ACR Appropriateness Criteria® Clinically Suspected Adnexal Mass, No Acute Symptoms: 2023 Update.

Asymptomatic adnexal masses are commonly encountered in daily radiology practice. Although the vast majority of these masses are benign, a small subset have a risk of malignancy, which require gynecologic oncology referral for best treatment outcomes. Ultrasound, using a combination of both transabdominal, transvaginal, and duplex Doppler technique can accurately characterize the majority of these lesions. MRI with and without contrast is a useful complementary modality that can help characterize indeterminate lesions and assess the risk of malignancy is those that are suspicious. The American College of Radiology Appropriateness Criteria are evidence-based guidelines for specific clinical conditions that are reviewed annually by a multidisciplinary expert panel. The guideline development and revision process support the systematic analysis of the medical literature from peer reviewed journals. Established methodology principles such as Grading of Recommendations Assessment, Development, and Evaluation or GRADE are adapted to evaluate the evidence. The RAND/UCLA Appropriateness Method User Manual provides the methodology to determine the appropriateness of imaging and treatment procedures for specific clinical scenarios. In those instances where peer reviewed literature is lacking or equivocal, experts may be the primary evidentiary source available to formulate a recommendation.

O-RADS US v2022: An Update from the American College of Radiology's Ovarian-Adnexal Reporting and Data System US Committee.

First published in 2019, the Ovarian-Adnexal Reporting and Data System (O-RADS) US provides a standardized lexicon for ovarian and adnexal lesions, enables stratification of these lesions with use of a numeric score based on morphologic features to indicate the risk of malignancy, and offers management guidance. This risk stratification system has subsequently been validated in retrospective studies and has yielded good interreader concordance, even with users of different levels of expertise. As use of the system increased, it was recognized that an update was needed to address certain clinical challenges, clarify recommendations, and incorporate emerging data from validation studies. Additional morphologic features that favor benignity, such as the bilocular feature for cysts without solid components and shadowing for solid lesions with smooth contours, were added to O-RADS US for optimal risk-appropriate scoring. As O-RADS US 4 has been shown to be an appropriate cutoff for malignancy, it is now recommended that lower-risk O-RADS US 3 lesions be followed with US if not excised. For solid lesions and cystic lesions with solid components, further characterization with MRI is now emphasized as a supplemental evaluation method, as MRI may provide higher specificity. This statement summarizes the updates to the governing concepts, lexicon terminology and assessment categories, and management recommendations found in the 2022 version of O-RADS US.

The Ovarian/Adnexal Reporting and Data System for Ultrasound: From Standardized Terminology to Optimal Risk Assessment and Management.

The American College of Radiology (ACR) Ovarian-Adnexal Reporting and Data System (O-RADS) lexicon and risk assessment tool for ultrasound (US) provides a framework for characterization of ovarian and adnexal pathology with the ultimate goal of harmonizing reporting and patient management strategies. Since the first O-RADS US publication in 2018, multiple validation studies have shown O-RADS US to have excellent diagnostic accuracy, with the majority of these studies using O-RADS 4 as the optimal cut-off for detecting ovarian cancer. Most of the existing validation studies include a dedicated training phase and confirm that ORADS US categories and lexicon descriptors are associated with high level inter-read agreement, regardless of radiologist training level or practice experience. O-RADS US has a similar inter-reader agreement when compared to Gynecologic Imaging Reporting and Data System (GIRADS), Assessment of Different Neoplasias in the adnexa (ADNEX), and International Tumor Analysis Group (IOTA) simple rules. System descriptors have been shown to correlate with expected malignancy rates and the O-RADS US risk stratification system has been shown to perform in the expected range of malignancy risk per category. Further directions will focus on clarifying governing concepts and lexicon terminology as well as further refining risk stratification categories based on data from published validation studies.

External Validation of the Ovarian-Adnexal Reporting and Data System (O-RADS) Lexicon and the International Ovarian Tumor Analysis 2-Step Strategy to Stratify Ovarian Tumors Into O-RADS Risk Groups.

