Department of Radiology, Memorial Sloan Kettering Cancer Center, New York, New York.
Department of Radiology, Weill Cornell Medical College, New York, New York.
Clin Cancer Res. 2020 Jul 1;26(13):3110-3116. doi: 10.1158/1078-0432.CCR-19-3484. Epub 2020 Apr 3.
We performed a first-in-human clinical trial. The aim of this study was to determine safety and feasibility of PET imaging with F-PARPi in patients with head and neck cancer.
Eleven patients with newly diagnosed or recurrent oral and oropharyngeal cancer were injected with F-PARPi (331 ± 42 MBq), and dynamic PET/CT imaging was performed between 0 and 25 minutes postinjection. Static PET/CT scans were obtained at 30, 60, and 120 minutes postinjection. Blood samples for tracer concentration and metabolite analysis were collected. Blood pressure, ECG, oxygen levels, clinical chemistry, and complete blood count were obtained before and after tracer administration.
F-PARPi was well-tolerated by all patients without any safety concerns. Of the 11 patients included in the analysis, F-PARPi had focal uptake in all primary lesions ( = 10, SUV = 2.8 ± 1.2) and all F-FDG-positive lymph nodes ( = 34). F-PARPi uptake was seen in F-FDG-negative lymph nodes of 3 patients ( = 6). Focal uptake of tracer in primary and metastatic lesions was corroborated by CT alone or in combination with F-FDG. The overall effective dose with F-PARPi PET was 3.9 mSv - 5.2 mSv, contrast was high [SUV(lesion)/SUV(trapezius muscle) = 4.5] and less variable than F-FDG when compared with the genioglossus muscle (1.3 vs. 6.0, = 0.001).
Imaging of head and neck cancer with F-PARPi is feasible and safe. F-PARPi detects primary and metastatic lesions, and retention in tumors is longer than in healthy tissues.
我们进行了首次人体临床试验。本研究旨在确定头颈癌患者使用 F-PARPi 进行 PET 成像的安全性和可行性。
11 名新诊断或复发性口腔和口咽癌患者注射了 F-PARPi（331 ± 42MBq），在注射后 0 至 25 分钟进行动态 PET/CT 成像。在注射后 30、60 和 120 分钟进行静态 PET/CT 扫描。采集示踪剂浓度和代谢物分析的血样。在给予示踪剂前后获取血压、心电图、氧水平、临床化学和全血细胞计数。
所有患者均耐受良好，未出现任何安全性问题。在纳入分析的 11 名患者中，F-PARPi 在所有原发性病变（= 10，SUV = 2.8 ± 1.2）和所有 F-FDG 阳性淋巴结（= 34）中均有局灶性摄取。3 名患者（= 6）的 F-FDG 阴性淋巴结中可见 F-PARPi 摄取。单独或结合 F-FDG，CT 可证实原发性和转移性病变中示踪剂的局灶性摄取。使用 F-PARPi PET 的总有效剂量为 3.9 mSv-5.2 mSv，与 genioglossus 肌肉相比，对比度高（SUV（病变）/SUV（斜方肌）= 4.5）且变异性较小（1.3 比 6.0，= 0.001）。
F-PARPi 对头颈癌的成像既可行又安全。F-PARPi 可检测原发性和转移性病变，并且在肿瘤中的滞留时间长于健康组织。
