ACR Appropriateness Criteria® Acute Onset Flank Pain-Suspicion of Stone Disease (Urolithiasis).

Noncontrast CT (NCCT) is the imaging study of choice for initial evaluation of patients with acute onset of flank pain and suspicion of stone disease without known prior stone disease. NCCT can reliably characterize the location and size of an offending ureteral calculus, identify complications, and diagnose alternative etiologies of abdominal pain. Although less sensitive in the detection of stones, ultrasound may have a role in evaluating for signs of obstruction. Radiography potentially has a role, although has been shown to be less sensitive than NCCT. For patients with known disease and recurrent symptoms of urolithiasis, NCCT remains the test of choice for evaluation. In pregnancy, given radiation concerns, ultrasound is recommended as the initial modality of choice with potential role for noncontrast MRI. In scenarios where stone disease suspected and initial NCCT is inconclusive, contrast-enhanced imaging, either with MRI or CT/CT urogram may be appropriate. 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.

Evaluation of Recurrent Disease after Radiation Therapy for Patients Considering Local Salvage Therapy: Past vs. Contemporary Management.

Recurrent prostate cancer after primary treatment with radiation therapy is a common problem. Patients with localized recurrence may benefit from salvage therapy, but careful patient selection is crucial because not all patients will benefit from local salvage therapy, and salvage therapy has increased morbidity compared to primary treatments for prostate cancer. This review aims to provide an overview of the evaluation of patients with recurrent disease after radiation therapy and how it is continuing to evolve with increasing data on outcomes, as well as improving technologies and techniques. Our enhanced understanding of treatment outcomes and risk stratification has influenced the identification of patients who may benefit from local salvage treatment. Advances in imaging and biopsy techniques have enhanced the accuracy of locating the recurrence, which affects treatment decisions. Additionally, the growing interest in image-targeted ablative therapies that have less morbidity and complications than whole-gland therapies for suitable patients influences the evaluation process for those considering focal salvage therapy. Although significant changes have been made in the diagnostic evaluation of patients with recurrent disease after radiation therapy, it remains unclear whether these changes will ultimately improve patient outcomes.

Surveillance one year post focal cryotherapy for clinically significant prostate cancer using mpMRI and PIRADS v2.1: An initial experience from a prospective phase II mandatory biopsy study.

Objectives: Multiparametric magnetic resonance imaging (mpMRI) surveillance post focal cryotherapy (FT) of prostate cancer is challenging as post treatment artefacts alter mpMRI findings. In this initial experience, we assessed diagnostic performance of mpMRI in detecting clinically significant prostate cancer (csPCa) after FT. Materials and methods: This single-centre phase II prospective clinical trial recruited 28 men with localized csPCa for FT between October 2019 and April 2021. 12-months post FT mpMRI were performed prior to biopsy and sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of all mpMRI positive subjects were analysed. Chi square goodness of fit test correlated biopsy positive PIRADS3 (P3) and PIRADS4/5 lesions with histology grade group. One way ANOVA test assessed performance of ADC values in differentiating csPCa, non csPCa and benign lesions. Results: Sensitivity, specificity, PPV and NPV of mpMRI were 100%, 14.28%, 53.84% and 100% for subjects with histologically proven cancer. Correlation of PIRADS v2.1 scores with histologically proven prostate cancer was statistically significant (p < 0.5). Correlation of P3 lesions with non-csPCa was statistically significant (p < 0.02535). Higher ADC value was associated with benign histology (adjusted odds ratio OR 0.97, 95% confidence interval: 0.94, 0.99) (p = 0.008). Among the malignant lesions, higher ADC value was associated with non-csPCa (adjusted OR: 0.97; 95% CI: 0.95, 0.99) (p = 0.032). Conclusion: mpMRI is highly sensitive in detecting residual cancer. ADC values and PIRADS scores may be of value in differentiating csPCa from non-csPCa with a potential for risk stratification of men requiring re-biopsy versus non-invasive surveillance of remnant prostate.

