US Biopsy Research Articles

Contrast-enhanced US versus US-guided biopsy for abdominal and pelvic neoplasm in paediatric patients: a propensity score matching study.

To compare the diagnostic performance of CEUS-guided biopsy (CEUS-GB) and ultrasound-guided biopsy (US-GB) in evaluating abdominal and pelvic (abdominopelvic) neoplasms in paediatric patients. Patients aged < 18 years with abdominopelvic tumours who underwent either CEUS-GB or US-GB between April 2005 and May 2022 were retrospectively evaluated. Tumours diagnosed as malignancies by pathology were considered true-positive findings. Benign lesions were identified by pathology or clinical follow-up of at least 6 months. The diagnostic performance of the two groups was compared using propensity score matching (PSM). Complications were also analysed. The present study included 764 paediatric patients (437 boys; median age, 24 months; interquartile range, 10-60 months); 151 were in the CEUS-GB group, and 613 were in the US-GB group. The sample adequacy rate was 100% (151 of 151) for the CEUS-GB group, which was greater than the 97.4% (597 of 613) for the US-GB group (p < 0.001). The overall diagnostic accuracy of the CEUS-GB group and US-GB group was 98.7% (149 of 151) versus 97.3% (581 of 597) in the total cohort (p = 0.551) and 98.7% (149 of 151) versus 92.7% (140 of 151) in the PSM cohort (p = 0.020). Two patients (0.3%) in the US-GB group experienced complications (Common Terminology Criteria for Adverse Events (CTCAE), grade 1-2) correlated with the biopsy. No adverse reactions occurred in the CEUS-GB group. CEUS-GB of abdominopelvic tumours in paediatric patients is an effective and safe procedure with greater diagnostic accuracy than US-GB, especially for tumours with necrotic areas. Contrast-enhanced US-guided biopsy of solid abdominal and pelvic tumours in paediatric patients is an effective and safe procedure with greater diagnostic accuracy than US-guided biopsy, especially for tumours with necrotic areas. Contrast-enhanced ultrasound (CEUS) may be superior to conventional ultrasound at guiding biopsy of abdominopelvic masses in paediatric patients. CEUS-guided core needle biopsy of abdominopelvic masses in children was safe and resulted in a diagnostic yield of 98.7%. CEUS guidance should be considered in this population when colour Doppler US is unable to determine a biopsy site.

Novel clinical risk calculator for improving cancer predictability of mpMRI fusion biopsy in prostates.

Prostate Imaging-Reporting and Data System (PI-RADS) assists in evaluating lesions on multiparametric magnetic resonance imaging (mpMRI), but there are still ongoing efforts in improving the predictive value for the presence of clinically significant PCa (csPCa) with a Gleason grade group ≥ 2 on Fusion-Biopsy. This pilot study intends to propose an easily implementable method for augmenting predictability of csPCa for PI-RADS. A cohort of 151 consecutive patients underwent mpMRI Fusion and random US Biopsy as a result of having at least one PI-RADS lesion grade 3-5 between January 1, 2019 and December 31, 2022. A single radiologist reads all films in this study applying PI-RADS V2. Of the 151 consecutive patients, 49 had a highest lesion of PI-RADS 3, 82 had a highest lesion of PI-RADS 4, and 20 had a highest lesion of PI-RADS 5. For each respective group, 12, 42, and 18 patients had proven csPCa. Two predictive models for csPCa were created by employing a logistical regression with parameters readily available to providers. The models had an AUC of 0.8133 and 0.8206, indicating promising effective models. PI-RADS classification has relevant predictability problems for grades 3 and 4. By applying the presented risk calculators, patients with PI-RADS 3 and 4 are better stratified, and thus, a significant number of patients can be spared biopsies with potential complications, such as infection and bleeding. The presented predictive models may be a valuable diagnostic tool, adding additional information in the clinical decision-making process for biopsies.

Comparison of Radiologists and Deep Learning for US Grading of Hepatic Steatosis.

