarian mass with a high degree of accuracy, discriminating between benign and malignant ovarian masses in the hands of experienced examiners. The International Ovarian Tumor Analysis (IOTA) group provided a standardized terminology of ovarian masses1 and suggested simple ultrasound rules that can be used to classify adnexal masses as benign or malignant.2 The IOTA group has also created logistic regression models (ie, ADNEX (Assessment of Different NEoplasias in the adneXa) model), including clinical and ultrasound information to calculate the likelihood of malignancy in adnexal masses. The IOTA ADNEX model estimates the likelihood not only of an adnexal mass being benign or malignant but also the likelihood that the mass is benign, borderline malignant, stage I primary invasive malignant, stage IIIV primary invasive malignant or a metastasis in the ovary from another primary tumor. 3 Recently, a consensus meeting including European and North American professionals developed a new risk model for the pre-operative assessment of adnexal masses, called O-RADS (Ovarian-Adnexal Reporting and Data System). The O-RADS ultrasound risk stratification and management system was designed to provide consistent interpretations, to decrease or eliminate ambiguity in ultrasound reports resulting in a higher probability of accuracy in assigning risk of malignancy to ovarian and other adnexal masses, and to provide a management recommendation for each risk category. 4 Moreover, during the past 15 years authors of the IOTA group have described the typical ultrasound appearance of several different adnexal pathologies, including various histotypes of malignancy, collected in the series of Imaging in gynecology papers. 510 Indeed, ovarian cancer includes several histological entities which can be grouped into four histological groups: epithelial tumors, germ cell tumors, stromal tumors and metastatic tumors. Each histopathological category is often characterized by some morphological typical features, as described in the textbooks of pathologists. In the pre-operative phase, ultrasound examination can enable assessment of these macroscopic aspects, thus providing a presumptive histological diagnosis. We present a video describing how to apply the simple ultrasound rules, the IOTA ADNEX model and the O-RADS model, and provides explanatory examples for each model.
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| 4. |
- Pinto, Patrícia, et al.
(författare)
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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
- 2024
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Ingår i: International Journal of Gynecological Cancer. - 1048-891X.
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Tidskriftsartikel (refereegranskat)abstract
- Background In addition to the diagnostic accuracy of imaging methods, patient-reported satisfaction with imaging methods is important. Objective 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. Methods 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. Results Ultrasound was the preferred method by 49% (70/144) of responders, followed by CT (38%, 55/144), and WB-DWI/MRI (13%, 19/144) (p<0.001). The poorest experience in all domains was reported for WB-DWI/ MRI, which was also associated with the largest number of patients who reported adverse events (eg, dyspnea). Patients reported higher levels of pain during the ultrasound examination than during CT and WB-DWI/MRI (p<0.001): 78% (112/144) reported no pain or mild pain, 19% (27/144) moderate pain, and 3% (5/144) reported severe pain (pain score >7 of 10) during the ultrasound examination. We did not identify any factors related to patients' preferred method.for diagnosing malignant ovarian tumors3 but has rarely been used for pre-operative ovarian cancer work-up.4–7 In 2022, the results of a prospective single-unit study indicated that ultrasound might be an alternative to CT and whole-body diffusion-weighted (WB-DWI)/ MRI for ovarian cancer work-up and prediction of tumor resectability.8 In the recently published European Society of Gynecological Oncology/European Society of Medical Oncology/European Society of Pathology (ESGO/ESMO/ESP) consensus conference recommendations on ovarian cancer, ultrasound is suggested to be an effective alternative to CT, MRI and PET-CT to assess tumor extent and tumor resectability in the pelvis and abdomen.2 In addition to diagnostic accuracy and costs of an imaging method, patient acceptance and preference are important before an imaging test is implemented in clinical practice.9 10 Although there is evidence regarding patients’ experience of and satisfaction with ultrasound,11 12 CT,13–17 and WB-DWI/MRI,16 18–20 little is known about how these three imaging modalities compare when applied in the same patient. Many factors can influence a patient’s experience with an imaging examination—for example, preparation for, and duration of, the examination; use of contrast agent (especially iodinated contrast agent); radiation dose (which depends on the duration of radiation exposure, distance from the radiation source, and physical shielding); noise, feeling of claustrophobia, and occurrence of unexpected unpleasant or dangerous events (adverse events).21–25 The aim of this study is to report a secondary outcome of the prospective, multicentric Imaging Study in Advanced ovArian Cancer (ISAAC Study)—namely, patients’ experience with ultrasound, CT, and WB-DWI/MRI for pre-operative estimation of the extent of ovarian cancer.
