ABSTRACT
ABSTRACT Objectives: Accurate preoperative prediction of adverse pathology is crucial for treatment planning of renal cell carcinoma (RCC). Previous studies have emphasized the potential of prostate-specific membrane antigen positron emission tomography / computed tomography (PSMA PET/CT) in differentiating between benign and malignant localized renal tumors. However, there is a scarcity of case reports elucidating the identification of aggressive pathological features using PET/CT. Our study was designed to prospectively compare the diagnostic value of enhanced CT, 68Ga-PSMA-11 and 18F-fluorodeoxyglucose (18F-FDG) PET/CT in clear-cell renal cell carcinoma (ccRCC) with necrosis or sarcomatoid or rhabdoid differentiation. Materials and Methods: A prospective case series of patients with a newly diagnosed renal mass who underwent enhanced CT, 68Ga-PSMA-11 and 18F-FDG PET/CT within 30 days prior to nephrectomy was included. Complete preoperative and postoperative clinicopathological data were recorded. Patients who received neoadjuvant targeted therapy, declined enhanced CT or PET/CT scanning, refused surgical treatment or had non-ccRCC pathological indications were excluded. Radiological parameters were compared within subgroups of pathological characteristics. Bonferroni corrections were used to adjust for multiple testing and statistical significance was set at a p-value less than 0.017. Results: Seventy-two patients were available for the final analysis. Enhanced CT demonstrated poor performance in identifying necrosis, sarcomatoid or rhabdoid differentiation and adverse pathology (all P > 0.05). The maximum standardized uptake value (SUVmax) of 68Ga-PSMA-11 PET/CT was more effective than 18F-FDG PET/CT in identifying tumor necrosis and adverse pathology, with an area under the curve (AUC) of 0.85 (cutoff value=25.26, p<0.001; Delong test z=2.709, p=0.007) for tumor necrosis and AUC of 0.90 (cutoff value=25.26, p<0.001; Delong test z=3.433, p<0.001) for adverse pathology. However, no significant statistical difference was found between 68Ga-PSMA-11 and 18F-FDG PET/CT in predicting sarcomatoid or rhabdoid feature (AUC of 0.91 vs.0.75, Delong test z=1.998, p=0.046). Subgroup analyses based on age, sex, tumor location, maximal diameter, stage and WHO/ISUP grade demonstrated that 68Ga-PSMA-11 PET/CT SUVmax had a significant predictive value for adverse pathology. Enhanced CT value and SUVmax demonstrated strong reliability [intraclass correlation coefficient (ICC) > 0.80], indicating a robust correlation. Conclusions: 68Ga-PSMA-11 PET/CT demonstrates distinct advantages in identifying aggressive pathological features of primary ccRCC when compared to enhanced CT and 18F-FDG PET/CT. Further research and assessment are warranted to fully establish the clinical utility of 68Ga-PSMA-11 PET/CT in ccRCC.
ABSTRACT
Introdução: este estudo trata do controle de qualidade do radiofármaco utilizado em estudos de PET-CT para diagnóstico e/ou estadiamento de pacientes acometidos pelo câncer de próstata. Objetivo: avaliar a qualidade do radiofármaco PSMA-11, marcado com uso de gerador de Ge68-Ga68 itinerante. Metodologia: análise do aspecto visual, pH e pureza radioquímica do radiofármaco marcado a cada recebimento do gerador de Ge68-Ga68. Resultado: todas as marcações realizadas se apresentaram límpidas quanto ao aspecto visual, o pH ficou entre 5,0 e 6,0 e a pureza radioquímica apresentou em 92% dos casos valores ≥ 96%. Conclusão: com os devidos controles de qualidade, pode ser uma opção para uso na clínica médica, em serviços que não disponham de condição para adquirir um sistema, por ser importado.
Introduction: this study works with the quality control of the radiopharmaceutical used in PET-CT studies for diagnosis and / or staging of patients affected with prostate cancer. Objective: evaluate the quality of the PSMA-11 marked radiopharmaceutical using a Ge68-Ga68 itinerant generator. Methodology: analysis of the visual aspect, pH and radiochemical purity of the marked radiopharmaceutical on each receiving of the Ge68-Ga68 generator. Results: all performed markings were clear in terms of visual appearance, pH was between 5.0 and 6.0 and radiochemical purity was 92% with value ≥ 96%. Conclusion: with proper quality controls it can be an option for application in the medical clinic, services centers unable to purchase a system due to importation process.