Importance: Correct diagnosis of ovarian cancer results in better prognosis. Adnexal lesions can be stratified into the Ovarian-Adnexal Reporting and Data System (O-RADS) risk of malignancy categories with either the O-RADS lexicon, proposed by the American College of Radiology, or the International Ovarian Tumor Analysis (IOTA) 2-step strategy. Objective: To investigate the diagnostic performance of the O-RADS lexicon and the IOTA 2-step strategy. Design, Setting, and Participants: Retrospective external diagnostic validation study based on interim data of IOTA5, a prospective international multicenter cohort study, in 36 oncology referral centers or other types of centers. A total of 8519 consecutive adult patients presenting with an adnexal mass between January 1, 2012, and March 1, 2015, and treated either with surgery or conservatively were included in this diagnostic study. Twenty-five patients were excluded for withdrawal of consent, 2777 were excluded from 19 centers that did not meet predefined data quality criteria, and 812 were excluded because they were already in follow-up at recruitment. The analysis included 4905 patients with a newly detected adnexal mass in 17 centers that met predefined data quality criteria. Data were analyzed from January 31 to March 1, 2022. Exposures: Stratification into O-RADS categories (malignancy risk <1%, 1% to <10%, 10% to <50%, and ≥50%). For the IOTA 2-step strategy, the stratification is based on the individual risk of malignancy calculated with the IOTA 2-step strategy. Main Outcomes and Measures: Observed prevalence of malignancy in each O-RADS risk category, as well as sensitivity and specificity. The reference standard was the status of the tumor at inclusion, determined by histology or clinical and ultrasonographic follow-up for 1 year. Multiple imputation was used for uncertain outcomes owing to inconclusive follow-up information. Results: Median age of the 4905 patients was 48 years (IQR, 36-62 years). Data on race and ethnicity were not collected. A total of 3441 tumors (70%) were benign, 978 (20%) were malignant, and 486 (10%) had uncertain classification. Using the O-RADS lexicon resulted in 1.1% (24 of 2196) observed prevalence of malignancy in O-RADS 2, 4% (34 of 857) in O-RADS 3, 27% (246 of 904) in O-RADS 4, and 78% (732 of 939) in O-RADS 5; the corresponding results for the IOTA 2-step strategy were 0.9% (18 of 1984), 4% (58 of 1304), 30% (206 of 690), and 82% (756 of 927). At the 10% risk threshold (O-RADS 4-5), the O-RADS lexicon had 92% sensitivity (95% CI, 87%-96%) and 80% specificity (95% CI, 74%-85%), and the IOTA 2-step strategy had 91% sensitivity (95% CI, 84%-95%) and 85% specificity (95% CI, 80%-88%). Conclusions and Relevance: The findings of this external diagnostic validation study suggest that both the O-RADS lexicon and the IOTA 2-step strategy can be used to stratify patients into risk groups. However, the observed malignancy rate in O-RADS 2 was not clearly below 1%.

Ovarian-Adnexal Reporting Lexicon for MRI: A White Paper of the ACR Ovarian-Adnexal Reporting and Data Systems MRI Committee.

MRI is used in the evaluation of ovarian and adnexal lesions. MRI can further characterize lesions seen on ultrasound to help decrease the number of false-positive lesions and avoid unnecessary surgery in benign lesions. Currently, the reporting of ovarian and adnexal findings on MRI is inconsistent because of the lack of standardized descriptor terminology. The development of uniform reporting descriptors can lead to improved interpretation agreement and communication between radiologists and referring physicians. The Ovarian-Adnexal Reporting and Data Systems MRI Committee was formed under the direction of the ACR to create a standardized lexicon for adnexal lesions with the goal of improving the quality and consistency of imaging reports. This white paper describes the consensus process in the creation of a standardized lexicon for ovarian and adnexal lesions for MRI and the resultant lexicon.

O-RADS for Ultrasound: A User's Guide, From the AJR Special Series on Radiology Reporting and Data Systems.

The Ovarian-Adnexal Reporting and Data System (O-RADS) is a lexicon and risk stratification tool designed for the accurate characterization of adnexal lesions and is essential for optimal patient management. O-RADS is a recent addition to the American College of Radiology (ACR) reporting and data systems and consists of ultrasound (US) and MRI arms. Since most ovarian or adnexal lesions are first detected with US, O-RADS US is considered the primary assessment tool. Application of O-RADS US is recommended whenever a nonphysiologic lesion is encountered. Lesion characterization may be streamlined by use of an algorithmic approach focused on relevant features and an abbreviated version of the lexicon. Resources to expedite O-RADS US categorization and determination of a management recommendation include easy online access to the ACR color-coded risk stratification scorecards and an O-RADS US calculator that is available as a smartphone app. Reporting should be concise and include relevant features for risk stratification that adhere to lexicon terminology. Technical considerations include optimization of gray-scale and color Doppler technique and performance of problem-solving maneuvers to help avoid common pitfalls. This review provides a user-friendly summary of O-RADS US with practical tips for everyday clinical use.