Background Screening for nonalcoholic fatty liver disease (NAFLD) is suboptimal due to the subjective interpretation of US images. Purpose To evaluate the agreement and diagnostic performance of radiologists and a deep learning model in grading hepatic steatosis in NAFLD at US, with biopsy as the reference standard. Materials and Methods This retrospective study included patients with NAFLD and control patients without hepatic steatosis who underwent abdominal US and contemporaneous liver biopsy from September 2010 to October 2019. Six readers visually graded steatosis on US images twice, 2 weeks apart. Reader agreement was assessed with use of κ statistics. Three deep learning techniques applied to B-mode US images were used to classify dichotomized steatosis grades. Classification performance of human radiologists and the deep learning model for dichotomized steatosis grades (S0, S1, S2, and S3) was assessed with area under the receiver operating characteristic curve (AUC) on a separate test set. Results The study included 199 patients (mean age, 53 years ± 13 [SD]; 101 men). On the test set (n = 52), radiologists had fair interreader agreement (0.34 [95% CI: 0.31, 0.37]) for classifying steatosis grades S0 versus S1 or higher, while AUCs were between 0.49 and 0.84 for radiologists and 0.85 (95% CI: 0.83, 0.87) for the deep learning model. For S0 or S1 versus S2 or S3, radiologists had fair interreader agreement (0.30 [95% CI: 0.27, 0.33]), while AUCs were between 0.57 and 0.76 for radiologists and 0.73 (95% CI: 0.71, 0.75) for the deep learning model. For S2 or lower versus S3, radiologists had fair interreader agreement (0.37 [95% CI: 0.33, 0.40]), while AUCs were between 0.52 and 0.81 for radiologists and 0.67 (95% CI: 0.64, 0.69) for the deep learning model. Conclusion Deep learning approaches applied to B-mode US images provided comparable performance with human readers for detection and grading of hepatic steatosis. Published under a CC BY 4.0 license. Supplemental material is available for this article. See also the editorial by Tuthill in this issue.

Predicting successful ultrasound-guided biopsy of liver lesions.

To determine the factors that affect successful ultrasound-guided biopsy of liver lesions and build a model predicting feasibility of US-guided liver biopsy. This is IRB-approved HIPAA-compliant retrospective review of consecutive ultrasound-guided targeted liver biopsies performed or attempted between 1/2018 and 9/2020 at a single tertiary academic institution with a total of 501 patients included. Mann-Whitney and chi-square tests were used to compare continuous and categorical variables, respectively. Logistic regression model was built to predict feasibility of successful ultrasound-guided biopsy. Liver lesion biopsy was successfully performed with US guidance in 429/501 (86%) patients. Lesions not amenable for US biopsy were smaller (median size 1.6 cm vs 3.3 cm, p < 0.0001) and deeper within the liver (median depth 9.0 cm vs 5.8 cm, p < 0.0001). The technical success rate was lowest for lesions in segment II (40/53, 75%), while lesions in segment IVb (87/91, 96%) had highest success rate (p < 0.003). US targeting in patients with 1 or 2 lesions was less feasible than in patients with 3 or more lesions, 126/180 (70%) vs. 303/321 (94%), (p < 0.0001). Model including lesion size, depth, location, and number of lesions predicts feasibility of US-guided biopsy with Area under the ROC curve (AUC) = 0.92. Linear logistic regression model that includes lesion size, depth and location, and number of lesions is highly successful in predicting feasibility of ultrasound-guided biopsy for liver lesions. Smaller lesions, deeper lesions, and lesions in segment II and VIII in patients with less than 3 lesions were less feasible for ultrasound-guided biopsy of liver lesions.

Internal mammary node involvement in patients with axilla-negative early breast cancer: a narrative review.

Early breast cancer staging involves radiological and pathological evaluation of the tumour and regional lymph nodes. The internal mammary nodes (IMN) are an important site of possible metastasis and influence disease stage and prognosis. However, the recommendation for routine IMN assessment remains unclear. Internal mammary sentinel lymph node biopsy (SLNB) is associated with increased morbidity and an unknown survival benefit. Furthermore, the IMN are traditionally thought to be involved only synchronous with, or following, axillary node (AXN) metastasis. The aim of this review is to determine the prevalence of IMN metastasis in patients with axilla-negative early breast cancer. A narrative review of studies assessing IMN metastasis was performed. The literature search was completed using the database Medline (Ovid). Twenty-two retrospective studies were identified. The studies included data from SLNB, US, MRI, PET/CT and opportunistic biopsy during free-flap reconstruction (FFR). The prevalence of isolated IMN metastasis ranged from 1.2% to 17.9%.

