Lymphoseek 在乳腺癌和黑色素瘤淋巴结术中定位中的试验
Lymphoseek® 和 Vital Blue Dye 作为淋巴组织靶向剂在接受淋巴结定位的已知黑色素瘤或乳腺癌患者中进行的第 3 期、前瞻性、开放标签、多中心比较研究
研究概览
详细说明
在患有原发性黑色素瘤和乳腺癌的患者中,淋巴结状态通常是预后的有力预测指标,并影响患者在手术后可能遵循的治疗过程。 为了降低淋巴结转移的发病率和检测成本,外科肿瘤学家开发了一种方法,可以在术中识别并切除前哨淋巴结(引流盆中的第一个淋巴结)。 这种称为前哨淋巴结活检的技术对黑色素瘤转移和乳腺癌转移具有极高的阴性预测值。 Morton 等人 (2005) 和 Rossi 等人 (2006) 的两项最大的黑色素瘤试验报告的假阴性率分别为 6.3% 和 14.7%。 Morton 等人 (2006) 在可能是迄今为止报道的最成熟的试验中显示了 3.4% 的假阴性率。 越来越多的证据表明前哨淋巴结活检将对黑色素瘤的治疗产生重大影响。 前哨淋巴结活检对乳腺癌转移也有极高的阴性预测值;假阴性率在 0% 到 9% 之间。 越来越多的证据表明前哨淋巴结活检将对乳腺癌的治疗产生重大影响。 虽然生存和局部复发研究尚未完成,但该技术已成为普遍做法。
使用放射性药物进行淋巴标测是一种核医学检查,可为外科医生确定第一个接受来自原发肿瘤部位淋巴液流动的淋巴结。 移除该节点并分析是否存在恶性细胞。 通过在手术前定位淋巴结,可以使用小切口移除淋巴结并进行更小的解剖。 该技术的高阴性预测值似乎提供了准确的分期程序,并且可以使淋巴结阴性的患者免于完全淋巴结清扫的发病率。 因此,通过淋巴结标测和活检对黑色素瘤进行分期可能等同于区域淋巴结清扫术,而没有随之而来的术后并发症。
理想的淋巴结显像剂应表现出从注射部位快速清除、在第一个引流淋巴结内快速摄取和高滞留,以及其余淋巴结的低摄取。 理想的药剂还应具有低辐射吸收;生物安全性高;方便、快速、稳定的锝99m标记;和生化纯度。
Lymphoseek(锝-99m 标记的二亚乙基三胺五乙酸-甘露糖基-葡聚糖,[Tc-99m]DTPA-甘露糖基-葡聚糖)是一种放射性示踪剂,通过与位于树突细胞表面的甘露糖结合蛋白结合而在淋巴组织中积累和巨噬细胞。 Lymphoseek 是一种大分子,由多个 DTPA 和甘露糖单元组成,每个单元都合成连接到一个 10 道尔顿的葡聚糖主链上。 甘露糖充当受体的底物,DTPA 充当螯合剂,用于标记 Tc-99m。
研究类型
注册 (实际的)
阶段
- 第三阶段
联系人和位置
学习地点
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Tel Aviv、以色列、64239
- Schlomo Schneebaum, M.D.
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Alabama
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Alexander City、Alabama、美国、35010
- Barbara Michna, M.D
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Birmingham、Alabama、美国、35294
- Helen Krontiras, M.D.
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California
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La Jolla、California、美国、92093
- Anne Wallace, M.D.
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Laguna Hills、California、美国、92653
- Ken Deck, M.D.
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Sacramento、California、美国、95817
- Steve Martinez, M.D.
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Santa Monica、California、美国、90404
- Mark Faries, M.D.
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Florida
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Miami、Florida、美国、33101
- Eli Avisar, M.D.
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Tampa、Florida、美国、33612
- Charles Cox, M.D.
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Tampa、Florida、美国、33612
- Vernon Sondak, M.D.
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Ohio
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Cleveland、Ohio、美国、44106
- Julian Kim, M.D.
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Cleveland、Ohio、美国、44109
- Bruce Averbook, M.D
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Columbus、Ohio、美国、43210
- Stephen Povoski, M.D.