O-RADS US Risk Stratification and Management System: A Consensus Guideline from the ACR Ovarian-Adnexal Reporting and Data System Committee.

The Ovarian-Adnexal Reporting and Data System (O-RADS) US risk stratification and management system is designed to provide consistent interpretations, to decrease or eliminate ambiguity in US 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. It was developed by an international multidisciplinary committee sponsored by the American College of Radiology and applies the standardized reporting tool for US based on the 2018 published lexicon of the O-RADS US working group. For risk stratification, the O-RADS US system recommends six categories (O-RADS 0-5), incorporating the range of normal to high risk of malignancy. This unique system represents a collaboration between the pattern-based approach commonly used in North America and the widely used, European-based, algorithmic-style International Ovarian Tumor Analysis (IOTA) Assessment of Different Neoplasias in the Adnexa model system, a risk prediction model that has undergone successful prospective and external validation. The pattern approach relies on a subgroup of the most predictive descriptors in the lexicon based on a retrospective review of evidence prospectively obtained in the IOTA phase 1-3 prospective studies and other supporting studies that assist in differentiating management schemes in a variety of almost certainly benign lesions. With O-RADS US working group consensus, guidelines for management in the different risk categories are proposed. Both systems have been stratified to reach the same risk categories and management strategies regardless of which is initially used. At this time, O-RADS US is the only lexicon and classification system that encompasses all risk categories with their associated management schemes.

Simple Adnexal Cysts: SRU Consensus Conference Update on Follow-up and Reporting.

This multidisciplinary consensus update aligns prior Society of Radiologists in Ultrasound (SRU) guidelines on simple adnexal cysts with recent large studies showing exceptionally low risk of cancer associated with simple adnexal cysts. Most small simple cysts do not require follow-up. For larger simple cysts or less well-characterized cysts, follow-up or second opinion US help to ensure that solid elements are not missed and are also useful for assessing growth of benign tumors. In postmenopausal women, reporting of simple cysts greater than 1 cm should be done to document their presence in the medical record, but such findings are common and follow-up is recommended only for simple cysts greater than 3-5 cm, with the higher 5-cm threshold reserved for simple cysts with excellent imaging characterization and documentation. For simple cysts in premenopausal women, these thresholds are 3 cm for reporting and greater than 5-7 cm for follow-up imaging. If a cyst is at least 10%-15% smaller at any time, then further follow-up is unnecessary. Stable simple cysts at initial follow-up may benefit from a follow-up at 2 years due to measurement variability that could mask growth. Simple cysts that grow are likely cystadenomas. If a previously suspected simple cyst demonstrates papillary projections or solid areas at follow-up, then the cyst should be described by using standardized terminology. These updated SRU consensus recommendations apply to asymptomatic patients and to those whose symptoms are not clearly attributable to the cyst. These recommendations can reassure physicians and patients regarding the benign nature of simple adnexal cysts after a diagnostic-quality US examination that allows for confident diagnosis of a simple cyst. Patients will benefit from less costly follow-up, less anxiety related to these simple cysts, and less surgery for benign lesions.

Ovarian-Adnexal Reporting Lexicon for Ultrasound: A White Paper of the ACR Ovarian-Adnexal Reporting and Data System Committee.

Ultrasound is the most commonly used imaging technique for the evaluation of ovarian and other adnexal lesions. The interpretation of sonographic findings is variable because of inconsistency in descriptor terminology used among reporting clinicians. The use of vague terms that are inconsistently applied can lead to significant differences in interpretation and subsequent management strategies. A committee was formed under the direction of the ACR initially to create a standardized lexicon for ovarian lesions with the goal of improving the quality and communication of imaging reports between ultrasound examiners and referring clinicians. The ultimate objective will be to apply the lexicon to a risk stratification classification for consistent follow-up and management in clinical practice. This white paper describes the consensus process in the creation of a standardized lexicon for ovarian and adnexal lesions and the resultant lexicon.

