Lung uptake detected by 68Ga-PSMA-11 PET/CT in prostate cancer patients with SARS-CoV-2: a case series.

Coronavirus disease 2019 (COVID-19) pathology is associated with neoangiogenesis and interstitial pneumonia. 68Ga-PSMA-11-PET/CT is able to image in vivo PSMA (Prostate-Specific Membrane Antigen) expression on both prostate cancer (PCa) cells and neovasculature endothelial cells. The aim of the case series was to explore pulmonary PSMA expression not related to cancer in patients with PCa and concomitant COVID-19. In this retrospective, multicenter case series, patients who underwent 68Ga-PSMA-11-PET/CT for PCa and concomitant proven COVID-19 infection were analyzed. Patients were stratified according to 68Ga-PSMA-11 intensity of uptake in the lung (SUVmax). Low uptake: < blood pool; mild-to-moderate uptake: > blood pool and < liver; intense uptake: > liver. Potential correlation between pulmonary 68Ga-PSMA-11 uptake not related to PCa and CT patterns typical for COVID-19 was assessed. Nine patients were included, all of them presenting abnormal 68Ga-PSMA-11 uptake, at different grades: 2/9 low, 6/9 mild-to-moderate, 1/9 high. Uptake distribution was generally bilateral, peripheral and posterior, positively matching with ground-glass CT alterations in 7/9 (78%) patients, while mismatch was observed in 2/9 (22%). 1/9 patients presented PCa lung metastases at 68Ga-PSMA-11. 68Ga-PSMA-11-PET/CT detected increased PSMA uptake within the lung, not related to PCa, matching with CT typical COVID-19 patterns in almost all patients. Further studies are needed to evaluate the role of 68Ga-PSMA-11 PET in COVID-19 patients and the potential role of PSMA overexpression as a biomarker for neoangiogenesis, in both oncological and infective disorders.

The Contribution of Case Mix, Skill Mix and Care Processes to the Outcomes of Community Hospitals: A Population-Based Observational Study.

INTRODUCTION: Community hospitals (CHs) could address the emerging complex care needs of patients. We investigated which characteristics of patients' and CHs affect patient outcomes, in order to identify who could benefit the most from CH care and the best skill mix to deliver this care. METHODS: We analysed all elderly patients discharged from the CHs of Emilia-Romagna, Italy. CH skill mix and care processes were collected with an ad hoc survey. The primary outcome was improvement in the Barthel index (BI) on discharge. Hierarchical regression analysis was performed to test the associations under study. RESULTS: 53% of the patients had a BI improvement ≥10. After adjusting for the diverse case mix of the patients, no significant association was found between CH characteristics and BI improvement. Patient characteristics explained only a portion of the variability in CH performance. DISCUSSION: Heterogeneity in case mix reflects the nature of CHs, which play context-specific roles as integrators between primary care services and hospitals. Residual variability in BI improvement rates across CHs might be attributed to aspects of care not detected in our survey. CONCLUSIONS: More research is needed to study the impact of CH skill mix and care processes on patient outcomes.

Identification of PCWG3 Target Populations Is More Accurate and Reproducible with PSMA PET Than with Conventional Imaging: A Multicenter Retrospective Study.

Prostate-specific membrane antigen (PSMA)-ligand PET is potentially useful for screening of castration-resistant prostate cancer (CRPC) clinical trial target populations. We investigated the impact of PSMA PET on Prostate Cancer Clinical Trials Working Group 3 (PCWG3) clinical subtype classification when compared with conventional imaging (CI). Methods: A multicenter retrospective study enrolled patients who had undergone PSMA PET for CRPC, had prostate-specific antigen values of at least 1 ng/mL, and had undergone CI-that is, CT plus bone scanning or whole-body MRI. The clinical PCWG3 subtype was determined for PET versus CI by 3 masked readers. Results: Sixty-seven patients were included, and PSMA PET led to up-staging in 15% (10/67) of patients; of these, 6 of 10 (60%) had nonmetastatic CRPC on CI. PSMA PET resulted in down-staging in 15% (10/67) of patients. Agreement for PET versus CI PCWG3 clinical subtypes was 0.81 versus 0.51, 0.74 versus 0.47, 0.95 versus 0.72, or 0.59 versus 0.66 for local, nodal, bone, or visceral disease, respectively. Conclusion: Despite 70% concordance with CI, PSMA PET demonstrated superior reproducibility and accuracy especially for non-metastatic CRPC and should be implemented in future clinical trial entry procedures.

Sociodemographic and health service organizational factors associated with the choice of the private versus public sector for specialty visits: Evidence from a national survey in Italy.

