Part II: Effect of different evaluation methods to the application of a computer-aided prostate MRI detection/diagnosis (CADe/CADx) device on reader performance.

INTRODUCTION: The construction and results of a multiple-reader multiple-case prostate MRI study are described and reported to illustrate recommendations for how to standardize artificial intelligence (AI) prostate studies per the review constituting Part I1. METHODS: Our previously reported approach was applied to review and report an IRB approved, HIPAA compliant multiple-reader multiple-case clinical study of 150 bi-parametric prostate MRI studies across 9 readers, measuring physician performance both with and without the use of the recently FDA cleared CADe/CADx software ProstatID. RESULTS: Unassisted reader AUC values ranged from 0.418 - 0.759, with AI assisted AUC values ranging from 0.507 - 0.787. This represented a statistically significant AUC improvement of 0.045 (α = 0.05). A free-response ROC (FROC) analysis similarly demonstrated a statistically significant increase in θ from 0.405 to 0.453 (α = 0.05). The standalone performance of ProstatID performed across all prostate tissues demonstrated an AUC of 0.929, while the standalone lesion level performance of ProstatID at all biopsied locations achieved an AUC of 0.710. CONCLUSION: This study applies and illustrates suggested reporting and standardization methods for prostate AI studies that will make it easier to understand, evaluate and compare between AI studies. Providing radiologists with the ProstatID CADe/CADx software significantly increased diagnostic performance as assessed by both ROC and free-response ROC metrics. Such algorithms have the potential to improve radiologist performance in the detection and localization of clinically significant prostate cancer.

Part I: prostate cancer detection, artificial intelligence for prostate cancer and how we measure diagnostic performance: a comprehensive review.

MRI has firmly established itself as a mainstay for the detection, staging and surveillance of prostate cancer. Despite its success, prostate MRI continues to suffer from poor inter-reader variability and a low positive predictive value. The recent emergence of Artificial Intelligence (AI) to potentially improve diagnostic performance shows great potential. Understanding and interpreting the AI landscape as well as ever-increasing research literature, however, is difficult. This is in part due to widely varying study design and reporting techniques. This paper aims to address this need by first outlining the different types of AI used for the detection and diagnosis of prostate cancer, next deciphering how data collection methods, statistical analysis metrics (such as ROC and FROC analysis) and end points/outcomes (lesion detection vs. case diagnosis) affect the performance and limit the ability to compare between studies. Finally, this work explores the need for appropriately enriched investigational datasets and proper ground truth, and provides guidance on how to best conduct AI prostate MRI studies. Published in parallel, a clinical study applying this suggested study design was applied to review and report a multiple-reader multiple-case clinical study of 150 bi-parametric prostate MRI studies across nine readers, measuring physician performance both with and without the use of a recently FDA cleared Artificial Intelligence software.1.

Statin therapy in patients with early-stage autosomal dominant polycystic kidney disease: Design and baseline characteristics.

BACKGROUND: Autosomal dominant polycystic kidney disease (ADPKD) is characterized by the development and continued growth of multiple cysts in the kidneys leading to ultimate loss of kidney function in most patients. Currently, tolvaptan is the only agency approved therapy to slow kidney disease advancement in patients with faster progressing disease underscoring the need for additional ADPKD therapies suitable for all patients. We previously showed that pravastatin slowed kidney disease progression in children and young adults with ADPKD. However, the intervention has not been tested in an adult cohort. AIMS: The aim of the study is to conduct a single center, randomized, placebo-controlled double-blinded clinical trial to determine the efficacy of pravastatin on slowing kidney disease progression in adult patients with early stage ADPKD. METHODS: One hundred and fifty adult patients with ADPKD and eGFR ≥60 ml/min/1.73m2 will be enrolled in the study and randomized to receive 40 mg/day pravastatin or placebo for a period of 2-years. OUTCOMES: The primary outcome of the trial is change in total kidney volume assessed by magnetic resonance imaging (MRI). Secondary outcomes include change in kidney function by iothalamate GFR and renal blood flow and markers of inflammation and oxidative stress. CONCLUSION: This study will assess the kidney therapeutic benefits of pravastatin in adult patients with ADPKD. The recruitment goal of 150 subjects was attained and the study is ongoing. REGISTRATION: This study is registered on Clinicaltrials.gov # NCT03273413.