Use of the thyroid imaging, reporting, and data system (TI-RADS) scoring system for the evaluation of subcentimeter thyroid nodules.

BACKGROUND: The American Thyroid Association (ATA) recommends fine-needle aspiration (FNA) biopsy of nodules measuring >1.5 cm with low-suspicion sonographic patterns or >1.0 cm with high/intermediate-suspicion features. Routine biopsy of nodules <1 cm is not recommended. However, despite these recommendations, subcentimeter nodules are often referred for FNA biopsy. METHODS: This was a retrospective chart review of consecutive thyroid FNAs during an 18-month period (1157 patients, 1491 nodules, 2016-2017) to evaluate age, sex, medical history, diagnoses, and follow-up. Radiographic information was used to identify 61 subcentimeter nodules (4%) from 57 patients. Ultrasound studies were re-evaluated using criteria according to the American College of Radiology Thyroid Imaging, Reporting, and Data System (TI-RADS). RESULTS: Reported reasons for biopsy included a larger companion nodule (44%), a personal or family history of cancer (26%), or a suspicious sonogram, including calcification and/or irregular contours (16%). FNA diagnoses included: 69% benign (42 of 61 nodules), 10% papillary thyroid carcinoma (PTC) (6 of 61 nodules), and 15% atypia of undetermined significance/follicular lesion of undetermined significance (AUS/FLUS) (9 of 61 nodules). Seven percent of nodules were unsatisfactory/nondiagnostic (4 of 61 nodules) compared with a 3% nondiagnostic rate for all sized nodules. Fifty-one nodules had an ultrasound available for re-review using the TI-RADS scoring system. A high TI-RADS score (4-5) was indicative of PTC in 29.4% of nodules. A low TI-RADS score (1-2) was indicative of PTC in 0% of nodules (P < .01). High and intermediate TI-RADS scores (3 and 4-5, respectively) were indicative of PTC/AUS/FLUS in 32% of nodules compared with 0% in those with low TI-RADS scores (P < .01). CONCLUSIONS: The current results demonstrate successful use of the TI-RADS scoring system in evaluation of the risk of malignancy in subcentimeter nodules. Larger studies will be necessary to determine whether biopsy is warranted for TI-RADS high-subcentimeter nodules. Cancer Cytopathol 2018. © 2018 American Cancer Society.

Sonography of Responsive Versus Nonresponsive Ectopic Pregnancies.

This case series describes changes in size, vascularity, and cul-de-sac fluid in 30 patients with ectopic pregnancies who were treated with systemic methotrexate. Pretreatment and posttreatment transvaginal sonography of the ectopic pregnancies was performed with color Doppler imaging, and the images were assessed for changes in size, vascularity, and cul-de-sac free fluid. There was a trend for nonresponders to show increased vascularity on serial examinations, although this finding was also seen in a single responder. There was also a trend for nonresponders with increased vascularity to be associated with a greater increase in ß-human chorionic gonadotropin levels and responders with decreased vascularity to be associated with a greater decrease in ß-human chorionic gonadotropin levels.

Practical applications of 3D sonography in gynecologic imaging.

Volume imaging in the pelvis has been well demonstrated to be an extremely useful technique, largely based on its ability to reconstruct the coronal plane of the uterus that usually cannot be visualized using traditional 2-dimensional (2D) imaging. As a result, this technique is now a part of the standard pelvic ultrasound protocol in many institutions. A variety of valuable applications of 3D sonography in the pelvis are discussed in this article.

Two-/three-dimensional transperineal sonography of complicated tape and mesh implants.

Transperineal sonography (TPS) affords dynamic evaluation of suburethral slings using tensionless vaginal tape and mesh implants used to treat complications associated with surgical procedures of the pelvic floor. This review describes and illustrates the TPS findings in postoperative complications such as recurrent prolapse, cystocele, enterocele, and rectocele. The potential use of live 3-dimensional TPS to delineate the dynamics aspects of pelvic floor disorder is also mentioned.

ACR Appropriateness Criteria® pretreatment planning of invasive cancer of the cervix.