Optimization of non-endorectal prostate MR image quality using PI-QUAL: A multidisciplinary team approach.

PURPOSE: To evaluate the utility of the PI-QUAL score in assessing protocol changes aimed to improve image quality from a non-endorectal coil prostate MR imaging protocol during a 9-month quality improvement (QI) project and to quantify the inter-reader agreement of PI-QUAL scores between radiologists, technologists, and physicists. METHODS: This retrospective study audited 1,012 multiparametric prostate MRI examinations as part of a national QI project according to the PI-QUAL standard. PI-QUAL scores were used to inform MR protocol changes. Following the project, 4 radiologists, 2 technologists, and 1 medical physicist collectively audited an additional set of 150 examinations to identify statistical improvements in image quality using the two-tailed Wilcoxon rank sum test. The improvements due to individual protocol changes were assessed among subsets of the 1,012 examinations which compared examinations occurring before and after the isolated protocol change. Inter-reader variability was assessed using the percent majority agreement and the average standard deviation of PI-QUAL scores between evaluators. RESULTS: During this QI project, PI-QUAL scores improved from 3.67 ± 0.75 to 4.16 ± 0.59 (p < 0.01) after implementing a series of protocol changes. Among a subset of 451 cases, we found that adopting R/L rather than A/P phase encoding reduced distortion in diffusion-weighted imaging (DW) from 21.6% (41/190 A/P phase encoded cases) to 11.5% (30/261 R/L phase encoded cases) (p < 0.01). Similarly, in the same 451 cases, adopting R/L phase encoding in T2WI reduced breathing motion artifacts from 34.6% (94/272 A/P phase encoding cases) to 12.8% (23/179 R/L phase encoding cases) (p < 0.01). DWI wraparound artifact was mitigated by employing a full-pelvis shim and enabling the abdomen shim option. The occurrence of low signal-to-noise ratio was reduced from 19.4% (19/98 cases without a weight-based threshold) to 6.3% (10/160) by instituting a weight-based threshold for using an endorectal coil (p < 0.01). The percent majority agreement was similar between radiologists, technologists and physicists, and all evaluators combined (72%, 77%, and 67%, respectively). CONCLUSIONS: PI-QUAL can evaluate image quality changes resulting from protocol optimizations at both the exam- and series-levels. With training, radiologists, technologists, and physicists can perform PI-QUAL scoring with similar performance. Broadening the scope of the quality improvement team can result in meaningful and lasting change.

Relationship Between Pretreatment Body Composition and Clinical Outcomes in Patients With Metastatic Renal Cell Carcinoma Receiving First-Line Ipilimumab Plus Nivolumab.

INTRODUCTION: Biomarkers are needed to identify patients with metastatic renal cell carcinoma (mRCC) most likely to benefit from immune checkpoint inhibitors. We examined associations between radiographically assessed body composition (BC) variables and body mass index (BMI) with clinical outcomes for patients with mRCC receiving first-line ipilimumab + nivolumab (ipi/nivo). PATIENTS AND METHODS: We retrospectively reviewed all patients with mRCC treated with first-line ipi/nivo at one institution before June 1, 2021 with an analyzable baseline computed tomography (CT) scan. BC variables (skeletal muscle index [SMI], subcutaneous adipose tissue index [SATI], and visceral adipose tissue index [VATI]) were measured using baseline CT scans. Relationships between BC variables and clinical outcomes were examined using Cox proportional hazard regression models. RESULTS: Ninety-nine patients were analyzed (74% male, 64% overweight/obese, 75% low SMI). Controlling for age, IMDC risk, and sex (for BMI analyses), high vs. low SMI (HR=2.433, CI: 1.397-4.238, P=.0017), high vs. low SATI (HR=1.641, CI: 1.023-2.632, P=.0398), and obese BMI (≥ 30 kg/m2) vs. normal/overweight BMI (<30 kg/m2) (HR=1.859, CI: 1.156-2.989, P=.0105) were significantly associated with progression-free survival (PFS). Median overall survival (OS) for low SMI patients was higher (42.74 months, CI: 26.84, NR) than median OS for high SMI patients (27.01 months, CI: 15.28, NR) (adjusted HR=1.728, CI: 0.909-3.285, P=.0952). No BC variables were significantly associated with OS or objective response rate. CONCLUSIONS: Low SMI and low SATI were associated with significantly better PFS for patients with mRCC receiving first-line ipi/nivo. Radiographic BC variables may be useful prognostic biomarkers in this setting.