Use of Imaging and Biopsy in Prostate Cancer Diagnosis: A Survey From the Asian Prostate Imaging Working Group.

OBJECTIVE: To elucidate the use of radiological studies, including nuclear medicine, and biopsy for the diagnosis and staging of prostate cancer (PCA) in clinical practice and understand the current status of PCA in Asian countries via an international survey. MATERIALS AND METHODS: The Asian Prostate Imaging Working Group designed a survey questionnaire with four domains focused on prostate magnetic resonance imaging (MRI), other prostate imaging, prostate biopsy, and PCA backgrounds. The questionnaire was sent to 111 members of professional affiliations in Korea, Japan, Singapore, and Taiwan who were representatives of their working hospitals, and their responses were analyzed. RESULTS: This survey had a response rate of 97.3% (108/111). The rates of using 3T scanners, antispasmodic agents, laxative drugs, and prostate imaging-reporting and data system reporting for prostate MRI were 21.6%-78.9%, 22.2%-84.2%, 2.3%-26.3%, and 59.5%-100%, respectively. Respondents reported using the highest b-values of 800-2000 sec/mm² and fields of view of 9-30 cm. The prostate MRI examinations per month ranged from 1 to 600, and they were most commonly indicated for biopsy-naïve patients suspected of PCA in Japan and Singapore and staging of proven PCA in Korea and Taiwan. The most commonly used radiotracers for prostate positron emission tomography are prostate-specific membrane antigen in Singapore and fluorodeoxyglucose in three other countries. The most common timing for prostate MRI was before biopsy (29.9%). Prostate-targeted biopsies were performed in 63.8% of hospitals, usually by MRI-ultrasound fusion approach. The most common presentation was localized PCA in all four countries, and it was usually treated with radical prostatectomy. CONCLUSION: This survey showed the diverse technical details and the availability of imaging and biopsy in the evaluation of PCA. This suggests the need for an educational program for Asian radiologists to promote standardized evidence-based imaging approaches for the diagnosis and staging of PCA.

Clinical Outcomes in Patients Receiving Originator Follitropin Alfa and Follitropin Alfa Biosimilars in Real-world Clinical Practice: A Retrospective Study.

Background: Biosimilar drugs have broadened the treatment options in assisted reproductive technology (ART). Real-world data comparing clinical outcomes of originator follitropin alfa (Gonal-f®) with its biosimilars are required to enrich the body of evidence for clinical decision-making on choice of drug. Aims: To compare the ART outcomes in patients receiving originator follitropin (Gonal-f®) and its biosimilars in clinical setting. Settings and Design: Medical records of 364 infertile women who underwent ART between 2016 and 2020 at Akanksha Hospital and Research Institute, Gujrat, India, were retrospectively analysed. Materials and Methods: Participants were divided into two cohorts based on treatment (Gonal-f® cohort; N = 174 and biosimilar cohort; N = 190), each cohort further subdivided into group A (age <35 years) and group B (age ≥35 years). Fresh or frozen embryo transfer was performed as per the standard procedures of the clinic. Pregnancy rates and live birth rate (LBR) were the primary main outcome measures in this study. Statistical Analysis Used: Descriptive statistics and Chi-square test were used for analysis. Results: The number of oocytes retrieved from Gonal-f® and biosimilar cohorts were comparable (13.3 vs. 14.4). Compared to biosimilars, Gonal-f® treatment resulted in higher yield of cleavage stage and blastocyst stage embryos, and the proportion of women with good quality embryos was higher in the Gonal-f® cohort than the biosimilar cohort (83.3% vs. 69.5%). Patients receiving Gonal-f® reported higher pregnancy rates (59.2% vs. 39.7%) and LBR (43% vs. 17.7%) compared to those receiving biosimilars. Conclusions: Gonal-f® (originator follitropin) treatment could result in higher pregnancy rates and LBR in comparison to biosimilars in real-world setting.

