NCT02509585终止2 期
A Prospective, Open-Label Trial of Comparing the Pathology Status of Lymphoseek®-Identified Sentinel Lymph Nodes Relative to the Pathological Pathology Status of Nonsentinel Lymph Nodes in Nodal Staging of Subjects With Known Cancer of the Cervix Who Are Undergoing Lymph Node Dissection
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 18
- 试验地点
- 4
- 主要终点
- Per-subject False Negative Rate
研究概览
简要总结
Prospective, open-label, within-patient, multi-center study of Lymphoseek in the detection of lymph nodes in subjects with known cancer of the cervix. All subjects will receive a single dose of 50 µg Lymphoseek radiolabeled with 2 mCi (74 MBq) Tc 99m.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Subject has provided written informed consent with HIPAA authorization
- •Has cervical cancer and is a candidate for surgical intervention, with lymph node dissection being a part of the surgical plan.
- •Is at least 18 years of age at the time of consent
- •Has an ECOG performance status of Grade 0 to 2
- •Has the following International Federation of Gynecology and Obstetrics (FIGO) IA2-IIA1staging. Subjects with a single enlarged/suspicious node on PET/CT will still be considered eligible as consistent with FIGO guidelines.
- •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 preoperative chemotherapy, immunotherapy, or radiation therapy within the 30 days prior to Lymphoseek administration
- •Has had previous surgery or radiation to node basins that would be involved in the ILM 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
- •Is scheduled for surgery and/or another invasive procedure other than the primary surgical intervention within the 3 days after Lymphoseek administration
- •Has received an investigational product within the 30 days prior to Lymphoseek administration
研究组 & 干预措施
Tc99m tilmanocept
Experimental
2 mCi (74 MBq), 50 ug of Tc99M tilmanocept single administration
干预措施: Tc99m tilmanocept (Drug)
结局指标
主要结局
Per-subject False Negative Rate
时间窗: 1 day
Proportion of subjects with pathologically negative Lymphoseek-identified SLNs and at least one pathologically positive non-SLN
次要结局
- Number of Lymph Nodes Per-subject Identified by Lymphoseek(1 day)
- Per-subject Concordance(1 day)
- Per-subject Reverse Concordance(1 day)
- Per-subject Sensitivity(1 day)
- Per-subject Negative Predictive Value(1 day)
- Proportion of Lymph Nodes Identified Intraoperatively by a Dye That Are Also Identified by Lymphoseek(1 day)
- Number of Lymph Nodes Per-subject Identified by Other Dyes(1 day)
- Per-subject Accuracy(1 day)
- Incidence of Adverse Events(7 days)
研究者
研究点 (4)
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