Reconciling discordance between PI-RADS 4 lesions and targeted biopsy: Early experience of a multidisciplinary quality improvement protocol with PI-RADS 4 subcategorization.

PURPOSE: PI-RADS 4 lesions are considered to have a "high" likelihood of clinically-significant prostate cancer (csPCa). However, patients undergoing targeted biopsy have a range of histologic findings. Understanding discordant cases is critical to improve diagnostic accuracy and inform subsequent management. We studied early findings from implementation of a multidisciplinary Quality Improvement (QI) protocol for reconciling discordance and evaluate the potential heterogeneity of PI-RADS 4. METHODS: Patients with mpMRI PI-RADS 4 lesions undergoing fusion-targeted biopsy from January 2017 to May 2021 were retrospectively reviewed. The discordant targeted biopsy pathology (benign/GG1) was evaluated utilizing a QI protocol and all lesions were subcategorized based on ADC values. Positive Predictive Value (PPV) for PI-RADS 4 lesions overall and the Cancer Detection Rate (CDR) for subcategorized lesions were calculated. RESULTS: 248 patients with 286 lesions were reviewed. Prior to re-review, PI-RADS 4 PPV for ≥ GG1 and ≥ GG2 lesions were 0.55 and 0.34, increasing to 0.67 and 0.43 following reconciliation. Lesion subcategorization based on ADC value as higher suspicion (4+) and lower suspicion (4-) resulted in 158 and 117 lesions, with reverse-fusion analysis revealing that 61% and 17% of lesions contained csPCa, respectively. Subgroup analysis among PI-RADS 4+ lesions led to an increase in the CDR to 75% and 61% for ≥ GG1 and ≥ GG2. CONCLUSION: Use of multidisciplinary QI protocol to review discordance cases of PI-RADS 4 improves diagnostic accuracy and guides subsequent management. Our findings highlight the known heterogeneity of this category with reference to csPCa CDR, suggesting the potential value of PI-RADS 4 subcategorization.

American College of Radiology initiatives on prostate magnetic resonance imaging quality.

Magnetic resonance imaging (MRI) has become integral to diagnosing and managing patients with suspected or confirmed prostate cancer. However, the benefits of utilizing MRI can be hindered by quality issues during imaging acquisition, interpretation, and reporting. As the utilization of prostate MRI continues to increase in clinical practice, the variability in MRI quality and how it can negatively impact patient care have become apparent. The American College of Radiology (ACR) has recognized this challenge and developed several initiatives to address the issue of inconsistent MRI quality and ensure that imaging centers deliver high-quality patient care. These initiatives include the Prostate Imaging Reporting and Data System (PI-RADS), developed in collaboration with an international panel of experts and members of the European Society of Urogenital Radiology (ESUR), the Prostate MR Image Quality Improvement Collaborative, which is part of the ACR Learning Network, the ACR Prostate Cancer MRI Center Designation, and the ACR Appropriateness Criteria. In this article, we will discuss the importance of these initiatives in establishing quality assurance and quality control programs for prostate MRI and how they can improve patient outcomes.

ACR Appropriateness Criteria® Staging of Renal Cell Carcinoma: 2022 Update.

