新功能、新界面、新体验,扫描即可下载生物谷APP!
首页 » BIOON报道 » Ann Surg Oncol:新的成像剂可以更好的帮助检测癌症

Ann Surg Oncol:新的成像剂可以更好的帮助检测癌症

来源:生物谷 2013-03-22 22:18

2013年3月21日 讯 /生物谷BIOON/ --近日,美国加州大学圣地亚哥医学院的研究人员已经证实由加州大学San Diego Moores癌症中心设计和开发的一种新的成像染料是一种检测和映射已经转移到达淋巴结癌症的有效试剂。

放射性染料叫Tilmanocept,能成功地确定癌变的淋巴结,比现行标准染料更好地标记癌症。 III期临床试验的结果在线发表在Annals of Surgical Oncology杂志上。

发明者David R. Vera博士说:Tilmanocept是一种专门检测淋巴结的新型放射性试剂。加州大学圣地亚哥分校医学院所开发的这一试剂为外科医生提供了新的工具,以准确检测黑色素瘤和乳腺癌。在2013年3月13日,Tilmanocept获得FDA批准。

癌症诊断后,医生希望可以肯定这种疾病还没有扩散到患者的淋巴结,尤其是前哨淋巴结。
淋巴系统是癌细胞进入血液的一种方式。通过手术去除和检查肿瘤的前哨淋巴结,医生可以更好地判断癌细胞是否已经扩散。

因为淋巴结在转移中起着重要的作用,Tilmanocept是第一个绑定到淋巴结的试剂。Tilmanocept能帮助确定更多的癌症节点,导致患者得到更好的手术后护理,特别是那些有一个以上的阳性前哨淋巴结的患者。

研究人员注射Tilmanocept和标准蓝色染料到肿瘤区域。然后,使用一个手持的放射线检测器,他们发现淋巴结会吸收药物的放射性。研究人员发现,超过99%的前哨淋巴结含有蓝色染料,同时也还含有Tilmanocept。

在这些节点中,18%呈阳性。蓝色染料检测到76%,新的放射性试剂检测到94%的恶性肿瘤。Tilmanocept与目前的技术是一样精确的,并且使用简单,能在较少的时间找到淋巴结,并且从体内清除的速度更快。

第三阶段的研究得到了Navidea生物制药资助。 Lymphoseek的安全性和有效性是建立在涉及332名黑色素瘤或乳腺癌患者的两个临床试验上的。第三阶段临床试验涉及13个医疗中心的148例黑色素瘤伴有乳腺癌发生的患者。在临床试验中发现的最常见的副作用是两例患者在注射部位疼痛或不适。(生物谷:Bioon.com)

Comparative Evaluation of [99mTc]Tilmanocept for Sentinel Lymph Node Mapping in Breast Cancer Patients: Results of Two Phase 3 Trials

Anne M. Wallace MD, Linda K. Han MD, Stephen P. Povoski MD, Kenneth Deck MD, Schlomo Schneebaum MD, Nathan C. Hall MD, PhD, Carl K. Hoh MD, Karl K. Limmer MD, Helen Krontiras MD, Thomas G. Frazier MD, Charles Cox MD, Eli Avisar, Mark Faries MD, Dennis W. King PhD, Lori Christman PhD, David R. Vera PhD

Background
Sentinel lymph node (SLN) surgery is used worldwide for staging breast cancer patients and helps limit axillary lymph node dissection. [99mTc]Tilmanocept is a novel receptor-targeted radiopharmaceutical evaluated in 2 open-label, nonrandomized, within-patient, phase 3 trials designed to assess the lymphatic mapping performance.
Methods
A total of 13 centers contributed 148 patients with breast cancer. Each patient received [99mTc]tilmanocept and vital blue dye (VBD). Lymph nodes identified intraoperatively as radioactive and/or blue stained were excised and histologically examined. The primary endpoint, concordance (lower boundary set point at 90 %), was the proportion of nodes detected by VBD and [99mTc]tilmanocept.
Results
A total of 13 centers contributed 148 patients who were injected with both agents. Intraoperatively, 207 of 209 nodes detected by VBD were also detected by [99mTc]tilmanocept for a concordance rate of 99.04 % (p < 0.0001). [99mTc]tilmanocept detected a total of 320 nodes, of which 207 (64.7 %) were detected by VBD. [99mTc]Tilmanocept detected at least 1 SLN in more patients (146) than did VBD (131, p < 0.0001). In 129 of 131 patients with ≥1 blue node, all blue nodes were radioactive. Of 33 pathology-positive nodes (18.2 % patient pathology rate), [99mTc]tilmanocept detected 31 of 33, whereas VBD detected only 25 of 33 (p = 0.0312). No pathology-positive SLNs were detected exclusively by VBD. No serious adverse events were attributed to [99mTc]tilmanocept.
Conclusion
[99mTc]Tilmanocept demonstrated success in detecting a SLN while meeting the primary endpoint. Interestingly, [99mTc]tilmanocept was additionally noted to identify more SLNs in more patients. This localization represented a higher number of metastatic breast cancer lymph nodes than that of VBD.

温馨提示:87%用户都在生物谷APP上阅读,扫描立刻下载! 天天精彩!


相关标签

最新会议 培训班 期刊库