Impact of Baseline Renal Insufficiency on Piflufolastat F-18 Performance and Investigation of Changes in Renal Function Following Piflufolastat F-18 Administration: Results From the OSPREY Trial.

INTRODUCTION: Piflufolastat F-18, a prostate-specific membrane antigen (PSMA)-targeted radiopharmaceutical, is predominantly eliminated via urinary excretion, and the kidneys have one of the highest absorbed doses. Therefore, this subgroup analysis aimed to investigate the impact of piflufolastat F-18 on renal function and its diagnostic performance in patients stratified by baseline renal function. PATIENTS AND METHODS: The OSPREY clinical trial enrolled 2 cohorts: A-high-risk patients undergoing radical prostatectomy with pelvic lymphadenectomy, and B-patients with suspected recurrent/metastatic prostate cancer on conventional imaging. Baseline estimated glomerular filtration rates were calculated, and patients were stratified by baseline chronic kidney disease (CKD) stage. Changes in serum creatinine within 28 days postdose and diagnostic performance of piflufolastat F-18 were assessed for each CKD stage group in both cohorts. RESULTS: 385 patients (cohort A, n = 268; cohort B, n = 117) underwent piflufolastat F-18-PET/CT. Baseline and postpiflufolastat F-18 median creatinine levels (mg/dL) were similar for patients in cohort A (0.95 [n = 264] vs. 0.95 [n = 252], respectively) and cohort B (0.93 [n = 116] vs. 0.96 [n = 84], respectively). Among 332 men (cohort A, n = 249; cohort B, n = 83) with baseline and postpiflufolastat creatinine measurements, there were minimal changes in creatinine across all baseline CKD stage groups (median change ranged from -0.02 to 0.023 in groups with >1 patient). The diagnostic performance of piflufolastat F-18 showed no meaningful differences when stratified by baseline CKD stage. CONCLUSION: Piflufolastat F-18 appears to be safe and effective for imaging prostate cancer, including men with mild/moderate renal insufficiency.

Osteosarcoma and Langerhans Cell Histiocytosis in a Pediatric Patient with Lynch Syndrome: A Case Report.

CASE: Lynch syndrome (hereditary nonpolyposis colorectal cancer) is associated with extracolonic manifestations, but skeletal tumors are rare. Our patient, a 12-year-old boy with Lynch syndrome, developed osteosarcoma of the left femur. Treatment included cytotoxic chemotherapy, wide resection, and pembrolizumab. Two years later, he developed an aggressive lesion in the contralateral femur that was thought to be metastatic osteosarcoma but which histology revealed to be Langerhans cell histiocytosis. CONCLUSION: This case underscores the importance of advanced testing in patients with osteosarcoma and poor response to chemotherapy, and of tissue sampling when patients with a primary malignancy develop new bone lesions. LEVEL OF EVIDENCE: IV.

Magnet Aspiration Into the Distal Lung of a Pediatric Patient: A Case Report.

Foreign body (FB) aspiration is one of the most common life-threatening emergencies in children and one of the leading causes of mortality in the pediatric population. Most commonly, aspirated items are organic materials, such as nuts and seeds. Inorganic objects are usually plastic or metal. Symptoms of aspiration can vary depending on the location, area and amount of blockage, and object size and shape. Because of the difficult airway anatomy of children, a multidisciplinary approach - including otolaryngology, pulmonology, anesthesia, and general surgery - for the removal of airway FBs is necessary and prudent to avoid more invasive surgical involvement. This report discusses a nine-year-old male who aspirated two ball magnets, which became lodged in his tracheobronchial tree and required a multidisciplinary approach for removal.

Feasibility of a nurse-led, mHealth-assisted, and team-based collaborative care model for heart failure care in India: Findings from a multi-stakeholder qualitative study.