Comparing Radiologist Performance in Diagnosing Clinically Significant Prostate Cancer with Multiparametric versus Hybrid Multidimensional MRI.

Background Variability of acquisition and interpretation of prostate multiparametric MRI (mpMRI) persists despite implementation of the Prostate Imaging Reporting and Data System (PI-RADS) version 2.1 due to the range of reader experience and subjectivity of lesion characterization. A quantitative method, hybrid multidimensional MRI (HM-MRI), may introduce objectivity. Purpose To compare performance, interobserver agreement, and interpretation time of radiologists using mpMRI versus HM-MRI to diagnose clinically significant prostate cancer. Materials and Methods In this retrospective analysis, men with prostatectomy or MRI-fused transrectal US biopsy-confirmed prostate cancer underwent mpMRI (triplanar T2-weighted, diffusion-weighted, and dynamic contrast-enhanced imaging) and HM-MRI (with multiple echo times and b value combinations) from August 2012 to February 2020. Four readers with 1-20 years of experience interpreted mpMRI and HM-MRI examinations independently, with a 4-week washout period between interpretations. PI-RADS score, lesion location, and interpretation time were recorded. mpMRI and HM-MRI interpretation time, interobserver agreement (Cronbach alpha), and performance of area under the receiver operating characteristic curve (AUC) analysis were compared for each radiologist with use of bootstrap analysis. Results Sixty-one men (mean age, 61 years ± 8 [SD]) were evaluated. Per-patient AUC was higher for HM-MRI for reader 4 compared with mpMRI (AUCs for readers 1-4: 0.61, 0.71, 0.59, and 0.64 vs 0.66, 0.60, 0.50, and 0.46; P = .57, .20, .32, and .04, respectively). Per-patient specificity was higher for HM-MRI for readers 2-4 compared with mpMRI (specificity for readers 1-4: 48%, 78%, 48%, and 46% vs 37%, 26%, 0%, and 7%; P = .34, P < .001, P < .001, and P < .001, respectively). Diagnostic performance improved for the reader least experienced with HM-MRI, reader 4 (AUC, 0.64 vs 0.46; P = .04). HM-MRI interobserver agreement (Cronbach alpha = 0.88 [95% CI: 0.82, 0.92]) was higher than that of mpMRI (Cronbach alpha = 0.26 [95% CI: 0.10, 0.52]; α > .60 indicates reliability; P = .03). HM-MRI mean interpretation time (73 seconds ± 43 [SD]) was shorter than that of mpMRI (254 seconds ± 133; P = .03). Conclusion Radiologists had similar or improved diagnostic performance, higher interobserver agreement, and lower interpretation time for clinically significant prostate cancer with hybrid multidimensional MRI than multiparametric MRI. © RSNA, 2022 Online supplemental material is available for this article. See also the editorial by Turkbey in this issue.

Diagnosis of significant liver fibrosis in patients with chronic hepatitis B using a deep learning-based data integration network.

Chronic hepatitis B virus (CHB) infection remains a major global health burden and the non-invasive and accurate diagnosis of significant liver fibrosis (≥ F2) in CHB patients is clinically very important. This study aimed to assess the potential of the joint use of ultrasound images of liver parenchyma, liver stiffness values, and patients' clinical parameters in a deep learning model to improve the diagnosis of ≥ F2 in CHB patients. Of 527 CHB patients who underwent US examination, liver elastography and biopsy, 284 eligible patients were included. We developed a deep learning-based data integration network (DI-Net) to fuse the information of ultrasound images of liver parenchyma, liver stiffness values and patients' clinical parameters for diagnosing ≥ F2 in CHB patients. The performance of DI-Net was cross-validated in a main cohort (n = 155) of the included patients and externally validated in an independent cohort (n = 129), with comparisons against single-source data-based models and other non-invasive methods in terms of the area under the receiver-operating-characteristic curve (AUC). DI-Net achieved an AUC of 0.943 (95% confidence interval [CI] 0.893-0.973) in the cross-validation, and an AUC of 0.901 (95% CI 0.834-0.945) in the external validation, which were significantly greater than those of the comparative methods (AUC ranges: 0.774-0.877 and 0.741-0.848 for cross- and external validations, respectively, ps < 0.01). The joint use of ultrasound images of liver parenchyma, liver stiffness values, and patients' clinical parameters in a deep learning model could significantly improve the diagnosis of ≥ F2 in CHB patients.

