NCT02857608撤回2 期
A Prospective, Open-Label, Multi-center Comparison of Lymphoseek Identified Lymph Nodes and Clinically Identified Lymph Nodes of Subjects With Known Cancer of the Anus
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Concordance (the proportion of the number of subjects with lymph nodes identified by Lymphoseek and standard of care methods compared to the number of subjects with lymph nodes identified by standard of care methods)
研究概览
简要总结
Prospective, open-label, within-subject, multi-center pilot study of Lymphoseek in the detection of lymph nodes in subjects with known squamous cell carcinoma of the anus.
详细描述
Prospective, open-label, within-subject, multi-center pilot study of Lymphoseek in the detection of lymph nodes in subjects with known squamous cell carcinoma of the anus. All subjects will receive a single dose of 50 µg Lymphoseek radiolabeled with 0.5 millicurie (mCi) (18.5 MBq) 99mTc.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has provided written informed consent with Health Insurance Portability and Accountability Act of 1996 (HIPAA) authorization
- •Has histologically confirmed squamous cell carcinoma of the anus (anal canal or perianus)
- •Has a documented clinical stage using the tumor, lymph node, metastasis staging (TNM) classification system that was established by at least physical exam with manual palpation, digital anorectal examination, high-resolution anoscopy and PET/CT imaging evaluation of the bilateral inguinal area
- •Is at least 18 years of age at the time of consent
- •Has an Eastern Cooperative Oncology Group (ECOG) performance status of Grade 0 to 3
- •If of childbearing potential, the subject has a negative pregnancy test within 48 hours before administration of Lymphoseek, has been surgically sterilized, or has been postmenopausal for at least 1 year
排除标准
- •The subject has had radiation therapy, chemotherapy or immunotherapy within the 30 days prior to Lymphoseek administration
- •Has had previous surgery or node dissection (exclusive of fine needle aspiration) or radiation to node basins that would be involved in the intraoperative lymphatic mapping procedure
- •Has a known allergy to dextran
- •Is breast-feeding or pregnant
- •Before the administration of Lymphoseek, has received any radiopharmaceutical within 7 radioactive half-lives of that radiopharmaceutical
- •Has received an investigational product within the 30 days prior to Lymphoseek administration
研究组 & 干预措施
Lymphoseek - 0.5 mCi, 50 ug
Experimental
A single dose of 50 µg Lymphoseek radiolabeled with 0.5 millicurie (mCi) (18.5 MBq) 99m Tc
干预措施: Lymphoseek (Drug)
结局指标
主要结局
Concordance (the proportion of the number of subjects with lymph nodes identified by Lymphoseek and standard of care methods compared to the number of subjects with lymph nodes identified by standard of care methods)
时间窗: 2-5 Days
次要结局
- Reverse Concordance (the proportion of the number of subjects with lymph nodes identified by Lymphoseek and standard of care methods compared to the number of subjects with lymph nodes identified by Lymphoseek)(2-5 Days)
- Nodal Concordance (the proportion of the number lymph nodes identified by Lymphoseek and standard of care methods compared to the number of lymph nodes identified by standard of care methods)(2-5 Days)
- Reverse Nodal Concordance (the proportion of the number lymph nodes identified by Lymphoseek and standard of care methods compared to the number of lymph nodes identified by Lymphoseek)(2-5 Days)
- Incidence of Adverse Events(5 Days)
研究者
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