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| 5. |
- Timmerman, Dirk, et al.
(författare)
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Simple ultrasound rules to distinguish between benign and malignant adnexal masses before surgery: prospective validation by IOTA group
- 2010
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Ingår i: BMJ: British Medical Journal. - : BMJ. - 1756-1833. ; 341, s. 6839-6839
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Tidskriftsartikel (refereegranskat)abstract
- Objectives To prospectively assess the diagnostic performance of simple ultrasound rules to predict benignity/malignancy in an adnexal mass and to test the performance of the risk of malignancy index, two logistic regression models, and subjective assessment of ultrasonic findings by an experienced ultrasound examiner in adnexal masses for which the simple rules yield an inconclusive result. Design Prospective temporal and external validation of simple ultrasound rules to distinguish benign from malignant adnexal masses. The rules comprised five ultrasonic features (including shape, size, solidity, and results of colour Doppler examination) to predict a malignant tumour (M features) and five to predict a benign tumour (B features). If one or more M features were present in the absence of a B feature, the mass was classified as malignant. If one or more B features were present in the absence of an M feature, it was classified as benign. If both M features and B features were present, or if none of the features was present, the simple rules were inconclusive. Setting 19 ultrasound centres in eight countries. Participants 1938 women with an adnexal mass examined with ultrasound by the principal investigator at each centre with a standardised research protocol. Reference standard Histological classification of the excised adnexal mass as benign or malignant. Main outcome measures Diagnostic sensitivity and specificity. Results Of the 1938 patients with an adnexal mass, 1396 (72%) had benign tumours, 373 (19.2%) had primary invasive tumours, 111 (5.7%) had borderline malignant tumours, and 58 (3%) had metastatic tumours in the ovary. The simple rules yielded a conclusive result in 1501 (77%) masses, for which they resulted in a sensitivity of 92% (95% confidence interval 89% to 94%) and a specificity of 96% (94% to 97%). The corresponding sensitivity and specificity of subjective assessment were 91% (88% to 94%) and 96% (94% to 97%). In the 357 masses for which the simple rules yielded an inconclusive result and with available results of CA-125 measurements, the sensitivities were 89% (83% to 93%) for subjective assessment, 50% (42% to 58%) for the risk of malignancy index, 89% (83% to 93%) for logistic regression model 1, and 82% (75% to 87%) for logistic regression model 2; the corresponding specificities were 78% (72% to 83%), 84% (78% to 88%), 44% (38% to 51%), and 48% (42% to 55%). Use of the simple rules as a triage test and subjective assessment for those masses for which the simple rules yielded an inconclusive result gave a sensitivity of 91% (88% to 93%) and a specificity of 93% (91% to 94%), compared with a sensitivity of 90% (88% to 93%) and a specificity of 93% (91% to 94%) when subjective assessment was used in all masses. Conclusions The use of the simple rules has the potential to improve the management of women with adnexal masses. In adnexal masses for which the rules yielded an inconclusive result, subjective assessment of ultrasonic findings by an experienced ultrasound examiner was the most accurate diagnostic test; the risk of malignancy index and the two regression models were not useful.
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| 6. |
- Van Calster, Ben, et al.
(författare)
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A Novel Approach to Predict the Likelihood of Specific Ovarian Tumor Pathology Based on Serum CA-125: A Multicenter Observational Study.