Abstract P1-01-14: Axillary assessment by Systemic Axillary Sonography (SAS) for axillary disease treated with neoadjuvant chemotherapy

Abstract Objective. For patients with breast cancer related lymph node metastases, neoadjuvant chemotherapy (NAC) can de-escalate axillary surgery. A radiologic marker (RM) is commonly placed at the time of the initial biopsy to ensure removal of that node at final surgery, but the utility of this marker is largely debated. Systematic Axillary Sonography (SAS) consists of a thorough sonographic axillary staging before and after NAC with possible post NAC node biopsy and has been previously suggested as an alternative. The primary aim of this study was to assess the effectiveness of SAS in axillary evaluation after NAC. The secondary aim was to compare the effectiveness of SAS to RM. Methods. A retrospective analysis of prospectively collected data from 95 patients from 2010 to 2020 at University of Miami Hospital and Jackson Memorial Hospital. Study inclusion criteria were positive axillary lymph node (LN) biopsy, NAC, performance of SAS and axillary surgery. Results. 89 patients were analyzable. The median age was 49±12. All patients had clinical axillary exam and axillary US with positive LN biopsy. 62 patients had additional breast MRI before treatment. All patients had clinical axillary exam and axillary US after chemotherapy. 58 patients had post-treatment MRI and 49 repeated axillary LN biopsy. Pre-treatment clinical exam of the axilla had a sensitivity of 73%. When MRI was added the sensitivity rose to 95%. Since axillary US and positive axillary node biopsy were a prerequisite, the sensitivity of pre-NAC US cannot be assessed. After chemotherapy, all patient underwent axillary examination and US assessment. Repeated axillary clinical exam had low sensitivity of 31% and high specificity of 85%. Repeat MRI exam showed low sensitivity and specificity of 53% and 49% respectively. Post-NAC US without subsequent LN biopsy had a sensitivity of 55% with specificity of 67%. The addition of repeat axillary LN biopsy increased the sensitivity of SAS to 100%. 59 patients in our group had RM placed during pre-NAC axillary LN biopsy. 24 underwent axillary dissection without sentinel lymph node biopsy (SLNB) and 35 patients had a SLNB. The RM was retrieved in 32/35 patients. The “clipped” node was also sentinel node in 66% (12/35). The final pathology revealed benign results in all “clipped” non-sentinel nodes. 18% (6/33) of patients with “clipped” node were diagnosed with axillary metastases in “non-clipped” lymph nodes. Conclusion. SAS is a cheap, quick and reliable method facilitating pre and post-treatment assessment and restaging of the axilla after NAC. Post-NAC biopsy, when indicated, better defines eligibility for axillary surgery decreasing morbidity and cost. In this study, placement of a RM was of no significant benefit. Patient characteristicsRaceTumor gradeWhite, non-hispanic19Gr 13White-hispanic46Gr 240Black, non-hispanic18Gr 346Asian3Receptor statusUnknown3HR+/HER2-42Age49+/-12HR+/HER2+19BMI29+/-5.7HR-/HER2+7Menopausal statusHR-/HER2-21Premenopausal49Tumor sizePostmenopausal40T19T238T328T414LN statusN158N221N310 Citation Format: Siarhei Melnikau, Christina Layton, Tolga Ozmen, Megan Allen, Eli Avisar. Axillary assessment by Systemic Axillary Sonography (SAS) for axillary disease treated with neoadjuvant chemotherapy [abstract]. In: Proceedings of the 2021 San Antonio Breast Cancer Symposium; 2021 Dec 7-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2022;82(4 Suppl):Abstract nr P1-01-14.

To Look or Not to Look? Axillary Imaging: Less May Be More.