Sodium Bicarbonate Treatment and Vascular Function in CKD: A Randomized, Double-Blind, Placebo-Controlled Trial.

SIGNIFICANCE STATEMENT: Lower serum bicarbonate levels, even within the normal range, are strongly linked to risks of cardiovascular disease in CKD, possibly by modifying vascular function. In this randomized, controlled trial, treatment with sodium bicarbonate (NaHCO 3 ) did not improve vascular endothelial function or reduce arterial stiffness in participants with CKD stage 3b-4 with normal serum bicarbonate levels. In addition, NaHCO 3 treatment did not reduce left ventricular mass index. NaHCO 3 did increase plasma bicarbonate levels and urinary citrate excretion and reduce urinary ammonium excretion, indicating that the intervention was indeed effective. NaHCO 3 therapy was safe with no significant changes in BP, weight, or edema. These results do not support the use of NaHCO 3 for vascular dysfunction in participants with CKD. BACKGROUND: Lower serum bicarbonate levels, even within the normal range, are strongly linked to risks of cardiovascular disease in CKD, possibly by modifying vascular function. Prospective interventional trials with sodium bicarbonate (NaHCO 3 ) are lacking. METHODS: We conducted a randomized, double-blind, placebo-controlled trial examining the effect of NaHCO 3 on vascular function in 109 patients with CKD stage 3b-4 (eGFR 15-44 ml/min per 1.73 m 2 ) with normal serum bicarbonate levels (22-27 mEq/L). Participants were randomized 1:1 to NaHCO 3 or placebo at a dose of 0.5 mEq/lean body weight-kg per day for 12 months. The coprimary end points were change in brachial artery flow-mediated dilation (FMD) and change in aortic pulse wave velocity over 12 months. RESULTS: Ninety patients completed this study. After 12 months, plasma bicarbonate levels increased significantly in the NaHCO 3 group compared with placebo (mean [SD] difference between groups 1.35±2.1, P = 0.003). NaHCO 3 treatment did not result in a significant improvement in aortic pulse wave velocity from baseline. NaHCO 3 did result in a significant increase in flow-mediated dilation after 1 month; however, this effect disappeared at 6 and 12 months. NaHCO 3 resulted in a significant increase in 24-hour urine citrate and pH and a significant decrease in 24-hour urine ammonia. There was no significant change in left ventricular mass index, ejection fraction, or eGFR with NaHCO 3 . NaHCO 3 treatment was safe and well-tolerated with no significant changes in BP, antihypertensive medication, weight, plasma calcium, or potassium levels. CONCLUSION: Our results do not support the use of NaHCO 3 for vascular dysfunction in participants with CKD and normal serum bicarbonate levels.

Adenocarcinoma of the uterine cervix, gastric-type (GAS): a review of the literature focused on pathology and multimodality imaging.

Adenocarcinoma of the uterine cervix, gastric-type (GAS) is a rare, well-differentiated subtype of HPV-independent endocervical adenocarcinoma. It classically arises in middle-aged women with symptoms, including profuse watery vaginal discharge and abnormal uterine bleeding. Given the rarity of this disease, misdiagnosis is common and prognosis remains poorly defined. Distinct pathology and imaging findings can aid in diagnosis. A literature review was performed to ascertain recurring pathologic and radiologic characteristics of GAS. Key pathologic features of GAS include cytologically benign appearing mucinous glands that infiltrate into the deep stroma and may demonstrate lymphovascular or perineural invasion. Multiple imaging modalities including transvaginal ultrasound, CT, and MRI may aid in diagnosis of GAS, which characteristically is seen as a multicystic mass with solid components. MRI in particular is the preferred imaging study because it offers the best chance of identifying a potential solid component, which is key to making the diagnosis of GAS and distinguishing it from other endocervical diseases processes. Careful attention to histopathologic and radiologic details, in conjunction with clinical correlation, is necessary to distinguish GAS from other multicystic cervical lesions.

