（18）F-VM4-037 正电子发射断层扫描/计算机断层扫描成像在肾细胞癌中的应用：一项 II 期先导研究。
PET/CT imaging of renal cell carcinoma with (18)F-VM4-037: a phase II pilot study.
机构信息
Molecular Imaging Program, National Cancer Institute, Bethesda, MD, USA.
Frederick National Laboratory for Cancer Research, Clinical Research Directorate/CMRP, Leidos Biomedical Research Inc., Frederick, MD, 21702, USA.
出版信息
Abdom Radiol (NY). 2016 Jan;41(1):109-18. doi: 10.1007/s00261-015-0599-1.
BACKGROUND
Carbonic anhydrase IX (CA-IX) is a potential imaging biomarker of clear cell renal cell carcinoma (ccRCC). Here, we report the results of a phase II clinical trial of a small molecule radiotracer targeting CA-IX ((18)F-VM4-037) in ccRCC.
METHODS
Between October 2012 and May 2013, 11 patients with kidney masses underwent (18)F-VM4-037 PET/CT prior to surgery. Dynamic imaging was performed for the first 45 min post injection and whole-body imaging was obtained at 60 min post injection. Tumors were surgically excised or biopsied within 4 weeks of imaging.
RESULTS
All patients tolerated the radiotracer well with no adverse events. Ten of the 11 patients had histologically confirmed malignancy. One patient had a Bosniak Type 3 cyst with no tumor found at surgery. Two patients had extrarenal disease and 9 had tumors only in the kidney. Primary ccRCC lesions were difficult to visualize on PET alone due to high uptake of the tracer in the adjacent normal kidney parenchyma, however when viewed in conjunction with CT, the tumors were easily localized. Metastatic lesions were clearly visible on PET. Mean SUV for primary kidney lesions was 2.55 in all patients; in patients with histologically confirmed ccRCC, the mean SUV was 3.16. The time-activity curves (TAC) are consistent with reversible ligand binding with peak activity concentration at 8 min post injection followed by washout. Distribution Volume Ratio (DVR) of the lesions was measured using the Logan graphical analysis method. The mean DVR value across the 9 kidney lesions was 5.2 ± 2.8, (range 0.68-10.34).
CONCLUSION
18F-VM4-037 is a well-tolerated PET agent that allows same day imaging of CA-IX expression. The agent demonstrated moderate signal uptake in primary tumors and excellent visualization of CA-IX positive metastases. While the evaluation of primary ccRCC lesions is challenging due to high background activity in the normal kidney parenchyma, 18F-VM4-037 may be most useful in the evaluation of metastatic ccRCC lesions.
背景
碳酸酐酶 IX（CA-IX）是肾透明细胞癌（ccRCC）的潜在成像生物标志物。在这里，我们报告了一种针对 CA-IX 的小分子放射性示踪剂（18F-VM4-037）在 ccRCC 中的 II 期临床试验结果。
方法
在 2012 年 10 月至 2013 年 5 月期间，11 名患有肾肿块的患者在手术前进行了（18）F-VM4-037 PET/CT。注射后前 45 分钟进行动态成像，注射后 60 分钟进行全身成像。肿瘤在成像后 4 周内进行手术切除或活检。
结果
所有患者均耐受放射性示踪剂，无不良反应。11 名患者中有 10 名经组织学证实为恶性肿瘤。1 名患者为 Bosniak 3 型囊肿，手术时未发现肿瘤。2 名患者有肾外疾病，9 名患者仅在肾脏有肿瘤。由于相邻正常肾实质中示踪剂摄取量高，单独 PET 难以观察到原发性 ccRCC 病变，但与 CT 结合时，肿瘤很容易定位。转移病变在 PET 上清晰可见。所有患者的原发性肾脏病变的平均 SUV 为 2.55；在经组织学证实为 ccRCC 的患者中，平均 SUV 为 3.16。时间-活性曲线（TAC）与可逆配体结合一致，注射后 8 分钟达到峰值活性浓度，随后洗脱。使用 Logan 图形分析方法测量病变的分布容积比（DVR）。9 个肾脏病变的平均 DVR 值为 5.2±2.8（范围 0.68-10.34）。
结论
18F-VM4-037 是一种耐受性良好的 PET 试剂，可实现 CA-IX 表达的同日成像。该试剂在原发性肿瘤中表现出中等信号摄取，并能很好地显示 CA-IX 阳性转移灶。虽然由于正常肾实质中的背景活性高，原发性 ccRCC 病变的评估具有挑战性，但 18F-VM4-037 可能在评估转移性 ccRCC 病变方面最有用。
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