Purpose Selective internal radiation therapy or radioembolization (RE) shows efficacy in unresectable hepatocellular carcinoma (HCC) limited to the liver. This study compared the safety and efficacy of RE and sorafenib in patients with locally advanced HCC. Patients and Methods SIRveNIB (selective internal radiation therapy v sorafenib), an open-label, investigator-initiated, phase III trial, compared yttrium-90 (Y) resin microspheres RE with sorafenib 800 mg/d in patients with locally advanced HCC in a two-tailed study designed for superiority/detriment. Patients were randomly assigned 1:1 and stratified by center and presence of portal vein thrombosis. Primary end point was overall survival (OS). Efficacy analyses were performed in the intention-to-treat population and safety analyses in the treated population. Results A total of 360 patients were randomly assigned (RE, 182; sorafenib, 178) from 11 countries in the Asia-Pacific region. In the RE and sorafenib groups, 28.6% and 9.0%, respectively, failed to receive assigned therapy without significant cross-over to either group. Median OS was 8.8 and 10.0 months with RE and sorafenib, respectively (hazard ratio, 1.1; 95% CI, 0.9 to 1.4; P = .36). A total of 1,468 treatment-emergent adverse events (AEs) were reported (RE, 437; sorafenib, 1,031). Significantly fewer patients in the RE than sorafenib group had grade ≥ 3 AEs (36 of 130 [27.7%]) v 82 of 162 [50.6%]; P < .001). The most common grade ≥ 3 AEs were ascites (five of 130 [3.8%] v four of 162 [2.5%] patients), abdominal pain (three [2.3%] v two [1.2%] patients), anemia (zero v four [2.5%] patients), and radiation hepatitis (two [1.5%] v zero [0%] patients). Fewer patients in the RE group (27 of 130 [20.8%]) than in the sorafenib group (57 of 162 [35.2%]) had serious AEs. Conclusion In patients with locally advanced HCC, OS did not differ significantly between RE and sorafenib. The improved toxicity profile of RE may inform treatment choice in selected patients.

68 Ga-conjugated fibroblast activation protein inhibitor ( 68 Ga-FAPI) has become an attractive agent for positron emission tomography (PET). This study aimed to compare 68 Ga-FAPI-46 PET/computed tomography (CT) with 18 F-fluorodeoxy-D-glucose ( 18 F-FDG) PET/CT for detecting primary cancer and metastatic lesions in patients with head and neck squamous cell carcinoma (HNSCC).Methods: Twelve patients and twenty-eight patients with HNSCC underwent 68 Ga-FAPI-46 and 18 F-FDG PET/CT for initial staging and recurrence detection, respectively. Concordance and diagnostic accuracy of both tracers were analyzed. Semiquantitative parameters, including the maximum and mean of standardized uptake value (SUVmax and SUVmean) and tumor-tobackground ratio (T/B) were compared. FAP expression tumor volume (FTV) and total lesion FAP expression (TLF) of 68 Ga-FAPI-46 were compared with metabolic tumor volume (MTV) and total lesion glycolysis (TLG) of 18 F-FDG, respectively. Differences between semiquantitative parameters were analyzed using paired t-tests.Results: 68 Ga-FAPI -46 PET/CT was 83.3% and 96.4% concordant with 18 F-FDG PET/CT for initial staging and recurrence detection, respectively. Eighteen lesions had histopathological validation and both tracers displayed 100% sensitivity, 50% specificity, and 94.4% accuracy for lesion-based analysis. FTV was greater than MTV (P < 0.05), but no significant differences were observed for the other parameters. Conclusion:68 Ga-FAPI-46 PET/CT showed good concordance and comparable diagnostic performance compared with 18 F-FDG PET/CT for initial staging and recurrence detection in patients with HNSCC.

No abstract

Purpose To compare quantitative parameters and tumour detection rates of [ 68 Ga]Ga-FAPI PET/CT with those of dedicated liver PET/MRI and 18 F-FDG PET in patients with liver malignancies. Procedures Twenty-seven patients (29 imaging studies) with diagnosed or suspected liver malignancies who underwent [ 68 Ga]Ga-FAPI-46 PET/CT, liver PET/MRI, and [ 18 F]FDG PET/CT between September 2020 and June 2021 were retrospectively analysed. MRI findings were used as the reference standard for diagnosis. Results The 27 patients had a median age of 68 years (interquartile range: 60–74 years; 21 men). Primary intrahepatic tumours were reported in 13 patients (15 imaging studies) with cholangiocarcinoma (CCA) and in 14 patients with hepatocellular carcinoma (HCC). All intrahepatic lesions detectable on MRI were also detected on [ 68 Ga]Ga-FAPI-46 PET/CT giving a sensitivity of 100% (19/19), whereas the sensitivity of [ 18 F]FDG PET/CT was 58% (11/19). All intrahepatic lesions were detected on [ 68 Ga]Ga-FAPI-46 PET/CT, on which they showed higher activity (median SUVmax: 15.61 vs. 5.17; P < .001) and higher target-to-background ratio (TBR; median, 15.90 vs. 1.69, P < .001) than on [ 18 F]FDG, especially in patients with CCA (median TBR, 21.08 vs. 1.47, respectively; P < .001). The uptake positivity rate in regional node metastasis was 100% (12/12) on [ 68 Ga]Ga-FAPI-46 PET/CT compared with 58% (7/12) on [ 18 F]FDG PET/CT. All patients with distant metastasis (100%, 14/14) were detected on both [ 18 F]FDG and [ 68 Ga]Ga-FAPI-46 PET/CT imaging, although more distant metastatic lesions were detected on [ 68 Ga]Ga-FAPI-46 PET/CT than on [ 18 F]FDG (96% (42/44) vs. 89% (39/44), respectively). Conclusion [ 68 Ga]Ga-FAPI PET/CT with dedicated liver PET/MRI shows potential for superior detection of hepatic malignancy compared with [ 18 F]FDG PET/CT or MRI alone. Supplementary Information The online version contains supplementary material available at 10.1007/s11307-022-01732-2.

Purpose This study aimed to investigate functional abnormalities in the brain of patients with neurological adverse effects following COVID-19 (coronavirus disease 2019) vaccination using 18 F-FDG PET/MRI and 15 O-water PET. Methods Eight patients (1 man and 7 women, aged 26–47 years [median age, 36.5 years]) who experienced neurological symptoms after the first COVID-19 vaccination underwent CT, MRI, 18 F-FDG PET/MRI, and 15 O-water PET of the brain. After 7 days, each patient underwent a follow-up 18 F-FDG PET/MRI and 15 O-water PET of the brain. Imaging data were analyzed using visual and semiquantitative analyses, which included a cluster subtraction workflow ( P = 0.05). Results There was no evidence of vascular abnormalities, acute infarction, or hemorrhage on the CT or MRI scans. On the 15 O-water PET images, 1 patient had mildly significant decreases in perfusion in the bilateral thalamus and bilateral cerebellum, and another patient showed a diffuse increase in perfusion in the cerebral white matter. The visual and semiquantitative analyses showed hypometabolism in the bilateral parietal lobes in all 8 patients on both the first and follow-up 18 F-FDG PET/MRI scans. Metabolic changes in the bilateral cuneus were also observed during the first visit; all patients exhibited neurological symptoms. Moreover, 6 patients showed hypometabolism, and 2 patients showed hypermetabolism. Conclusion All regions of metabolic abnormality were part of the fear network model that has been implicated in anxiety. Our study findings support the concepts of and provide evidence for the immunization stress-related response and the biopsychosocial model.