Curcumin Therapy to Treat Vascular Dysfunction in Children and Young Adults with ADPKD: A Randomized Controlled Trial.

BACKGROUND AND OBJECTIVES: Clinical manifestations of autosomal dominant polycystic kidney disease (ADPKD), including evidence of vascular dysfunction, can begin in childhood. Curcumin is a polyphenol found in turmeric that reduces vascular dysfunction in rodent models and humans without ADPKD. It also slows kidney cystic progression in a murine model of ADPKD. We hypothesized that oral curcumin therapy would reduce vascular endothelial dysfunction and arterial stiffness in children/young adults with ADPKD. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: In a randomized, placebo-controlled, double-blind trial, 68 children/young adults 6-25 years of age with ADPKD and eGFR>80 ml/min per 1.73 m2 were randomized to either curcumin supplementation (25 mg/kg body weight per day) or placebo administered in powder form for 12 months. The coprimary outcomes were brachial artery flow-mediated dilation and aortic pulse-wave velocity. We also assessed change in circulating/urine biomarkers of oxidative stress/inflammation and kidney growth (height-adjusted total kidney volume) by magnetic resonance imaging. In a subgroup of participants ≥18 years, vascular oxidative stress was measured as the change in brachial artery flow-mediated dilation following an acute infusion of ascorbic acid. RESULTS: Enrolled participants were 18±5 (mean ± SD) years, 54% were girls, baseline brachial artery flow-mediated dilation was 9.3±4.1% change, and baseline aortic pulse-wave velocity was 512±94 cm/s. Fifty-seven participants completed the trial. Neither coprimary end point changed with curcumin (estimated change [95% confidence interval] for brachial artery flow-mediated dilation [percentage change]: curcumin: 1.14; 95% confidence interval, -0.84 to 3.13; placebo: 0.33; 95% confidence interval, -1.34 to 2.00; estimated difference for change: 0.81; 95% confidence interval, -1.21 to 2.84; P=0.48; aortic pulse-wave velocity [centimeters per second]: curcumin: 0.6; 95% confidence interval, -25.7 to 26.9; placebo: 6.5; 95% confidence interval, -20.4 to 33.5; estimated difference for change: -5.9; 95% confidence interval, -35.8 to 24.0; P=0.67; intent to treat). There was no curcumin-specific reduction in vascular oxidative stress or changes in mechanistic biomarkers. Height-adjusted total kidney volume also did not change as compared with placebo. CONCLUSIONS: Curcumin supplementation does not improve vascular function or slow kidney growth in children/young adults with ADPKD. CLINICAL TRIAL REGISTRY NAME AND REGISTRATION NUMBER: Curcumin Therapy to Treat Vascular Dysfunction in Children and Young Adults with ADPKD, NCT02494141. PODCAST: This article contains a podcast at https://www.asn-online.org/media/podcast/CJASN/2022_02_07_CJN08950621.mp3.

Birth of a healthy infant after bone marrow-derived cell therapy.

Bone marrow-derived cell (BMDC) therapy has numerous applications as potential biological cells for use in regenerative medicine. Here, we present an original case of endometrial atrophy associated with genital tuberculosis in a woman who achieved a live birth with BMDC. This 27-year-old woman came to our center with endometrial atrophy and primary infertility. She had a past history of genital tuberculosis and amenorrhea. Her husband's semen quality was normal. The patient was counseled for hysteroscopy due to thin endometrium and advised in vitro fertilization (IVF) with donor eggs in lieu of poor ovarian reserve. Several attempts of IVF with hormone replacement therapy (HRT) were made, but the desired thickness of the endometrium was not achieved. Uterine artery injection of BMDC through interventional radiology was given, followed by HRT for three months, which resulted in improved endometrium. This was subsequently followed by IVF with donor egg. The treatment resulted in the conception and delivery of a 3.1-kg baby boy through lower segment caesarean section with no antenatal, intranatal or postnatal complications. Recently, there has been massive interest in stem cells as a novel treatment method for regenerative medicine, and more specifically for the regeneration of human endometrium disorders like Asherman syndrome and thin endometrium, which was the reason behind using this strategy for treatment.