Axillary lymph node status in patients with breast cancer is an important prognostic indicator and often guides vital treatment decisions. Although in many cases imaging plays a crucial role in the assessment of the axilla, it is essential that targeted axillary US and/or image-guided biopsy of an axillary lymph node be performed by the radiologist only when clinically appropriate. This decision-making process requires multidisciplinary communication and collaboration among radiologists, surgeons, medical oncologists, and radiation oncologists. Our goal is to review axillary imaging for patients with breast cancer in two distinct clinical settings, the patient with newly diagnosed breast cancer who meets American College of Surgeons Oncology Group Z0011 criteria and patients undergoing neoadjuvant chemotherapy, with a specific focus on potential reasons to not perform axillary US and/or image-guided biopsy in these settings.

Diagnostic performance of 68Ga-PSMA-11 PET/MRI-guided biopsy in patients with suspected prostate cancer: a prospective single-center study

PurposeUltrasound-guided biopsy (US biopsy) with 10–12 cores has a suboptimal sensitivity for clinically significant prostate cancer (sigPCa). If US biopsy is negative, magnetic resonance imaging (MRI)–guided biopsy is recommended, despite a low specificity for lesions with score 3–5 on Prostate Imaging Reporting and Data System (PIRADS). Screening and biopsy guidance using an imaging modality with high accuracy could reduce the number of unnecessary biopsies, reducing side effects. The aim of this study was to assess the performance of positron emission tomography/MRI with 68Ga-labeled prostate-specific membrane antigen (PSMA-PET/MRI) to detect and localize primary sigPCa (ISUP grade group 3 and/or cancer core length ≥ 6 mm) and guide biopsy.MethodsProspective, open-label, single-center, non-randomized, diagnostic accuracy study including patients with suspected PCa by elevation of prostate-specific antigen (PSA) level and a suspicious lesion (PIRADS ≥3) on multiparametric MRI (mpMRI). Forty-two patients underwent PSMA-PET/MRI followed by both PSMA-PET/MRI-guided and section-based saturation template biopsy between May 2017 and February 2019. Primary outcome was the accuracy of PSMA-PET/MRI for biopsy guidance using section-based saturation template biopsy as the reference standard.ResultsSigPCa was found in 62% of the patients. Patient-based sensitivity, specificity, negative and positive predictive value, and accuracy for sigPCa were 96%, 81%, 93%, 89%, and 90%, respectively. One patient had PSMA-negative sigPCa. Eight of nine false-positive lesions corresponded to cancer on prostatectomy and one in six false-negative lesions was negative on prostatectomy.ConclusionPSMA-PET/MRI has a high accuracy for detecting sigPCa and is a promising tool to select patients with suspicion of PCa for biopsy.Trial registrationThis trial was retrospectively registered under the name “Positron Emission Tomography/Magnetic Resonance Imaging (PET/MRI) Guided Biopsy in Men with Elevated PSA” (NCT03187990) on 06/15/2017 (https://clinicaltrials.gov/ct2/show/NCT03187990).

Axillary Nodal Evaluation in Breast Cancer: State of the Art.

Axillary lymph node (LN) metastasis is the most important predictor of overall recurrence and survival in patients with breast cancer, and accurate assessment of axillary LN involvement is an essential component in staging breast cancer. Axillary management in patients with breast cancer has become much less invasive and individualized with the introduction of sentinel LN biopsy (SLNB). Emerging evidence indicates that axillary LN dissection may be avoided in selected patients with node-positive as well as node-negative cancer. Thus, assessment of nodal disease burden to guide multidisciplinary treatment decision making is now considered to be a critical role of axillary imaging and can be achieved with axillary US, MRI, and US-guided biopsy. For the node-positive patients treated with neoadjuvant chemotherapy, restaging of the axilla with US and MRI and targeted axillary dissection in addition to SLNB is highly recommended to minimize the false-negative rate of SLNB. Efforts continue to develop prediction models that incorporate imaging features to predict nodal disease burden and to select proper candidates for SLNB. As methods of axillary nodal evaluation evolve, breast radiologists and surgeons must work closely to maximize the potential role of imaging and to provide the most optimized treatment for patients.

Isolation of Mycobacterium lepromatosis and Development of Molecular Diagnostic Assays to Distinguish Mycobacterium leprae and M. lepromatosis.