INTRODUCTION: Although Italy's NHS is funded through general taxation, the private sector plays an important role in health service provision and financing. The aim of this paper was to identify the sociodemographic and health service organizational factors associated with the propensity to seek specialist care in the private sector. MATERIALS AND METHODS: Data were retrieved from the national Istat survey "Health conditions and use of health services" carried out in 2012-2013. We selected adults with a specialty visit in the previous 12 months in the four most frequent medical specialties: ophthalmology, cardiology, obstetrics/gynecology and orthopedics. The study outcome was the choice to use a private service. In order to investigate the determinants of private use, we adopted the socio-behavioral model by Andersen and Newman, making a distinction between sociodemographic and healthcare organizational factors. The associations with the outcome were analyzed using chi-squared test, t-test and multivariable logistic regression analysis. RESULTS AND DISCUSSION: Use of private care varied widely, from 26.3% for cardiology to 53.6% for obstetrics/gynecology. Females, patients with higher educational levels and patients with higher self-reported economic resources sought more frequently private healthcare for all specialties; younger patients and employed patients were more likely to seek private care for ophthalmic conditions. Exemption from copayment for public services reduced more than half the propensity to seek private care. Trust in this healthcare service was the main reason for private users (52.5%) followed by waiting time (26.7%) and physician choice (20.1%). CONCLUSION: The attitude of the population to use private services for specialist visits is linked both to sociodemographic and health services organizational factors: the former are unmodifiable while the latter are susceptible to managerial and health policy actions. In a public-financed, universal coverage system, policy makers may act upon the organizational factors that make private health facilities more attractive in order to reduce private care use.

Mapping Prostate Cancer Lesions Before and After Unsuccessful Salvage Lymph Node Dissection Using Repeat PSMA PET.

The aim of this study was to analyze patterns of persistent versus recurrent or new PET lesions in a selected patient cohort with prostate-specific antigen (PSA) persistence after salvage lymph node dissection (SLND) and pre-procedure and post-procedure prostate-specific membrane antigen (PSMA) ligand PET. Methods: Sixteen patients were included in this multicenter study. The inclusion criteria were PSMA PET performed for biochemical recurrence before SLND (pre-SLND PET) and repeat PSMA PET performed for a persistently elevated PSA level (≥0.1 ng/mL) at least 6 wk after SLND (post-SLND PET). Image analysis was performed by 3 independent nuclear medicine physicians applying the molecular imaging TNM system PROMISE. Lesions were confirmed by histopathology, presence on correlative CT/MRI/bone scanning, or PSA response after focal therapy. Results: Post-SLND PET identified prostate cancer lesions in 88% (14/16) of patients with PSA persistence after SLND. Median PSA was 1.2 ng/mL (interquartile range, 0.6-2.8 ng/mL). Disease was confined to the pelvis in 56% of patients (9/16), and most of these men had common iliac (6/16, 38%) and internal iliac lymph node metastases (6/16, 38%). Extrapelvic disease was detected in 31% of patients (5/16). In pre- and post-SLND PET comparison, 10 of 16 had at least one lesion already detected at baseline (63% PET persistence), 4 of 16 had new lesions only (25% PET recurrence), and 2 had no disease on post-SLND PET. All validated regions (11 regions in 9 patients) were true-positive. Nine of 14 (64%) patients underwent repeat local therapies after SLND (7/14 radiotherapy, 2/14 surgery). Conclusion: SLND of pelvic nodal metastases was often not complete according to PSMA PET. About two thirds of patients had PET-positive nodal disease after SLND already seen on pre-SLND PSMA PET. Notably, about one quarter of patients had new lesions, not detected by presurgical PSMA PET.

Evaluation of an Automated Module Synthesis and a Sterile Cold Kit-Based Preparation of 68Ga-PSMA-11 in Patients with Prostate Cancer.

68Ga-labeled urea-based inhibitors of the prostate-specific membrane antigen (PSMA), such as 68Ga-PSMA-11, are promising small molecules for targeting prostate cancer (PCa). Although this radiopharmaceutical was produced mostly by means of manual synthesis and automated synthesis modules, a sterile cold kit was recently introduced. The aim of our study was to evaluate the image quality of 68Ga-PSMA-11 PET/CT (PSMA-PET) in a population of PCa patients after the injection of comparable activities of 68Ga-PSMA-11 obtained with the 2 different synthetic procedures. A secondary aim was to identify secondary factors that may have an impact on image quality and, thus, final interpretation. Methods: Two different groups of 100 consecutive PCa patients who underwent PSMA-PET were included in the study. The first group of patients was imaged with 68Ga-PSMA-11 obtained using synthesis modules, whereas the second group's tracer activity was synthesized using a sterile cold kit. All PET images were independently reviewed by 2 nuclear medicine diagnosticians with at least 2 y of experience in PSMA-based imaging and unaware of the patients' clinical history. The 2 reviewers independently rated the quality of each PSMA-PET scan using a 3-point Likert-type scale. In cases of discordance, the operators together reviewed the images and reached a consensus. Performance was evaluated on the basis of the expected biodistribution, lesion detection rate, and physiologic background uptake. Results: Overall, 104 of 200 (52%) PSMA-PET scans were positive for PCa-related findings. No significant differences in image quality between cold kits and synthesis modules were found (P = 0.13), although a higher proportion of images was rated as excellent by the observers for kits than for modules (45% vs. 34%). Furthermore, after image quality had been dichotomized as excellent or not excellent, multivariate regression analysis found several factors to be significantly associated with a not-excellent quality: an increase in patient age (+5 y: odds ratio [OR], 1.40; 95% confidence interval [CI], 1.12-1.75), an increase in patient weight (+5 kg: OR, 1.89; 95% CI, 1.53-2.32), an increase in 68Ga-PSMA-11 uptake time (+10 min: OR, 1.45; 95% CI, 1.08-1.96), and a decrease in injected activity (-10 MBq: OR, 1.28; 95% CI, 1.07-1.52). Conclusion: No significant differences were identified between the 2 groups of patients undergoing PSMA-PET; therefore, we were not able to ascertain any significant influences of tracer production methodology on final scan quality. However, increased patient age, increased patient weight, decreased injected activity, and increased 68Ga-PSMA-11 uptake time were significantly associated with an overall poorer image quality.