Translabial Ultrasound for Assessment of Synthetic Midurethral Sling Complications.

ABSTRACT: Translabial ultrasound (TLUS) is an inexpensive, noninvasive imaging modality traditionally used for assessment of pelvic organ prolapse. The utility of TLUS has recently been expanded to the evaluation of synthetic midurethral slings (MUS) surgically implanted for management of stress urinary incontinence. The purpose of this article is to familiarize radiologists with translabial ultrasound technique and provide a technical protocol for TLUS execution because it can be optimized for imaging and assessment of MUS, including identification of MUS configuration and recognition of common complications. This article provides example images of transobturator and retropubic slings and their associated complications, as visualized on TLUS. Accurate imaging and assessment of MUS is helpful in the evaluation of the patient presenting with symptoms suspicious for sling-related complications and in the planning of surgical revision.

Clinical Importance of Incidental Homogeneous Renal Masses That Measure 10-40 mm and 21-39 HU at Portal Venous Phase CT: A 12-Institution Retrospective Cohort Study.

BACKGROUND. Incidental homogeneous renal masses are frequently encountered at portal venous phase CT. The American College of Radiology Incidental Findings Committee's white paper on renal masses recommends additional imaging for incidental homogeneous renal masses greater than 20 HU, but single-center data and the Bosniak classification version 2019 suggest the optimal attenuation threshold for detecting solid masses should be higher. OBJECTIVE. The purpose of this article is to determine the clinical importance of small (10-40 mm) incidentally detected homogeneous renal masses measuring 21-39 HU at portal venous phase CT. METHODS. We performed a 12-institution retrospective cohort study of adult patients who underwent portal venous phase CT for a nonrenal indication. The date of the first CT at each institution ranged from January 1, 2008, to January 1, 2014. Consecutive reports from 12,167 portal venous phase CT examinations were evaluated. Images were reviewed for 4529 CT examinations whose report described a focal renal mass. Eligible masses were 10-40 mm, well-defined, subjectively homogeneous, and 21-39 HU. Of these, masses that were shown to be solid without macroscopic fat; classified as Bosniak IIF, III, or IV; or confirmed to be malignant were considered clinically important. The reference standard was renal mass protocol CT or MRI, ultrasound of definitively benign cysts or solid masses, single-phase contrast-enhanced CT or unenhanced MRI showing no growth or morphologic change for 5 years or more, or clinical follow-up 5 years or greater. A reference standard was available for 346 masses in 300 patients. The 95% CIs were calculated using the binomial exact method. RESULTS. Eligible masses were identified in 4.2% of patients (514/12,167; 95% CI, 3.9-4.6%). Of 346 masses with a reference standard, none were clinically important (0%; 95% CI, 0-0.9%). Mean mass size was 17 mm; 72% (248/346) measured 21-30 HU, and 28% (98/346) measured 31-39 HU. CONCLUSION. Incidental small homogeneous renal masses measuring 21-39 HU at portal venous phase CT are common and highly likely benign. CLINICAL IMPACT. The change in attenuation threshold signifying the need for additional imaging from greater than 20 HU to greater than 30 HU proposed by the Bosniak classification version 2019 is supported.

Drug-free In vitro Activation for Primary Ovarian Insufficiency.

Primary Ovarian Insufficiency (POI) or Diminished Ovarian Reserve (DOR) are the two conditions that affects women leading to infertility due to the lack of follicular growth and ovulation. Egg / Oocyte donation remains an option for these patients. However, with the development in Reproductive medicine various novel technologies like Ovarian Cryopreservation, Fragmentation, in vitro activation with drug treatment or even drug free autotransplantation enables the possibility of activating the pool of primordial follicles that can lead to successful pregnancy outcomes. Here, we report a case of women with POI, in which drug free in vitro activation of follicles was performed, followed by autotransplantation, which resulted in successful pregnancy. This is first case report from India that shows the procedure works and can be tried for women with POI.