Mycobacterium leprae was thought to be the exclusive causative agent of leprosy until Mycobacterium lepromatosis was identified in a rare form of leprosy known as diffuse lepromatous leprosy (DLL). We isolated M. lepromatosis from a patient with DLL and propagated it in athymic nude mouse footpads. Genomic analysis of this strain (NHDP-385) identified a unique repetitive element, RLPM, on which a specific real-time quantitative polymerase chain reaction assay was developed. The RLPM assay, and a previously developed RLEP quantitative polymerase chain reaction assay for M. leprae, were validated as clinical diagnostic assays according to Clinical Laboratory Improvement Amendments guidelines. We tested DNA from archived histological sections, patient specimens from the United States, Philippines, and Mexico, and US wild armadillos. The limit of detection for the RLEP and RLPM assays is 30 M. leprae per specimen (0.76 bacilli per reaction; coefficient of variation, 0.65%-2.44%) and 122 M. lepromatosis per specimen (3.05 bacilli per reaction; 0.84%-2.9%), respectively. In histological sections (n = 10), 1 lepromatous leprosy (LL), 1 DLL, and 3 Lucio reactions contained M. lepromatosis; 2 LL and 2 Lucio reactions contained M. leprae; and 1 LL reaction contained both species. M. lepromatosis was detected in 3 of 218 US biopsy specimens (1.38%). All Philippines specimens (n = 180) were M. lepromatosis negative and M. leprae positive. Conversely, 15 of 47 Mexican specimens (31.91%) were positive for M. lepromatosis, 19 of 47 (40.43%) were positive for M. leprae, and 2 of 47 (4.26%) contained both organisms. All armadillos were M. lepromatosis negative. The RLPM and RLEP assays will aid healthcare providers in the clinical diagnosis and surveillance of leprosy.

Diagnostic Interventions of Small < 2.5mm Focal Liver Lesions: US and CT-guided Biopsy

Diagnostic Interventions of Small < 2.5mm Focal Liver Lesions: US and CT-guided Biopsy

New Era for Usage of Serum Liver Enzymes as A Promising Horizon for the Prediction of Non-Alcoholic Fatty Liver Disease.

BACKGROUND:Liver histology remains the gold standard for assessing non-alcoholic fatty liver disease (NAFLD). Noninvasive serological markers and radiological methods have been developed to evaluate steatosis to avoid biopsy.AIM:To put cutoff value for liver enzymes that could predict non-alcoholic steatohepatitis (NASH).PATIENTS AND METHODS:This study was conducted on 54 patients (with NAFLD diagnosed by the US). Patients were subjected to history, physical, anthropometric measurements, investigations including liver enzymes, abdominal US, and liver biopsy. According to biopsy results, patients were subdivided according to NASH development. Also, biopsy results were correlated to the levels of liver enzymes.RESULTS:Forty-seven patients who were suspected to have NAFLD by sonar were confirmed by biopsy. There was a significant correlation between steatosis degree in biopsy and sonar. Correlation study between steatosis in biopsy and ALT level showed highly significant positive correlation. Correlation study between steatosis in biopsy on one side & AST and GGT on the other side showed significant positive correlation. Cutoff value for detection of NASH using ALT & AST & and GGT were 50.5, 56, 60.5 respectively with sensitivity = 95.5, 90.5, 86.4 % and specificity = 93.8, 100, 87.5%.CONCLUSION:Cut off values of liver enzymes can be combined with abdominal sonar to predict NASH.

Ultrasound-guided Lung Biopsy in the Hands of Respiratory Physicians: Diagnostic Yield and Complications in 215 Consecutive Patients in 3 Centers.