Background: Heart failure (HF) management is often challenging due to poor adherence to GDMT and self-care. Continuous monitoring of patients by a dedicated care manager may enhance adherence to self-care and treatment and prevent hospitalisations. For the adoption and acceptance of a collaborative care model (CCM) for HF management in Indian settings, understanding the perspectives of all stakeholders regarding its various components and feasibility is needed. Therefore, we aimed to obtain perceptions of potential challenges to care and suggestions on multiple components of the proposed CCM in managing HF and its feasibility. Methods: In-depth interviews were done among HF patients, caregivers, nurses, and cardiologists from private, co-operative, and public sector tertiary care hospital settings that cater to HF patients in Kerala, India. An in-depth interview guide was used to elicit the data. Data were analysed using Python QualCoder version 2.2. We used a framework method for the analysis of data. Results: A total of 22 in-depth interviews were conducted. We found that the existing care for HF in many settings was inadequate for continuous engagement with the patients. Non-adherence to treatment and other self-care measures, was noted as a major challenge to HF care. Healthcare providers and patients felt nurses were better at leading collaborative care. However, various barriers, including technical and technological, and the apprehensions of nurses in leading the CCM were identified. The stakeholders also identified the mHealth-assisted CCM as a potential tool to save money. The stakeholders also appreciated the role of nurses in creating confidence in patients. Conclusions: A nurse-led, mHealth-assisted, and team-based collaborative care was recognised as an excellent step to improve patient adherence. Effective implementation of it could reduce hospitalisations and improve patients' ability to manage their HF symptoms.

Heart failure (HF) management requires continuous monitoring of patients by a dedicated care manager to improve adherence to self-care and treatment and prevent hospitalisations. In this study, we aimed to obtain perceptions of patients, carers, cardiologist and nurses on the current challenges to HF care. We also elicited the feasibility of a proposed nurse-led team based collaborative care model in managing HF with mHealth assistance and their suggestions on various components in the model. By interviewing 22 heart failure stakeholders we found the various individual, system level challenges in HF care. Non-adherence to treatment and other self-care measures, was mentioned as a major challenge to HF care. To address the challenges, healthcare providers and patients felt nurses can lead the collaborative care. The stakeholders also identified the mHealth-assisted collaborative care model (CCM) can save money by avoiding unnecessary travel for the patients. While the stakeholders appreciated the role of nurses in creating confidence in patients, they also highlighted the challenges in implementing the intervention. In order to overcome these challenges, training nurses on the basics of HF medications, their side effects, and contraindications was suggested. The stakeholders also mentioned various technical and technological barriers in the use of mHealth application.

Top Ten Tips Palliative Care Clinicians Should Know About Designing a Clinical Trial in Palliative Care.

The palliative care field is experiencing substantive growth in clinical trial-based research. Randomized controlled trials provide the necessary rigor and conditions for assessing a treatment's efficacy in a controlled population. It is therefore important that a trial is meticulously designed from the outset to ensure the integrity of the ultimate results. In this article, our team discusses ten tips on clinical trial design drawn from collective experiences in the field. These ten tips cover a range of topics that can prove challenging in trial design, from developing initial methodologies to planning sample size and powering the trial, as well as collaboratively navigating the ethical issues of trial initiation and implementation as a cohesive team. We aim to help new researchers design sound trials and continue to grow the evidence base for our specialty. The guidance provided here can be used independently or in addition to the ten tips provided by this team in a separate article focused on what palliative care clinicians should know about interpreting a clinical trial.

Top Ten Tips Palliative Care Clinicians Should Know About Interpreting a Clinical Trial.

Evidence-based practice is foundational to high-quality palliative care delivery. However, the clinical trials that compose the evidence base are often methodologically imperfect. Applying their conclusions without critical application to the clinical practice context can harm patients. The tips provided can help clinicians infer judiciously from clinical trial results and avoid credulously accepting findings without critique. We suggest that statistical and mathematical expertise is unnecessary, but rather a keen curiosity about investigators' rationale for certain design choices and how these choices can affect results is key. For a more comprehensive understanding of clinical trials, this article can be used with the authors' corresponding ten tips article that focuses on designing a clinical trial.

Patient-reported use of pancreatic enzyme replacement treatment (PERT) in pancreatic cancer in New Zealand and Australia: a cross-sectional survey study.

