本研究旨在比较68Ga-FAPI-04和18F-FDG PET/CT在头颈鳞状细胞癌（HNSCC）的初步分期和复发检测中的表现。77名已被组织学证实或高度疑似患有HNSCC的患者进行了一周的18F-FDG和68Ga-FAPI-04 PET/CT成对检查，其中67名进行了初步分期，10名进行了复查。这两种成像方法的诊断表现进行比较，特别是N分期。评估了配对阳性病灶的SUVmax，SUVmean和目标/背景比（TBR）。此外，探讨了68Ga-FAPI-04 PET/CT对管理的改变以及一些病灶的组织病理学FAP表达。18F-FDG和68Ga-FAPI-04 PET/CT对原发肿瘤（100％）和复发（62.5％）的检测效率相当。在接受颈部淋巴结切除的29名患者中，基于患者（p = 0.031，p = 0.070），颈侧（p = 0.002，p = 0.006）和颈部水平（p <0.001，p <0.001），68Ga-FAPI-04 PET/CT相比18F-FDG更具有评估术前N分期的特异性和准确性。对于远处转移而言，68Ga-FAPI-04 PET/CT检测到的阳性病灶比18F-FDG更多（25 vs 23），SUVmax更高（7.99 ± 9.04 vs 3.62 ± 2.68，p = 0.002）。9例（9/33）颈部淋巴结切除的类型由68Ga-FAPI-04改变。总体而言，10名患者（61名中）的临床管理发生了显着变化。三名患者进行了新辅助治疗后的随访68Ga-FAPI-04 PET/CT：一名患者显示完全缓解，其他两名患者显示进展。68Ga-FAPI-04摄取强度被证实与FAP表达一致。在评估项前，68Ga-FAPI-04在评估HNSCC患者的术前N分期方面优于18F-FDG PET/CT。此外，68Ga-FAPI-04 PET/CT还表现出在临床管理和监测治疗反应方面的潜力。© 2023作者在Springer-Verlag GmbH Germany, part of Springer Nature的独家许可下发表。

This study was designed to compare the performance of 68Ga-FAPI-04 and 18F-FDG PET/CT for initial staging and recurrence detection of head and neck squamous cell carcinoma (HNSCC).Prospectively, 77 patients with histologically proven or highly suspected HNSCC underwent paired 18F-FDG and 68Ga-FAPI-04 PET/CT in a week for either initial staging (n = 67) or restaging (n = 10). The diagnostic performance was compared for the two imaging approaches, especially for N staging. SUVmax, SUVmean, and target-to-background ratio (TBR) were assessed for paired positive lesions. Furthermore, change in management by 68Ga-FAPI-04 PET/CT and histopathologic FAP expression of some lesions were explored.18F-FDG and 68Ga-FAPI-04 PET/CT exhibited a comparable detection efficiency for primary tumor (100%) and recurrence (62.5%). In the twenty-nine patients receiving neck dissection, 68Ga-FAPI-04 PET/CT showed greater specificity and accuracy in evaluating preoperative N staging than 18F-FDG based on patient (p = 0.031 and p = 0.070), neck side (p = 0.002 and p = 0.006), and neck level (p < 0.001 and p < 0.001). As for distant metastasis, 68Ga-FAPI-04 PET/CT detected more positive lesions than 18F-FDG (25 vs 23) and with higher SUVmax (7.99 ± 9.04 vs 3.62 ± 2.68, p = 0.002) by lesion-based analysis. The type of neck dissection in 9 cases (9/33) was altered by 68Ga-FAPI-04. Overall, clinical management was significantly changed in 10 patients (10/61). Three patients had a follow-up 68Ga-FAPI-04 PET/CT post neoadjuvant therapy: One showed complete remission, and the others showed progression. The 68Ga-FAPI-04 uptake intensity was confirmed to be consistent with FAP expression.68Ga-FAPI-04 outperforms 18F-FDG PET/CT in evaluating preoperative N staging in patients with HNSCC. Furthermore, 68Ga-FAPI-04 PET/CT also shows the potential in clinical management and monitoring response to treatment.© 2023. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.