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Pennsylvania
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Bryn Mawr、Pennsylvania、美国、19010
- Thomas Frazier, M.D.
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Philadelphia、Pennsylvania、美国、19096
- Ned Carp, M.D.
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
纳入标准:
- 患者在参与研究之前已提供 HIPAA 授权的书面知情同意书,如适用,他/她的负责护理人员也已提供。
- 患者是手术干预的候选人,淋巴结定位是手术计划的一部分。
- 患者在同意时至少年满 18 岁。
- 患者的 ECOG 体能状态为 0 - 2 级 [8]。
- 患者在进入研究时具有临床阴性淋巴结状态。
- 如果有生育能力,患者在使用 Lymphoseek 前 72 小时内妊娠试验呈阴性,已进行手术绝育,或已绝经至少 1 年。
- 该患者目前没有参加另一项药物研究。
黑色素瘤患者
- 患者被诊断为原发性黑色素瘤。
乳腺癌患者
- 患者被诊断为原发性乳腺癌。
- 如果淋巴结活检是手术计划的一部分,则患有纯导管原位癌 (DCIS) 或非浸润性癌的患者。
排除标准:
- 患者怀孕或哺乳;
- 患者有转移癌的临床或放射学证据,包括明显异常或肿大的淋巴结(即,所有患者都应为任何 T、N0、M0);
- 患者已知对 Lymphazurin 或 Patent Bleu V 过敏。
黑色素瘤患者
- 患者的 Breslow 深度小于 0.75mm 的肿瘤。
- 术前接受过化疗、免疫治疗或放疗的患者;
- 被诊断患有先前浸润性黑色素瘤的患者,该黑色素瘤可能发生在同一身体区域或可能引流至同一淋巴结盆地,或患有躯干或四肢原发性黑色素瘤且先前患有乳腺癌可能引流至同一腋窝淋巴结盆地的患者;
- 接受过任何类型的淋巴结盆手术或对可能引流原发性黑色素瘤的淋巴结盆进行过放射治疗的患者;
- 因原发性黑色素瘤(>1 cm)或复杂重建(旋转、游离皮瓣或任何类型的皮肤移植)而接受广泛切除的患者。
乳腺癌患者
- 患者患有双侧原发性乳腺癌或乳房内有多个肿瘤;
- 曾接受过乳房植入物、乳房缩小成形术或腋窝手术等外科手术的患者;
- 因任何原因计划进行双侧乳房切除术的患者;
- 对受影响的乳房或腋窝进行过术前放射治疗的患者
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:Lymphoseek,淋巴标测,注射
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乳腺癌:Lymphoseek 的皮内给药:注射 0.2-0.4
mL 多次分次注射或单次注射覆盖完整的原发肿瘤或切除活检部位或 Lymphoseek 乳晕周围给药:在乳晕边缘分多次分次注射 0.2-.04 mL Lymphoseek 或乳晕下给药:注射 0.2-0.4在乳晕下区域进行多次分次注射或单次注射,作为皮下注射或瘤周给药 Lymphoseek:分多次分次注射 2.0-4.0 mL,在肿瘤或活检腔周围进行实质内注射。
对于黑色素瘤患者皮内注射 Lymphoseek:注射 0.2-0.4
mL 多次分次注射或单次注射覆盖完整的原发肿瘤或切除活检部位。
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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蓝色染料和 Lymphoseek 的索引
大体时间:注射 Lymphoseek 和蓝色染料后的手术
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术中通过蓝色染料检测到的淋巴结比例也通过 Lymphoseek 检测到。
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注射 Lymphoseek 和蓝色染料后的手术
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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蓝色染料和 Lymphoseek 的反向索引
大体时间:注射 Lymphoseek 和蓝色染料后的手术
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术中通过 Lymphoseek 检测到的淋巴结比例也通过蓝色染料检测到。
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注射 Lymphoseek 和蓝色染料后的手术
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合作者和调查者
调查人员
- 研究主任:Richard Orahood, M.D.、Navidea Biopharmaceuticals
出版物和有用的链接
一般刊物
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研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
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