The prognosis of cervical cancer is linked to lymph node involvement, and this is predicted clinically and pathologically by the stage of the disease, as well as the volume and grade of the tumor. Staging of cervical cancer based on International Federation of Gynecology and Obstetrics (FIGO) staging uses physical examination, cystoscopy, proctoscopy, intravenous urography, and barium enema. It does not include CT or MRI. Evaluation of the parametrium is limited in FIGO staging, and lymph node metastasis, an important prognostic factor, is not included in FIGO staging. The most important role for imaging is to distinguish stages Ia, Ib, and IIa disease treated with surgery from advanced disease treated with radiation therapy with or without chemotherapy. This article reviews the current role of imaging in pretreatment planning of invasive cervical cancer. The ACR Appropriateness Criteria(®) are evidence-based guidelines for specific clinical conditions that are reviewed every 2 years by a multidisciplinary expert panel. The guideline development and review include an extensive analysis of current medical literature from peer-reviewed journals and the application of a well-established consensus methodology (modified Delphi) to rate the appropriateness of imaging and treatment procedures by the panel. In those instances in which evidence is lacking or not definitive, expert opinion may be used to recommend imaging or treatment.

ACR appropriateness criteria(®) on abnormal vaginal bleeding.

In evaluating a woman with abnormal vaginal bleeding, imaging cannot replace definitive histologic diagnosis but often plays an important role in screening, characterization of structural abnormalities, and directing appropriate patient care. Transvaginal ultrasound (TVUS) is generally the initial imaging modality of choice, with endometrial thickness a well-established predictor of endometrial disease in postmenopausal women. Endometrial thickness measurements of ≤5 mm and ≤4 mm have been advocated as appropriate upper threshold values to reasonably exclude endometrial carcinoma in postmenopausal women with vaginal bleeding; however, the best upper threshold endometrial thickness in the asymptomatic postmenopausal patient remains a subject of debate. Endometrial thickness in a premenopausal patient is a less reliable indicator of endometrial pathology since this may vary widely depending on the phase of menstrual cycle, and an upper threshold value for normal has not been well-established. Transabdominal ultrasound is generally an adjunct to TVUS and is most helpful when TVUS is not feasible or there is poor visualization of the endometrium. Hysterosonography may also allow for better delineation of both the endometrium and focal abnormalities in the endometrial cavity, leading to hysteroscopically directed biopsy or resection. Color and pulsed Doppler may provide additional characterization of a focal endometrial abnormality by demonstrating vascularity. MRI may also serve as an important problem-solving tool if the endometrium cannot be visualized on TVUS and hysterosonography is not possible, as well as for pretreatment planning of patients with suspected endometrial carcinoma. CT is generally not warranted for the evaluation of patients with abnormal bleeding, and an abnormal endometrium incidentally detected on CT should be further evaluated with TVUS.

ACR appropriateness Criteria® pretreatment evaluation and follow-up of endometrial cancer of the uterus.

Endometrial cancer is one of the common malignancies in the female genital tract. Imaging in pretreatment evaluation may play an important role in an assessment of morphological prognostic factors including tumor size, depth of myometrial invasion, endocervical extent, and lymph node status. Imaging is also useful in posttreatment evaluation of patients with clinically suspected recurrence. Various modalities including MRI, CT ultrasound and FDG PET-CT-CT have been used for evaluation of the endometrial cancer in both before and after treatment settings. Literature on the indications and usefulness of these imaging studies for endometrial cancer is reviewed.

ACR appropriateness criteria© ovarian cancer screening.

The majority of women with ovarian cancer have advanced stage disease at the time of diagnosis and a poor 5 year survival rate. Hence, screening has been investigated in the hopes of improving survival by diagnosing ovarian cancer at an earlier stage. Most screening methods thus far have included ultrasound and/or serum tumor markers. However, low prevalence of the disease, high false positive rate of current screening methods, and the probable rapid growth of most ovarian carcinomas from no defined precursor lesion, all contribute to difficulty in screening for ovarian cancer. While screening may be able to detect ovarian cancer at an earlier stage, adequate data is presently lacking on whether screening improves survival. The results of ongoing large clinical trials will be available in a few years and should provide critical information regarding the usefulness of screening. Pending results of those large clinical trials, screening is not currently recommended for women at average risk for ovarian cancer. Screening is most likely to be performed in women with an increased familial risk of ovarian cancer, but patients should be aware that even with this risk factor, there is currently insufficient evidence to know if screening is effective. New screening methods, including new or multiple serum markers and proteomics, are also being investigated.