A Prospective, Open-Label, Multicenter Study of Lymphoseek® as a Lymphoid Tissue Targeting Agent in Pediatric Patients With Melanoma, Rhabdomyosarcoma, or Other Solid Tumors Who Are Undergoing Lymph Node Mapping
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 6
- 主要终点
- Average Number of Lymph Nodes Identified Intraoperatively Per Subject
研究概览
简要总结
Open label, non-randomized, multi-center, within-subject comparative study to evaluate the tolerability and the diagnostic utility of Lymphoseek with optional comparison to VBD in pediatric subjects with melanoma, rhabdomyosarcoma, or other solid tumor. Subject age will range from neonatal through 17 years.
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
- — 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject's parent(s)/legal guardian(s) understand(s) and voluntarily signed an informed consent document prior to any study-related assessments/procedures being conducted. Where locally applicable, the subject also understands and voluntarily provides his/her assent prior to any study-related assessments/procedures being conducted
- •Subject has been diagnosed with melanoma, rhabdomyosarcoma, or other tumor where tumor resection or biopsy is planned and lymph node mapping is appropriate
- •The subject is clinically node negative (cN0) at the time of screening
- •Age < 18 years
- •Male subjects of childbearing potential must be willing to use a condom during sexual intercourse and shall not father a child during the course of the study or will practice complete abstinence while on study
- •Female subjects of childbearing potential must agree to the use of two physician-approved contraceptive methods simultaneously or practice complete abstinence while on study
排除标准
- •The subject has had preoperative radiation therapy
- •Has had previous surgery or radiation to node basins that would be involved in the intraoperative lymph node mapping (ILM) procedure
- •Has a known allergy to dextran or VBD (if intended to be used)
- •Has a history of alcohol abuse or alcohol dependency in the 3 years before study entry, or is an alcoholic or drug addict, as determined by the investigator
- •Before the administration of Lymphoseek, has received any radiopharmaceutical within 7 radioactive half-lives of that radiopharmaceutical
研究组 & 干预措施
Tc99m tilmanocept and Vital Blue Dye (optional)
0.5 mCi, 50 ug of Tc99m tilmanocept single administration. Optionally, 1-3 mL of vital blue dye, single administration (per institution's standard of care).
干预措施: Tc99m tilmanocept (Drug)
Tc99m tilmanocept and Vital Blue Dye (optional)
0.5 mCi, 50 ug of Tc99m tilmanocept single administration. Optionally, 1-3 mL of vital blue dye, single administration (per institution's standard of care).
干预措施: Vital Blue Dye (optional) (Drug)
Tc99m tilmanocept and Vital Blue Dye (optional)
0.5 mCi, 50 ug of Tc99m tilmanocept single administration. Optionally, 1-3 mL of vital blue dye, single administration (per institution's standard of care).
干预措施: Lymph Node Mapping (Procedure)
结局指标
主要结局
Average Number of Lymph Nodes Identified Intraoperatively Per Subject
时间窗: 1 Day
Subject Localization Rates
时间窗: 1 Day
The proportion of subjects with Lymphoseek-identified lymph nodes
次要结局
- Average Number of Lymph Nodes Identified Preoperatively Using SPECT or SPECT/CT Per Subject(1 Day)
- Proportion of Subjects Who Underwent Preoperative SPECT or SPECT/CT(1 Day)
- Agreement of the Number of Nodes Identified by Preoperative SPECT or SPECT/CT to Intraoperative Localization(1 Day)
- Proportion of Subjects With a Lymph Node Identified Preoperatively Using SPECT or SPECT/CT(1 day)
- Upstaging(1 Day)
- Nodal False Negative Rate for Nodes Identified(1 Day)
- Number of Changes in Postsurgical Treatment Plan in Relation to Nodes Identified by Lymphoseek(1 Day)
- Nodal Sensitivity(1 Day)
- Nodal Agreement of Central Pathology Assessment With Local Pathology Assessment of the Excised Lymph Node(s) to Confirm the Presence/Absence of Tumor Metastases(1 Day)
- Change in Subject Nodal Staging Before and After Surgery Based Upon Nodes Identified(1 Day)