A Successful Case for Deselection of Albino Embryo and Live Birth of Albinism-Free Healthy Baby Followed by PGT-M.

In recent years, Preimplantation genetic testing for monogenic disorders (PGT-M) has gained a lot of focus in the field of assisted reproduction technology, various studies have been published in support of it and many are opposing its role. It has been criticized due to many ethical as well as scientific reasons, but there is no doubt that PGT-M has been one of the most important breakthroughs in in vitro fertilization. A critical aspect of this technology is the possibility that the biopsy itself can adversely affect the quality of embryo and compulsion of embryo freezing. Oculocutaneous albinism (OCA) is a condition which is related to skin, hair, eye color (pigments), where affected individuals typically have very fair skin and white- or light-colored hair. These patients are prone to skin cancers on prolonged sun exposure. It also reduces the pigmentation of the colored part of the eyes (the iris) and the light-sensitive tissue at the back of the eye (the retina). People with this condition usually have problem in vision such as reduced sharpness, involuntary eye movements, and photophobia. Here, we report the successful use of PGT-M and a novel protocol for the preimplantation genetic diagnosis of OCA following trophectoderm cell biopsy from blastocysts and the birth of a healthy infant to a couple having previously affected child.

Tips to start an MR-US fusion biopsy program.

There is growing evidence that MRI-ultrasound (MR-US)-targeted biopsy (TB) has high detection rates of clinically significant prostate cancer (PCa) compared to standard transrectal ultrasound (TRUS)-guided biopsy. A radiologist plays a significant role in MR-US fusion biopsy planning. Here, we discuss six simple steps that can help set up a successful MR-US fusion biopsy program in collaboration with the urologist.

Variability of the Positive Predictive Value of PI-RADS for Prostate MRI across 26 Centers: Experience of the Society of Abdominal Radiology Prostate Cancer Disease-focused Panel.

Background Prostate MRI is used widely in clinical care for guiding tissue sampling, active surveillance, and staging. The Prostate Imaging Reporting and Data System (PI-RADS) helps provide a standardized probabilistic approach for identifying clinically significant prostate cancer. Despite widespread use, the variability in performance of prostate MRI across practices remains unknown. Purpose To estimate the positive predictive value (PPV) of PI-RADS for the detection of high-grade prostate cancer across imaging centers. Materials and Methods This retrospective cross-sectional study was compliant with the HIPAA. Twenty-six centers with members in the Society of Abdominal Radiology Prostate Cancer Disease-focused Panel submitted data from men with suspected or biopsy-proven untreated prostate cancer. MRI scans were obtained between January 2015 and April 2018. This was followed with targeted biopsy. Only men with at least one MRI lesion assigned a PI-RADS score of 2-5 were included. Outcome was prostate cancer with Gleason score (GS) greater than or equal to 3+4 (International Society of Urological Pathology grade group ≥2). A mixed-model logistic regression with institution and individuals as random effects was used to estimate overall PPVs. The variability of observed PPV of PI-RADS across imaging centers was described by using the median and interquartile range. Results The authors evaluated 3449 men (mean age, 65 years ± 8 [standard deviation]) with 5082 lesions. Biopsy results showed 1698 cancers with GS greater than or equal to 3+4 (International Society of Urological Pathology grade group ≥2) in 2082 men. Across all centers, the estimated PPV was 35% (95% confidence interval [CI]: 27%, 43%) for a PI-RADS score greater than or equal to 3 and 49% (95% CI: 40%, 58%) for a PI-RADS score greater than or equal to 4. The interquartile ranges of PPV at these same PI-RADS score thresholds were 27%-44% and 27%-48%, respectively. Conclusion The positive predictive value of the Prostate Imaging and Reporting Data System was low and varied widely across centers. © RSNA, 2020 Online supplemental material is available for this article. See also the editorial by Milot in this issue.

