Image-Guided Surgery in Patients with Pancreatic Cancer: First Results of a Clinical Trial Using SGM-101, a Novel Carcinoembryonic Antigen-Targeting, Near-Infrared Fluorescent Agent.
Image-Guided Surgery in Patients with Pancreatic Cancer: First Results of a Clinical Trial Using SGM-101, a Novel Carcinoembryonic Antigen-Targeting, Near-Infrared Fluorescent Agent.
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DOI：
10.1245/s10434-018-6655-7
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发表时间：
2018-10
影响因子：
3.7
通讯作者：
Vahrmeijer AL
中科院分区：
文献类型：
--
作者：
Hoogstins CES;Boogerd LSF;Sibinga Mulder BG;Mieog JSD;Swijnenburg RJ;van de Velde CJH;Farina Sarasqueta A;Bonsing BA;Framery B;Pèlegrin A;Gutowski M;Cailler F;Burggraaf J;Vahrmeijer AL
近红外(NIR)荧光是一种很有前途的新的成像技术，可以帮助术中界定胰腺癌(PDAC)，从而提高根治性切除率。本研究对一种新型的荧光标记抗癌胚抗原抗体SGM-101进行了研究。第1阶段研究旨在评估术中使用SGM-101的荧光肿瘤成像在接受PDAC手术探查的患者中的耐受性和可行性。在接受PDAC手术前至少48小时，12名患者被静脉注射5，7.5或10毫克的SGM-101。服药后定期进行耐受性评估。使用Quest近红外成像系统对手术野进行成像。研究荧光与肿瘤在组织病理学上的一致性。在这项研究中，SGM-101特异性地聚集在表达CEA的原发肿瘤以及腹膜和肝转移瘤中，使得术中实时荧光成像成为可能。原发肿瘤的平均肿瘤背景比(TBR)为1.6，转移性肿瘤为1.7。发现1例假阳性病变(表达CEA的导管内乳头状黏液性肿瘤)。假阴性两次被认为是覆盖在血液或组织上的阻止荧光信号的结果。使用荧光标记的抗CEA抗体在术中检测原发PDAC和转移瘤是安全和可行的。这些结果值得进一步研究，以确定这项技术对临床决策和总存活率的影响。
Near-infrared (NIR) fluorescence is a promising novel imaging technique that can aid in intraoperative demarcation of pancreatic cancer (PDAC) and thus increase radical resection rates. This study investigated SGM-101, a novel, fluorescent-labeled anti-carcinoembryonic antigen (CEA) antibody. The phase 1 study aimed to assess the tolerability and feasibility of intraoperative fluorescence tumor imaging using SGM-101 in patients undergoing a surgical exploration for PDAC. At least 48 h before undergoing surgery for PDAC, 12 patients were injected intravenously with 5, 7.5, or 10 mg of SGM-101. Tolerability assessments were performed at regular intervals after dosing. The surgical field was imaged using the Quest NIR imaging system. Concordance between fluorescence and tumor presence on histopathology was studied. In this study, SGM-101 specifically accumulated in CEA-expressing primary tumors and peritoneal and liver metastases, allowing real-time intraoperative fluorescence imaging. The mean tumor-to-background ratio (TBR) was 1.6 for primary tumors and 1.7 for metastatic lesions. One false-positive lesion was detected (CEA-expressing intraductal papillary mucinous neoplasm). False-negativity was seen twice as a consequence of overlying blood or tissue that blocked the fluorescent signal. The use of a fluorescent-labeled anti-CEA antibody was safe and feasible for the intraoperative detection of both primary PDAC and metastases. These results warrant further research to determine the impact of this technique on clinical decision making and overall survival.
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影响因子：
4.7
作者：
Boonstra MC;Prakash J;Van De Velde CJ;Mesker WE;Kuppen PJ;Vahrmeijer AL;Sier CF
通讯作者：
Sier CF
影响因子：
3.2
作者：
Kaushal, Sharmeela;McElroy, Michele K.;Luiken, George A.;Talamini, Mark A.;Moossa, A. R.;Hoffman, Robert M.;Bouvet, Michael
通讯作者：
Bouvet, Michael
影响因子：
3.7
作者：
Merkow, Ryan P.;Bilimoria, Karl Y.;Pawlik, Timothy M.
通讯作者：
Pawlik, Timothy M.
影响因子：
45.3
作者：
Frangioni, John V.
通讯作者：
Frangioni, John V.
影响因子：
1.6
作者：
Hutteman, M.;van der Vorst, J. R.;Vahrmeijer, A. L.
通讯作者：
Vahrmeijer, A. L.