68Ga-PSMA-11 Positron Emission Tomography Detects Residual Prostate Cancer after Prostatectomy in a Multicenter Retrospective Study.

PURPOSE: Prostate specific antigen persistence after radical prostatectomy is associated with adverse outcomes in patients with prostate cancer. We sought to define regions at risk for residual disease as well as the accuracy of prostate specific membrane antigen ligand positron emission tomography in patients with prostate specific antigen persistence. MATERIALS AND METHODS: At 6 participating centers a total of 191 patients who underwent 68Ga-prostate specific membrane antigen-11 positron emission tomography/computerized tomography or positron emission tomography/magnetic resonance imaging for persistently elevated postoperative prostate specific antigen (0.1 ng/ml or greater) were retrospectively included in study. The detection rate and the positive predictive value were determined. In 33 patients with additional prostate specific membrane antigen ligand positron emission tomography before prostatectomy we also determined the rate of positron emission tomography based persistence and recurrence. RESULTS: Prostate specific membrane antigen ligand positron emission tomography localized prostate cancer in 130 of 191 patients (68%) with prostate specific antigen persistence at a median prostate specific antigen of 1.1 ng/ml. The detection rate significantly increased with prostate specific antigen (p <0.001). Regarding prostate specific membrane antigen positron emission tomography/computerized tomography only 61 of 173 patients (35%) had disease confined to the pelvis while 57 of 173 (33%) had distant lesions. The most frequently affected nodal regions were the obturator in 42% and the presacral/mesorectal region in 40%. In 15 of the 33 patients (45%) with prostate specific membrane antigen ligand positron emission tomography before and after surgery at least 1 lesion was detected at baseline (positron emission tomography persistence), 8 (24%) had new lesions (positron emission tomography recurrence) and 10 (30%) had negative positron emission tomography findings. The positive predictive value of prostate specific membrane antigen ligand positron emission tomography was 91%. Systemic therapy initiation was significantly associated with distant lesions on prostate specific membrane antigen ligand positron emission tomography. CONCLUSIONS: Prostate specific membrane antigen ligand positron emission tomography localized prostate cancer in more than two-thirds of patients with high risk features and prostate specific antigen persistence after prostatectomy. Obturator and presacral/mesorectal nodes are at high risk for persistent metastasis.

Validation of the Italian version of the Patient Reported Experience Measures for intermediate care services.

BACKGROUND: Intermediate care (IC) services are a key component of integrated care for elderly people, providing a link between hospital and home through provision of rehabilitation and health and social care. The Patient Reported Experience Measures (PREMs) are designed to measure user experience of care in IC settings. OBJECTIVE: To examine the feasibility and the scaling properties of the Italian version of PREMs questionnaires for use in IC services. METHODS: A cross-sectional survey was conducted on consecutive users of 1 home-based and 4 bed-based IC services in Emilia-Romagna (Italy). The main outcome measure was the PREMs questionnaire results. PREMs for each home- and bed-based IC services were translated, back-translated, and adapted through consensus among the members of the advisory board and pilot testing of face validity in 15 patients. A total of 199 questionnaires were returned from users of bed-based services and 185 were returned by mail from users of home-based services. The return rates and responses were examined. Mokken analysis was used to examine the scaling properties of the PREMs. RESULTS: Analysis performed on the bed-based PREMs (N=154) revealed that 13 items measured the same construct and formed a moderate-strength scale (Loevinger H=0.488) with good reliability (Cronbach's alpha =0.843). Analysis of home-based PREMs (N=134 records) revealed that 15 items constituted a strong scale (Loevinger H=0.543) with good reliability (Cronbach's alpha =0.875). CONCLUSION: The Italian versions of the bed- and home-based IC-PREMs questionnaires proved to be valid and reliable tools to assess patients' experience of care. Future plans include monitoring user experience over time in the same facilities and in other Italian IC settings for between-service benchmarking.