Mineralocorticoid Antagonism and Vascular Function in Early Autosomal Dominant Polycystic Kidney Disease: A Randomized Controlled Trial.

RATIONALE & OBJECTIVE: Vascular dysfunction, characterized by impaired vascular endothelial function and increased large-elastic artery stiffness, is evident early in autosomal dominant polycystic kidney disease (ADPKD) and is an important predictor of cardiovascular events and mortality. Aldosterone excess has been implicated in the development of endothelial dysfunction and arterial stiffness, in part by causing increased oxidative stress and inflammation. We hypothesized that aldosterone antagonism would reduce vascular dysfunction in patients with early-stage ADPKD. STUDY DESIGN: Prospective, randomized, controlled, double-blind, clinical trial. SETTING & PARTICIPANTS: 61 adults aged 20 to 55 years with ADPKD, estimated glomerular filtration rate ≥ 60mL/min/1.73m2, and receiving a renin-angiotensin-aldosterone system inhibitor. INTERVENTION: Spironolactone (maximum dose, 50mg/d) or placebo for 24 weeks. OUTCOMES: Change in brachial artery flow-mediated dilation (FMDBA) was the primary end point and change in carotid-femoral pulse-wave velocity (CFPWV) was the secondary end point. RESULTS: 60 participants completed the trial. Participants had a mean age of 34±10 (SD) years, 54% were women, and 84% were non-Hispanic white. Spironolactone did not change FMDBA (8.0% ± 5.5% and 7.8% ± 4.3% at baseline and 24 weeks, respectively, vs corresponding values in the placebo group of 8.4% ± 6.2% and 8.0% ± 4.6%; P=0.9for comparison of change between groups) or CFPWV (640±127 and 603±101cm/s at baseline and 24 weeks, respectively, vs corresponding values in the placebo group of 659±138 and 658±131cm/s; P=0.1). Brachial systolic blood pressure was reduced with spironolactone (median change, -6 [IQR, -15, 1] vs -2 [IQR, -7, 10] mm Hg in the placebo group; P=0.04). Spironolactone did not change the majority of circulating and/or endothelial cell markers of oxidative stress/inflammation and did not change vascular oxidative stress. LIMITATIONS: Low level of baseline vascular dysfunction; lack of aldosterone measurements. CONCLUSIONS: 24 weeks of aldosterone antagonism reduced systolic blood pressure without changing vascular function in patients with early-stage ADPKD. FUNDING: NIDDK, NIH National Center for Advancing Translational Sciences, and the Zell Family Foundation. TRIAL REGISTRATION: Registered at ClinicalTrials.gov with study number NCT01853553.

Risk Threshold Algorithm for Thyroid Nodule Management Demonstrates Increased Specificity and Diagnostic Accuracy as Compared With American College of Radiology Thyroid Imaging, Reporting and Data System; Society of Radiologists in Ultrasound; and American Thyroid Association Management Guidelines.

We studied diagnostic performance of an algorithm guiding thyroid nodule management using a malignancy risk model as compared with extant management guidelines. Single-institution, retrospective study was performed with sequential cases from pathology registry from 2012 to 2015. Seventy-eight patients were enrolled, with benign and malignant groups defined by aspiration results. Risk Threshold Algorithm determined management based off of a logistic regression model and a risk threshold. American College of Radiology Thyroid Imaging, Reporting and Data System (ACR TI-RADS), Society of Radiologists in Ultrasound (SRU), and American Thyroid Association (ATA) guidelines were used in comparison. Sensitivity, specificity, positive/negative predictive values, receiver operating characteristic (ROC) values were derived, with significance assessed via McNemar and permutation tests. Forty-four benign nodules and 40 papillary thyroid carcinomas were included. Risk Threshold Algorithm area under the ROC curve was 0.80 versus 0.59 (ACR TI-RADS), 0.49 (SRU), and 0.44 (ATA); all areas under the ROC curve differences were statistically significant. Risk Threshold Algorithm demonstrates sensitivity, specificity, positive predictive value, and negative predictive values of 63%, 91%, 86%, and 73% at the risk threshold maximizing diagnostic performance, compared with 85%, 39%, 56%, and 74% (ACR TI-RADS); 85%, 18%, 50%, and 57% (SRU); and 89%, 11%, 50%, and 83% (ATA). Sensitivity and specificity were significantly different between all groups except SRU versus TI-RADS. The Risk Threshold Algorithm, based on a malignancy risk model, demonstrates increased overall diagnostic accuracy as compared with ACR TI-RADS, SRU, and ATA management guidelines. Through eliminating unnecessary biopsy, patient anxiety, and morbidity can be reduced.