PURPOSE: This study investigated pancreatic enzyme replacement therapy (PERT) use in people diagnosed with pancreatic cancer in New Zealand (NZ) and Australia (AU). METHODS: A cross-sectional survey study was conducted using a mixed-media campaign to recruit people with pancreatic cancer and collect information about current PERT use. The questionnaire gathered data on participant demographics, awareness of PERT, prescribing practices and efficacy of enzyme replacement. RESULTS: Over 300 people with pancreatic cancer were recruited, 135 from New Zealand and 199 from Australia. Every region, state and territory was represented except for the West Coast (NZ) and the Northern Territory (AU), the lowest populated areas in both countries. In New Zealand, 60% of participants had heard about PERT, compared to 69.3% in Australia. Dosing regimens were inconsistent in both countries, with 18% and 27% of participants being prescribed PERT considered best practice in New Zealand and Australia, respectively. Before PERT commencement, 70% of participants experienced symptoms of malabsorption, with all symptoms improving after therapy was established. The majority of participants were compliant with their medication. CONCLUSION: PERT use in pancreatic cancer in New Zealand and Australia was highly variable and not compliant with international guidelines in which PERT is recommended as standard therapy. Enzyme replacement is effective for improving the symptoms of malabsorption in patients with pancreatic cancer. Clinician education may be needed to help improve the use of PERT in people with pancreatic cancer.

DNA Mutational and Copy Number Variation Profiling of Primary Craniofacial Osteosarcomas by Next-Generation Sequencing.

BACKGROUND: Craniofacial osteosarcomas (CFOS) are uncommon malignant neoplasms of the head and neck with different clinical presentation, biological behavior and prognosis from conventional osteosarcomas of long bones. Very limited genetic data have been published on CFOS. METHODS: In the current study, we performed comprehensive genomic studies in 15 cases of high-grade CFOS by SNP array and targeted next generation sequencing. RESULT: Our study shows high-grade CFOS demonstrate highly complex and heterogenous genomic alterations and harbor frequently mutated tumor suppressor genes TP53, CDKN2A/B, and PTEN, similar to conventional osteosarcomas. Potentially actionable gene amplifications involving CCNE1, AKT2, MET, NTRK1, PDGFRA, KDR, KIT, MAP3K14, FGFR1, and AURKA were seen in 43% of cases. GNAS hotspot activating mutations were also identified in a subset of CFOS cases, with one case representing malignant transformation from fibrous dysplasia, suggesting a role for GNAS mutation in the development of CFOS. CONCLUSION: High-grade CFOS demonstrate highly complex and heterogenous genomic alterations, with amplification involving receptor tyrosine kinase genes, and frequent mutations involving tumor suppressor genes.

Unmet needs in people with high-grade glioma: defining criteria for stepped care intervention.

BACKGROUND: We aimed to define levels of unmet supportive care needs in people with primary brain tumor and to reach expert consensus on feasibility of addressing patients' needs in clinical practice. METHODS: We conducted secondary analysis of a prospective cohort study of people diagnosed with high-grade glioma (n = 116) who completed the Supportive Care Needs Survey-Short Form during adjuvant chemoradiation therapy. Participants were allocated to 1 of 3 categories: no need ("no need" for help on all items), low need ("low need" for help on at least 1 item, but no "moderate" or "high" need), or moderate/high need (at least 1 "moderate" or "high" need indicated). Clinical capacity to respond to the proportion of patients needing to be prioritized was assessed. RESULTS: Overall, 13% (n = 5) were categorized as no need, 23% (n = 27) low need, and 64% (n = 74) moderate/high need. At least 1 moderate/high need was reported in the physical and daily living domain (42%) and the psychological (34%) domain. In recognition of health system capacity, the moderate/high need category was modified to distinguish between moderate need ("moderate" need indicated for at least 1 item but "high" need was not selected for any item) and high need (at least 1 "high" need indicated). Results revealed 24% (n = 28) moderate need and 40% (n = 46) high need. Those categorized as high need indicated needing assistance navigating the health system and information. CONCLUSIONS: Using four step allocations resulted in 40% of patients indicating high need. Categories may facilitate appropriate triaging and guide stepped models of healthcare delivery.