Renal cell carcinoma is a complex group of highly heterogenous renal tumors demonstrating variable biological behavior. Pretreatment imaging of renal cell carcinoma involves accurate assessment of the primary tumor, presence of nodal, and distant metastases. CT and MRI are the key imaging modalities used in the staging of renal cell carcinoma. Important imaging features that impact treatment include tumor extension into renal sinus and perinephric fat, involvement of pelvicalyceal system, infiltration into adrenal gland, involvement of renal vein and inferior vena cava, as well as the presence of metastatic adenopathy and distant metastases. 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.

Patient-reported functional outcomes and oncological control after primary focal cryotherapy for clinically significant prostate cancer: A Phase II mandatory biopsy-monitored study.

INTRODUCTION: We report herein the impact of focal therapy (FT) on multi-domain functional outcomes in a Phase II prospective clinical trial (NCT04138914) in focal cryotherapy for clinically significant prostate cancer (csPCa). METHODS: The primary outcome was the detection of a ≥5 point deterioration in any of the four main expanded prostate index composite (EPIC) functional domains. Pretreatment multiparametric magnetic resonance imaging (mpMRI) and transperineal targeted and systematic saturation biopsy were used to select patients with prostate-specific antigen (PSA)≤20 ng/mL, Gleason grade group (GG) ≤4, mpMRI lesion volume ≤ 3 mL (for a single lesion) or ≤1.5 mL (where two lesions were present). Focal cryotherapy was performed with a minimum 5 mm margin around each target lesion. EPIC scores were obtained at baseline and posttreatment at 1, 3, 6, and 12 months. Mandatory repeat mpMRI and prostate biopsy were performed at 12 months to determine the infield and outfield recurrence. RESULTS: Twenty-eight patients were recruited. The mean age was 68 years, with PSA of 7.3 ng/mL and PSA density of 0.19 ng/mL2 . No Clavien-Dindo ≥3 complications occurred. Transient worsening of EPIC urinary (mean diff 16.0, p < 0.001, 95% confidence interval [CI]: 8.8-23.6) and sexual function scores (mean diff 11.0, p:0.005, 95% CI: 4.0-17.7) were observed at 1-month posttreatment, with recovery by Month 3. A subgroup who had ablation extending to the neurovascular bundle had a trend to delayed recovery of sexual function to Month 6. At 12-month repeat mpMRI and biopsy, 22 patients (78.6%) had no detectable csPCa. Of the six patients (21.4%) who had csPCa recurrences, four were GG2, one GG3, and one GG4. Four patients underwent repeat FT, one underwent radical prostatectomy, while the remaining one patient with low-volume GG2 cancer opted for active surveillance. CONCLUSION: FT using cryotherapy was associated with a transient deterioration of urinary and sexual function with resolution at 3 months posttreatment and with reasonable early efficacy in well-selected csPCa patients.

A Faster Prostate MRI: Comparing a Novel Denoised, Single-Average T2 Sequence to the Conventional Multiaverage T2 Sequence Regarding Lesion Detection and PI-RADS Score Assessment.