The aim of the study was to determine the diagnostic yield and prevalence of complications of ultrasound-guided transthoracic needle aspiration biopsies (US-TTNAB) performed by respiratory physicians after implementation of the procedure in an everyday clinical setting at 3 different centers. Patients were included if they during the period from January 2012 to August 2014 had a registered US-TTNAB procedure code or if a US biopsy registration form had been filled out at either of the participating centers. Histology or cytology results were used as a reference test for diagnoses that could be made based on these results. Reference test for the remaining diagnoses was clinical follow-up. The diagnostic yield of US-TTNAB was defined as the proportion of patients in which the result of the US-TTNAB was consistent with the reference test. A total of 215 patients in which a primary US-TTNAB had been performed were identified. The most common biopsy sites were lungs and pleurae with a total of 164 (76.3%) patients and 31 patients (14.4%), respectively. US-TTNAB diagnostic yield was 76.9% (95% CI, 70.3%-83.4%) for malignant diagnoses and 47.6% (95% CI, 31.9%-63.4%) for nonmalignant diagnoses. The most common complications of US-TTNAB were pneumothorax (2.5%; 95% CI, 0.03%-4.6%) and pain at the biopsy site (2%; 95% CI, 0.04%-3.9%). No fatalities related to US-TTNAB were observed. US-TTNAB performed by respiratory physicians is a safe procedure with a low risk of complications and the diagnostic yield to establish a malignant diagnosis is acceptable.

Can adding contrast-enhanced digital mammography (CEDM) as an adjunct to diagnostic mammography/US help decrease biopsy rates in women with suspicious (BIRADS 4) breast lesions?

6 Background: Traditional screening mammography (MG) enables early detection of breast cancer and therefore results in decreased mortality. Mammography, however, is an imperfect tool and limited by an overall sensitivity of 75-85%. Specificity is limited as well resulting in many false-positive examinations and unnecessary follow-up examinations. The recent development of contrast-enhanced digital mammography (CEDM) has made the usage of IV contrast enhancement with mammography a possibility. CEDM is an angiographic technique that uses digital subtraction, which removes the normal mammary gland on images in order to detect breast tumors and visualize their vascularity. The literature is promising with regard to CEDM as studies have found that CEDM achieves increased sensitivity without reductions in specificity in comparison to MG, US and/or MRI. Methods: In this multi-reader study we compared the diagnostic accuracy of CEDM as an adjunct to MG/US in patients with suspicious findings (BI-RADS 4). The study population included 31 patients who were imaged with CEDM prior to their scheduled US or stereotactic-guided biopsy. We compared the relative performance of MG/US alone versus MG/US/CEDM in determining the probability of malignancy. Histology served as the gold standard. Results: See table below. Conclusions: The addition of CEDM to the workup of suspected lesions on MG and/or US preliminarily decreases the number of false-positive MG thereby with potential to reduce cost and unnecessary patient harm. [Table: see text]

Advanced Breast Imaging Availability by Screening Facility Characteristics

To determine the relationship between screening mammography facility characteristics and on-site availability of advanced breast imaging services required for supplemental screening and the diagnostic evaluation of abnormal screening findings. We analyzed data from all active imaging facilities across six regional registries of the National Cancer Institute-funded Breast Cancer Surveillance Consortium offering screening mammography in calendar years 2011-2012 (n = 105). We used generalized estimating equations regression models to identify associations between facility characteristics (eg, academic affiliation, practice type) and availability of on-site advanced breast imaging (eg, ultrasound [US], magnetic resonance imaging [MRI]) and image-guided biopsy services. Breast MRI was not available at any nonradiology or breast imaging-only facilities. A combination of breast US, breast MRI, and imaging-guided breast biopsy services was available at 76.0% of multispecialty breast centers compared to 22.2% of full diagnostic radiology practices (P = .0047) and 75.0% of facilities with academic affiliations compared to 29.0% of those without academic affiliations (P = .04). Both supplemental screening breast US and screening breast MRI were available at 28.0% of multispecialty breast centers compared to 4.7% of full diagnostic radiology practices (P < .01) and 25.0% of academic facilities compared to 8.5% of nonacademic facilities (P = .02). Screening facility characteristics are strongly associated with the availability of on-site advanced breast imaging and image-guided biopsy service. Therefore, the type of imaging facility a woman attends for screening may have important implications on her timely access to supplemental screening and diagnostic breast imaging services.

PB.31. Occult breast carcinoma: an experience at a single unit

The breast carcinoma presents rarely as metastases to the axillary nodes without an obvious breast lesion seen on conventional imaging such as mammography and US. In this study we looked at the usefulness of DCE-MRI of the breast in identifying these tumours at a single institute. In addition we evaluated the use of second-look US and MRI-guided biopsy.