- 2011
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Ingår i: Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology. - 1538-7755. ; 20, s. 2420-2428
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND: The CA-125 tumor marker has limitations when used to distinguish between benign and malignant ovarian masses. We therefore establish likelihood curves of six subgroups of ovarian pathology based on CA-125 and menopausal status.METHODS: This cross-sectional study conducted by the International Ovarian Tumor Analysis group involved 3,511 patients presenting with a persistent adnexal mass that underwent surgical intervention. CA-125 distributions for six tumor subgroups (endometriomas and abscesses, other benign tumors, borderline tumors, stage I invasive cancers, stage II-IV invasive cancers, and metastatic tumors) were estimated using kernel density estimation with stratification for menopausal status. Likelihood curves for the tumor subgroups were derived from the distributions.RESULTS: Endometriomas and abscesses were the only benign pathologies with median CA-125 levels above 20 U/mL (43 and 45, respectively). Borderline and invasive stage I tumors had relatively low median CA-125 levels (29 and 81 U/mL, respectively). The CA-125 distributions of stage II-IV invasive cancers and benign tumors other than endometriomas or abscesses were well separated; the distributions of the other subgroups overlapped substantially. This held for premenopausal and postmenopausal patients. Likelihood curves and reference tables comprehensibly show how subgroup likelihoods change with CA-125 and menopausal status.Conclusions and Impact: Our results confirm the limited clinical value of CA-125 for preoperative discrimination between benign and malignant ovarian pathology. We have shown that CA-125 may be used in a different way. By using likelihood reference tables, we believe clinicians will be better able to interpret preoperative serum CA-125 results in patients with adnexal masses. Cancer Epidemiol Biomarkers Prev; ©2011 AACR.
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| 7. |
- Van Calster, Ben, et al.
(författare)
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Discrimination between benign and malignant adnexal masses by specialist ultrasound examination versus serum CA-125
- 2007
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Ingår i: Journal of the National Cancer Institute. - : Oxford University Press (OUP). - 1460-2105 .- 0027-8874. ; 99:22, s. 1706-1714
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Tidskriftsartikel (refereegranskat)abstract
- Background Subjective evaluation of gray-scale and Doppler ultrasound findings (i. e., pattern recognition) by an experienced examiner and preoperative serum levels of CA-125 can both discriminate benign from malignant adnexal ( i. e., ovarian, paraovarian, or tubal) masses. We compared the diagnostic performance of these methods in a large multicenter study. Methods In a prospective multicenter study-the International Ovarian Tumor Analysis-1066 women with a persistent adnexal mass underwent transvaginal gray-scale and color Doppler ultrasound examinations by an experienced examiner within 120 days of surgery. Pattern recognition was used to classify a mass as benign or malignant. Of these women, 809 also had blood collected preoperatively for measurement of serum CA-125. Various levels of CA-125 were used as cutoffs to classify masses. Results from both assays were then compared with histologic findings after surgery. Results Pattern recognition correctly classified 93% (95% confidence interval [CI]=90.9% to 94.6%) of the tumors as benign or malignant. Serum CA-125 correctly classified at best 83% ( 95% CI=80.3% to 85.6%) of the masses. Histologic diagnoses that were most often misclassified by CA-125 were fibroma, endometrioma, and abscess ( false-positive results) and borderline tumor ( false-negative results). Pattern recognition correctly classified 86% ( 95% CI=81.1% to 90.4%) of masses of these four histologic types as being benign or malignant, whereas a serum CA-125 at a cutoff of 30 U/mL correctly classified 41% ( 95% CI=34.4% to 47.5%) of them. Pattern recognition assigned a correct specific histologic diagnosis to 333 (59%, 95% CI=54.5% to 62.8%) of the 567 benign lesions. Conclusion Pattern recognition was superior to serum CA-125 for discrimination between benign and malignant adnexal masses.
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