BACKGROUND: The T2 w sequence is a standard component of a prostate MRI examination; however, it is time-consuming, requiring multiple signal averages to achieve acceptable image quality. PURPOSE/HYPOTHESIS: To determine whether a denoised, single-average T2 sequence (T2 -R) is noninferior to the standard multiaverage T2 sequence (T2 -S) in terms of lesion detection and PI-RADS score assessment. STUDY TYPE: Retrospective. POPULATION: A total of 45 males (age range 60-75 years) who underwent clinically indicated prostate MRI examinations, 21 of whom had pathologically proven prostate cancer. FIELD STRENGTH/SEQUENCE: A 3 T; T2 w FSE, DWI with ADC maps, and dynamic contrast-enhanced images with color-coded perfusion maps. T2 -R images were created from the raw data utilizing a single "average" with iterative denoising. ASSESSMENT: Nine readers randomly assessed complete exams including T2 -R and T2 -S images in separate sessions. PI-RADS version 2.1 was used. All readers then compared the T2 -R and T2 -S images side by side to evaluate subjective preference. An additional detailed image quality assessment was performed by three senior level readers. STATISTICAL TESTS: Generalized linear mixed effects models for differences in lesion detection, image quality features, and overall preference between T2 -R and T2 -S sequences. Intraclass correlation coefficients (ICC) were used to assess reader agreement for all comparisons. A significance threshold of P = 0.05 was used for all statistical tests. RESULTS: There was no significant difference between sequences regarding identification of lesions with PI-RADS ≥3 (P = 0.10) or PI-RADS score (P = 0.77). Reader agreement was excellent for lesion identification (ICC = 0.84). There was no significant overall preference between the two sequences regarding image quality (P = 0.07, 95% CI: [-0.23, 0.01]). Reader agreement was good regarding sequence preference (ICC = 0.62). DATA CONCLUSION: Use of single-average, denoised T2 -weighted images was noninferior in prostate lesion detection or PI-RADS scoring when compared to standard multiaverage T2 -weighted images. EVIDENCE LEVEL: 3. TECHNICAL EFFICACY: Stage 3.

Utility of a Rule-Based Algorithm in the Assessment of Standardized Reporting in PI-RADS.

RATIONALE AND OBJECTIVES: Adoption of the Prostate Imaging Reporting & Data System (PI-RADS) has been shown to increase detection of clinically significant prostate cancer on prostate mpMRI. We propose that a rule-based algorithm based on Regular Expression (RegEx) matching can be used to automatically categorize prostate mpMRI reports into categories as a means by which to assess for opportunities for quality improvement. MATERIALS AND METHODS: All prostate mpMRIs performed in the Duke University Health System from January 2, 2015, to January 29, 2021, were analyzed. Exclusion criteria were applied, for a total of 5343 male patients and 6264 prostate mpMRI reports. These reports were then analyzed by our RegEx algorithm to be categorized as PI-RADS 1 through PI-RADS 5, Recurrent Disease, or "No Information Available." A stratified, random sample of 502 mpMRI reports was reviewed by a blinded clinical team to assess performance of the RegEx algorithm. RESULTS: Compared to manual review, the RegEx algorithm achieved overall accuracy of 92.6%, average precision of 88.8%, average recall of 85.6%, and F1 score of 0.871. The clinical team also reviewed 344 cases that were classified as "No Information Available," and found that in 150 instances, no numerical PI-RADS score for any lesion was included in the impression section of the mpMRI report. CONCLUSION: Rule-based processing is an accurate method for the large-scale, automated extraction of PI-RADS scores from the text of radiology reports. These natural language processing approaches can be used for future initiatives in quality improvement in prostate mpMRI reporting with PI-RADS.

Initial Longitudinal Outcomes of Risk-Stratified Men in Their Forties Screened for Prostate Cancer Following Implementation of a Baseline Prostate-Specific Antigen.

PURPOSE: Prostate cancer (PCa) screening can lead to potential over-diagnosis/over-treatment of indolent cancers. There is a need to optimize practices to better risk-stratify patients. We examined initial longitudinal outcomes of mid-life men with an elevated baseline prostate-specific antigen (PSA) following initiation of a novel screening program within a system-wide network. MATERIALS AND METHODS: We assessed our primary care network patients ages 40 to 49 years with a PSA measured following implementation of an electronic health record screening algorithm from 2/2/2017-2/21/2018. The multidisciplinary algorithm was developed taking factors including age, race, family history, and PSA into consideration to provide a personalized approach to urology referral to be used with shared decision-making. Outcomes of men with PSA ≥1.5 ng/mL were evaluated through 7/2021. Statistical analyses identified factors associated with PCa detection. Clinically significant PCa (csPCa) was defined as Gleason Grade Group (GGG) ≥2 or GGG1 with PSA ≥10 ng/mL. RESULTS: The study cohort contained 564 patients, with 330 (58.5%) referred to urology for elevated PSA. Forty-nine (8.7%) underwent biopsy; of these, 20 (40.8%) returned with PCa. Eleven (2.0% of total cohort and 55% of PCa diagnoses) had csPCa. Early referral timing (odds ratio [OR], 4.58) and higher PSA (OR, 1.07) were significantly associated with PCa at biopsy on multivariable analysis (both p<0.05), while other risk factors were not. Referred patients had higher mean PSAs (2.97 vs. 1.98, p=0.001). CONCLUSIONS: Preliminary outcomes following implementation of a multidisciplinary screening algorithm identified PCa in a small, important percentage of men in their forties. These results provide insight into baseline PSA measurement to provide early risk stratification and detection of csPCa in patients with otherwise extended life expectancy. Further follow-up is needed to possibly determine the prognostic significance of such mid-life screening and optimize primary care physician-urologist coordination.