Imaging and pathology findings after an initial negative MRI-US fusion-guided and 12-core extended sextant prostate biopsy session

A magnetic resonance imaging-ultrasonography (MRI-US) fusion-guided prostate biopsy increases detection rates compared to an extended sextant biopsy. The imaging characteristics and pathology outcomes of subsequent biopsies in patients with initially negative MRI-US fusion biopsies are described in this study. We reviewed 855 biopsy sessions of 751 patients (June 2007 to March 2013). The fusion biopsy consisted of two cores per lesion identified on multiparametric MRI (mpMRI) and a 12-core extended sextant transrectal US (TRUS) biopsy. Inclusion criteria were at least two fusion biopsy sessions, with a negative first biopsy and mpMRI before each. The detection rate on the initial fusion biopsy was 55.3%; 336 patients had negative findings. Forty-one patients had follow-up fusion biopsies, but only 34 of these were preceded by a repeat mpMRI. The median interval between biopsies was 15 months. Fourteen patients (41%) were positive for cancer on the repeat MRI-US fusion biopsy. Age, prostate-specific antigen (PSA), prostate volume, PSA density, digital rectal exam findings, lesion diameter, and changes on imaging were comparable between patients with negative and positive rebiopsies. Of the patients with positive rebiopsies, 79% had a positive TRUS biopsy before referral (P = 0.004). Ten patients had Gleason 3+3 disease, three had 3+4 disease, and one had 4+4 disease. In patients with a negative MRI-US fusion prostate biopsy and indications for repeat biopsy, the detection rate of the follow-up sessions was lower than the initial detection rate. Of the prostate cancers subsequently found, 93% were low grade (≤ 3+4). In this low risk group of patients, increasing the follow-up time interval should be considered in the appropriate clinical setting.

Novel Kras-directed therapy in combination with chemotherapy for locally advanced pancreatic adenocarcinoma.

270 Background: K-Ras mutation G12D is most prevalent in pancreatic adenocarcinoma (PDAC). siRNA against the K-RasG12D(siG12D) mutant had showed significant preclinical anti-tumor effects. siG12D LODER - is a miniature biodegradable polymeric matrix that encompasses anti K-RasG12D siRNA drug, designed to release the drug regionally along 4 months. The siG12D LODER is placed with Endoscopic US biopsy. Methods: Open label phase I study of patients with locally advanced non-operable PDAC in the first-line setting. Patients were assigned to receive siG12D LODERs in a dose escalation, dose cohorts were: 0.025mg, 0.75mg and 3.0mg. Gemcitabine 1000 mg/m2IV was given on a weekly basis, following the siG12D LODER insertion, until disease progression. The RP2D (recommended phase II dose) was further examined in highest dose cohort in combination with modified Folfirinox (Oxaliplatin 85mg/m2, Irinotecan 150mg/m2 followed by a Fluorouracil continuous IV infusion 2,400mg/m2 46 hours every 2 weeks). Follow up period was 8 weeks and survival follow up until death. Primary study objectives were to determine the dose-limiting toxicities (DLT) and maximum tolerated doses (MTD). Results: 15 patients with locally advanced PDAC have been enrolled. Two patients were omitted from study but followed for safety due to metastatic disease detected on day 1 post siG12D LODER implant imaging. Median age = 70 (range 52-85); male:female =8:7. Among 13 treated patients, the most frequent adverse events observed in the study were typically grade 1- 2 in severity; 4 patients experienced serious adverse events (SAE). No DLTs were observed. CT performed 8-12 weeks following the procedure showed tumor regression in 66% (8 of the first 12 patients, 7/8 from 2nd and 3rd cohorts).Reduction in tumor marker CA 19-9 was observed in 64% (7/11) of patients. Median overall survival was 16.26 months, 14.01 months and 15.11 months in the 0.025 mg, 0.75 mg and the 3 mg treatment groups respectively. Conclusions: The combination of siG12D LODER and chemotherapy is well tolerated. The combination has demonstrated promising efficacy in locally advanced pancreatic cancer with durable responses. NCT01188785. Clinical trial information: NCT01188785.