BackgroundCerebral palsy (CP) results from a static brain lesion during pregnancy or early life and remains the most common cause of physical disability in children (1 in 500). While the brain lesion is static, the physical manifestations and medical issues may progress resulting in altered motor patterns. To date, there are no prospective longitudinal studies of CP that follow a birth cohort to track early gross and fine motor development and use Magnetic Resonance Imaging (MRI) to determine the anatomical pattern and likely timing of the brain lesion. Existing studies do not consider treatment costs and outcomes. This study aims to determine the pathway(s) to motor outcome from diagnosis at 18 months corrected age (c.a.) to outcome at 5 years in relation to the nature of the brain lesion (using structural MRI).MethodsThis prospective cohort study aims to recruit a total of 240 children diagnosed with CP born in Victoria (birth years 2004 and 2005) and Queensland (birth years 2006–2009). Children can enter the study at any time between 18 months to 5 years of age and will be assessed at 18, 24, 30, 36, 48 and 60 months c.a. Outcomes include gross motor function (GMFM-66 & GMFM-88), Gross Motor Function Classification System (GMFCS); musculoskeletal development (hip displacement, spasticity, muscle contracture), upper limb function (Manual Ability Classification System), communication difficulties using Communication and Symbolic Behaviour Scales-Developmental Profile (CSBS-DP), participation using the Paediatric Evaluation of Disability Inventory (PEDI), parent reported quality of life and classification of medical and allied health resource use and determination of the aetiology of CP using clinical evaluation combined with MRI. The relationship between the pathways to motor outcome and the nature of the brain lesion will be analysed using multiple methods including non-linear modelling, multilevel mixed-effects models and generalised estimating equations.DiscussionThis protocol describes a large population-based study of early motor development and brain structure in a representative sample of preschool aged children with CP, using direct clinical assessment. The results of this study will be published in peer reviewed journals and presented at relevant international conferences.Trial registrationAustralia and New Zealand Clinical Trials Register (ACTRN1261200169820)
This large prospective intraindividual comparison of [ 18 F]PSMA-1007 PET/CT vs [ 68 Ga]Ga-PSMA-11 PET/CT has demonstrated overall high concordance (92%) for TNM stage in the context of prostate cancer primary staging, biochemical recurrence and evaluation of patients with metastatic disease. Reduced [ 18 F]PSMA-1007 urinary radiotracer excretion improves characterisation of disease adjacent the bladder (prostate or prostate bed following de nitive treatment, including local invasion) and ureters (peri-ureteric nodes) compared to [ 68 Ga]Ga-PSMA-11. [ 18 F]PSMA-1007 demonstrates signi cantly higher uptake within involved nodes and bone metastases, and physiologic tissues including liver, spleen, neural ganglia, bone marrow and benign nodes. Inexperienced reporters of [ 18 F]PSMA-1007 PET should understand that hepatic uptake may obscure metastases within the liver or adjacent adrenal gland, and that [ 18 F]PSMA-1007 is associated with more equivocal bone lesions. Both tracers are acceptable for imaging of prostate cancer, with factors in uencing choice including availability (local generator production of [ 68 Ga]Ga-PSMA-11 vs external cyclotron supply [ 18 F]PSMA-1007), preference for improved characterisation of disease in the prostate and pelvic nodes (favouring [ 18 F]PSMA-1007) versus likelihood of visceral metastasis (favouring [ 68 Ga]Ga-PSMA-11) and the experience of reporting specialists to exclude benign patterns of uptake, particularly neural ganglia and equivocal bone lesions.
Purpose: [ 18 F]PSMA-1007 offers advantages of low urinary tracer excretion and improved resolution for imaging prostate cancer. However, non-speci c bone lesions (NSBLs), de ned as mild to moderate focal bone uptake without a typical morphological correlate on CT, are a common nding on [ 18 F]PSMA-1007 PET/CT. The purpose of this study was to investigate the clinical outcomes of patients with [ 18 F]PSMA-1007 avid NSBLs, to determine whether patients with NSBLs represent a higher risk clinical cohort, and to determine whether SUVmax can be used as a classi er of bone metastasis.Methods: A retrospective audit of 214 men with prostate cancer was performed to investigate the clinical outcomes of [ 18 F]PSMA-1007 avid NSBLs according to de ned criteria. We also compared the serum PSA, Gleason score and uptake time of patients with [ 18 F]PSMA-1007 avid NSBLs to patients without [ 18 F]PSMA-1007 avid bone lesions. Finally, we assessed whether SUVmax is a good classi er of bone metastases using ROC curve analysis.Results: No [ 18 F]PSMA-1007 avid NSBLs met criteria for a likely malignant or de nitely malignant lesion after a median 15.8-month follow-up interval (11.9% de nitely benign, 50.3% likely benign, and 37.7% equivocal). There were no statistically signi cant differences in serum PSA, Gleason score and uptake time between patients with [ 18 F]PSMA-1007 avid NSBLs and those without [ 18 F]PSMA-1007 avid bone lesions. All NSBLs with adequate follow-up had SUVmax ≤11.1. When comparing NSBLs to de nite prostate cancer bone metastases, the highest SUVmax value recorded was a good classi er of bone metastasis, and an SUVmax cut-point of ≥7.2 maximised the Youden's index.Conclusion: [ 18 F]PSMA-1007 avid NSBLs rarely represent prostate cancer bone metastases. When identi ed in the absence of de nite metastatic disease elsewhere, it is appropriate to classify those with SUVmax <7.2 as likely benign. NSBLs with SUVmax 7.2-11.1 may be classi ed as equivocal or metastatic, with patient clinical risk factors, scan appearance, and potential management implications used to guide interpretation.
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