ACR Appropriateness Criteria® Acute Pyelonephritis: 2022 Update.

Acute pyelonephritis (APN) is a severe urinary tract infection (UTI) that has the potential to cause sepsis, shock, and death. In the majority of patients, uncomplicated APN is diagnosed clinically and is responsive to treatment with appropriate antibiotics. In patients who are high risk or when treatment is delayed, microabscesses may coalesce to form an acute renal abscess. High-risk patients include those with a prior history of pyelonephritis, lack of response to therapy for lower UTI or for APN, diabetes, anatomic or congenital abnormalities of the urinary system, infections by treatment-resistant organisms, nosocomial infection, urolithiasis, renal obstruction, prior renal surgery, advanced age, pregnancy, renal transplant recipients, and immunosuppressed or immunocompromised patients. Pregnant patients and patients with renal transplants on immunosuppression are at an elevated risk of severe complications. Imaging studies are often requested to aid with the diagnosis, identify precipitating factors, and differentiate lower UTI from renal parenchymal involvement, particularly in high-risk individuals. Imaging is usually not appropriate for the first-time presentation of suspected APN in an uncomplicated patient. The primary imaging modalities used in high-risk patients with suspected APN are CT, MRI, and ultrasound, although CT was usually not appropriate for initial imaging in a pregnant patient with no other complications. The ACR 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 in which peer-reviewed literature is lacking or equivocal, experts may be the primary evidentiary source available to formulate a recommendation.

Evaluation of tumor microenvironment and biomarkers of immune checkpoint inhibitor response in metastatic renal cell carcinoma.

BACKGROUND: Immunotherapy combinations including ipilimumab and nivolumab are now the standard of care for untreated metastatic renal cell carcinoma (mRCC). Biomarkers of response are lacking to predict patients who will have a favorable or unfavorable response to immunotherapy. This study aimed to use the OmniSeq transcriptome-based platform to develop biomarkers of response to immunotherapy. METHODS: Two cohorts of patients were retrospectively collected. These included an investigational cohort of patients with mRCC treated with immune checkpoint inhibitor therapy from five institutions, and a subsequent validation cohort of patients with mRCC treated with combination ipilimumab and nivolumab from two institutions (Duke Cancer Institute and Cleveland Clinic Taussig Cancer Center). Tissue-based RNA sequencing was performed using the OmniSeq Immune Report Card on banked specimens to identify gene signatures and immune checkpoints associated with differential clinical outcomes. A 5-gene expression panel was developed based on the investigational cohort and was subsequently evaluated in the validation cohort. Clinical outcomes including progression-free survival (PFS) and overall survival (OS) were extracted by retrospective chart review. Objective response rate (ORR) was assessed by Response Evaluation Criteria in Solid Tumors (RECIST) V.1.1. RESULTS: The initial investigation cohort identified 86 patients with mRCC who received nivolumab (80%, 69/86), ipilimumab/nivolumab (14%, 12/86), or pembrolizumab (6%, 5/86). A gene expression score was created using the top five genes found in responders versus non-responders (FOXP3, CCR4, KLRK1, ITK, TIGIT). The ORR in patients with high gene expression (GEhigh) on the 5-gene panel was 29% (14/48), compared with low gene expression (GElow) 3% (1/38, χ2 p=0.001). The validation cohort was comprised of 62 patients who received ipilimumab/nivolumab. There was no difference between GEhigh and GElow in terms of ORR (44% vs 38.5%), PFS (HR 1.5, 95% CI 0.58 to 3.89), or OS (HR 0.96, 95% CI 0.51 to 1.83). Similarly, no differences in ORR, PFS or OS were observed when patients were stratified by tumor mutational burden (high=top 20%), PD-L1 (programmed death-ligand 1) expression by immunohistochemistry or RNA expression, or CTLA-4 (cytotoxic T-lymphocytes-associated protein 4) RNA expression. The International Metastatic RCC Database Consortium (IMDC) risk score was prognostic for OS but not PFS. CONCLUSION: A 5-gene panel that was associated with improved ORR in a predominantly nivolumab monotherapy population of patients with mRCC was not predictive for radiographic response, PFS, or OS among patients with mRCC treated with ipilimumab and nivolumab.