Case Report: Hepatic Fascioliasis in a Young Afghani Woman with Severe Wheezing, High-Grade Peripheral Eosinophilia, and Liver Lesions: A Brief Literature Review.

A 23-year-old recent emigrant from Afghanistan presented in August 2017 with severe wheezing and dyspnea that required hospital admission. Her illness was associated with marked peripheral blood eosinophilia (9,900-15,600/µL; 45.2-68%), as well as mild nausea, epigastric pain, and decreased appetite. She had lived until 3 months earlier in close proximity to cattle in her home in Kabul and did not recall eating watercress or other leafy plants associated with Fasciola hepatica transmission. Computerized tomography scanning showed bilateral ground-glass lung consolidations and multiple distinctive hypo-attenuating linear, tubuliform, and nodular liver lesions, including a large subcapsular hematoma. Numerous tests for rheumatological and malignant disorders were negative. Fasciola hepatica infestation was suspected on epidemiological, clinical, and radiographic grounds, and was confirmed by immunoblotting at the Centers for Disease Control (CDC). Multiple stool ova and parasite examinations were negative and endoscopic retrograde cholangiopancreatography did not identify trematodes. Her acute respiratory illness resolved with asthma-targeted therapies and her eosinophilia resolved with triclabendazole, which was obtained from CDC via an FDA Investigational New Drug application. Fascioliasis is uncommon in the United States, but the prolonged warfare and civil strife in Afghanistan and adjacent areas may lead to increased incidence outside the endemic region. Her case also demonstrates how hepatic imaging features of fascioliasis can be pathognomonic in clinical scenarios with eosinophilia and appropriate epidemiology and clinical features. We also highlight her relatively unusual presentation with symptoms of Loeffler-like syndrome alone.

Assessment of PI-RADS v2 categories ≥ 3 for diagnosis of clinically significant prostate cancer.

PURPOSE: To assess the diagnostic accuracy of PI-RADS v2 categories ≥ 3 to detect clinically significant prostate cancer (csPCa) against histopathology of Transperineal Mapping Biopsy (TPMB). MATERIALS AND METHODS: IRB-approved retrospective cohort study included 47 men who had 3.0 T multi-parametric MRI (mpMRI) and TPMB of prostate. Two radiologists independently evaluated T2, DWI, ADC map, and DCE images using PI-RADS v2 categories. A third radiologist served as tie-breaker. PI-RADS v2 score (PS) ≥ 3 lesions were correlated with 3D model of TPMB (3DTPMB) results based on prostate sectors. Two groups of csPCa status were separately analyzed for accuracy measures at lesion and person levels: Group 1 with GS (Gleason Score) ≥ 7 and group 2 with tumor volume ≥ 0.5 cc. Inter-rater reliability for PS and MR lexicon was calculated. RESULTS: Forty-seven patients with 3DTPMB had at least one lesion with PS ≥ 3 on mpMRI. PS of 5 had high PPV and high specificity of 100% at the lesion and person levels. Sensitivity of a PS ≥ 3 was 68.27% for group 1 and was 48.39% for group 2. Specificity was 93.56% for group 1 and was 95.53% for group 2. At the person level, sensitivity of PS ≥ 3 was 81.25% for group 1 and was 82.35% for group 2. Specificity was 32.26% for group 1 and was 53.85% for group 2. CONCLUSION: PI-RADS v2 category of 5 had high PPV and specificity; however, combined PS ≥ 3 had mixed performance in detection of csPCa.