Reconciling Discordance Between Prostate Biopsy Histology and Magnetic Resonance Imaging Suspicion - Implementation of a Quality Improvement Protocol of Imaging Re-review and Reverse-fusion Target Analysis.

There is uncertainty with how to proceed when targeted prostate biopsy of suspicious multiparametric magnetic resonance imaging (mpMRI) lesions return without clinically significant prostate cancer (csPCa). While possible, there are error sources that could contribute to such discordance including the mpMRI read, mpMRI-ultrasound fusion, biopsy technique, and histologic classification. Consequences are potentially significant; mistakenly missing csPCa can lead to delays in curative treatment. Conversely, in cases of incorrect mpMRI interpretation, the patient may be subjected to unnecessary workup/burden. At our institution, we implemented a quality improvement (QI) initiative triggered after a discordant case occurs. This multidisciplinary review process incorporates mpMRI re-review and assessment of accurate lesion-sampling, termed "reverse-fusion." Herein, we describe the protocol, present sample cases, and discuss clinical implications.

Structured approach to resolving discordance between PI-RADS v2.1 score and targeted prostate biopsy results: an opportunity for quality improvement.

BACKGROUND: Prostate multiparametric magnetic resonance imaging (mpMRI) can identify lesions within the prostate with characteristics identified in Prostate Imaging Reporting and Data System (PI-RADS) v2.1 associated with clinically significant prostate cancer (csPCa) or Gleason grade group (GGG) ≥ 2 at biopsy. OBJECTIVE: To assess concordance (PI-RADS 5 lesions with csPCa) of PI-RADS v2/2.1 with targeted, fusion biopsy results and to examine causes of discordance (PI-RADS 5 lesions without csPCa) with aim to provide a structured approach to resolving discordances and develop quality improvement (QI) protocols. METHODS: A retrospective study of 392 patients who underwent mpMRI at 3 Tesla followed by fusion biopsy. PI-RADS v2/2.1 scores were assigned to lesions identified on mpMRI and compared to biopsy results expressed as GGG. Positive predictive value (PPV) of PI-RADS v2/2.1 was calculated for all prostate cancer and csPCa. Discordant cases were re-reviewed by a radiologist with expertise in prostate mpMRI to determine reason for discordance. RESULTS: A total of 521 lesions were identified on mpMRI. 121/521 (23.2%), 310/524 (59.5%), and 90/521 (17.3%) were PI-RADS 5, 4, and 3, respectively. PPV of PI-RADS 5, 4, and 3 for all PCa and csPCa was 0.80, 0.55, 0.24 and 0.63, 0.33, and 0.09, respectively. 45 cases of discordant biopsy results for PI-RADS 5 lesions were found with 27 deemed "true" discordances or "unresolved" discordances where imaging re-review confirmed PI-RADS appropriateness, while 18 were deemed "false" or resolved discordances due to downgrading of PI-RADS scores based on imaging re-review. Adjusting for resolved discordances on re-review, the PPV of PI-RADS 5 lesions for csPCa was deemed to be 0.74 and upon adjusting for presence of csPCa found in cases of unresolved discordance, PPV rose to 0.83 for PI-RADS 5 lesions. CONCLUSION: Although PIRADS 5 lesions are considered high risk for csPCa, the PPV is not 100% and a diagnostic dilemma occurs when targeted biopsy returns discordant. While PI-RADS score is downgraded in some cases upon imaging re-review, a number of "false" or "unresolved" discordances were identified in which MRI re-review confirmed initial PI-RADS score and subsequent pathology confirmed presence of csPCa in these lesions. CLINICAL IMPACT: We propose a structured approach to resolving discordant biopsy results using multi-disciplinary re-review of imaging and archived biopsy strikes as a quality improvement pathway. Further work is needed to determine the value of re-biopsy in cases of unresolved discordance and to develop robust QI systems for prostate MRI.

Automated versus manual analysis of body composition measures on computed tomography in patients with bladder cancer.

PURPOSE: Manual measurement of body composition on computed tomography (CT) is time-consuming, limiting its clinical use. We validate a software program, Automatic Body composition Analyzer using Computed tomography image Segmentation (ABACS), for the automated measurement of body composition by comparing its performance to manual segmentation in a cohort of patients with bladder cancer. METHOD: We performed a retrospective analysis of 285 patients treated for bladder cancer at the Duke University Health System from 1996 to 2017. Abdominal CT images were manually segmented at L3 using Slice-O-Matic. Automated segmentation was performed with ABACS on the same L3-level images. Measures of interest were skeletal muscle (SM) area, subcutaneous adipose tissue (SAT) area, and visceral adipose tissue (VAT) area. SM index, SAT index, and VAT index were calculated by dividing component areas by patient height2 (m2). Patients were dichotomized as sarcopenic, having excessive subcutaneous fat, or having excessive visceral fat using published cut-off values. Agreement between manual and automated segmentation was assessed using the Pearson product-moment correlation coefficient (PPMCC), the interclass correlation coefficient (ICC3), and the kappa statistic (κ). RESULTS: There was strong agreement between manual and automatic segmentation, with PPMCCs > 0.90 and ICC3s > 0.90 for SM, SAT, and VAT areas. Categorization of patients as sarcopenic (κ = 0.73), having excessive subcutaneous fat (κ = 0.88), or having excessive visceral fat (κ = 0.90) displayed high agreement between methods. CONCLUSIONS: Automated segmentation of body composition measures on CT using ABACS performs similarly to manual analysis and may expedite data collection in body composition research.

Prostate MRI Qualification: AJR Expert Panel Narrative Review.

Prostate MRI is now established as a first-line investigation for individuals presenting with suspected localized or locally advanced prostate cancer. Successful delivery of the MRI-directed pathway for prostate cancer diagnosis relies on high-quality imaging as well as the interpreting radiologist's experience and expertise. Radiologist certification in prostate MRI may help limit interreader variability, optimize outcomes, and provide individual radiologists with documentation of meeting predefined standards. This AJR Expert Panel Narrative Review summarizes existing certification proposals, recognizing variable progress across regions in establishing prostate MRI certification programs. To our knowledge, Germany is the only country with a prostate MRI certification process that is currently available for radiologists. However, prostate MRI certification programs have also recently been proposed in the United States and United Kingdom and by European professional society consensus panels. Recommended qualification processes entail a multifaceted approach, incorporating components such as minimum case numbers, peer learning, course participation, continuing medical education credits, and feedback from pathology results. Given the diversity in health care systems, including in the provision and availability of MRI services, national organizations will likely need to take independent approaches to certification and accreditation. The relevant professional organizations should begin developing these programs or continue existing plans for implementation.