Post-market Safety Study of LUMISIGHT
2026年4月30日 更新者：Lumicell, Inc.
Post-market Evaluation of Incidence Rate of Anaphylaxis and Hypersensitivity Reactions Associated With LUMISIGHT Administration
This study is a prospective, multi-center, observational post-market safety study evaluating the incidence of anaphylaxis and hypersensitivity reactions associated with LUMISIGHT (pegulicianine) administration in adults with breast cancer undergoing lumpectomy surgery.
Participants are indicated to receive LUMISIGHT as part of their breast cancer care.
There is no investigational drug associated with this study.
LUMISIGHT has a risk of serious hypersensitivity reaction, and this study seeks to further evaluate that risk.
研究概览
地位
尚未招聘
条件
详细说明
The LumiSystem is the combination of FDA approved LUMISIGHT (pegulicianine) for injection (NDA 214511) and Lumicell Direct Visualization System (DVS) (PMA P230014).
These products are indicated for fluorescence imaging in adults with breast cancer as an adjunct for the intraoperative detection of cancerous tissue within the resection cavity following removal of the primary specimen during lumpectomy surgery.
This post market study is a prospective, multi-center, observational post-market safety study evaluating the incidence of anaphylaxis and hypersensitivity reactions associated with LUMISIGHT (pegulicianine) administration in adults with breast cancer undergoing lumpectomy surgery.
Additional study objectives are to evaluate the incidence of and characterize other severe hypersensitivity reactions.
Study assessments include assessment of adverse events of interest (including laboratory data as indicated in this protocol), physical examination, and assessment of blood pressure, heart rate, and oxygen saturation before and after LUMISIGHT administration.
Suspected cases of anaphylaxis and hypersensitivity reactions are adjudicated by a Clinical Endpoint Adjudication Committee according to a standard anaphylaxis definition and hypersensitivity grading system.
研究类型
观察性的
注册 (估计的)
1500
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：VP, Clinical Affairs and Pharmacovigilance
- 电话号码：6174041033
- 邮箱：kate@lumicell.com
研究联系人备份
- 姓名：Senior Clinical Trial Manager
- 邮箱：ppalacios@lumicell.com
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
取样方法
非概率样本
研究人群
The analysis population consists of the post-market safety population who are injected with LUMISIGHT.
The post-market safety population is defined by the indication for use and contraindications as described in the Prescribing Information for LUMISIGHT under NDA 214511.
描述
Inclusion Criteria:
- 18 years of age or older
- Has been diagnosed with primary breast cancer and scheduled to undergo a lumpectomy procedure
- Indicated to receive LUMISIGHT at a dose of 1 mg/kg
- Willing and able to comply with the study procedures
Exclusion Criteria:
- History of hypersensitivity reactions to pegulicianine.
- Inability to comply with the requirements of the protocol.
- Treating physician does not think it is in the best interest of the patient to participate.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
|---|
|
Post-market safety population injected with LUMISIGHT
The analysis population consists of the post-market safety population who are injected with LUMISIGHT.
The post-market safety population is defined by the indication for use and contraindications as described in the Prescribing Information for LUMISIGHT under NDA 214511.
|
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 |
|---|---|---|
|
Incidence of adjudicated anaphylaxis
大体时间：75 +/- 15 minutes post LUMISIGHT injection
|
Evaluate the rate of adjudicated anaphylaxis observed within 60-minutes post-injection of LUMISIGHT
|
75 +/- 15 minutes post LUMISIGHT injection
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Incidence of adjudicated serious hypersensitivity reactions
大体时间：75 +/- 15 minutes post LUMISIGHT injection
|
Evaluate the rate of adjudicated serious hypersensitivity reactions observed within 60 minutes post-injection of LUMISIGHT.
|
75 +/- 15 minutes post LUMISIGHT injection
|
|
Incidence of hypersensitivity reactions
大体时间：75 +/- 15 minutes post LUMISIGHT injection
|
Evaluate the rate of hypersensitivity reactions observed within 60 minutes post-injection of LUMISIGHT.
|
75 +/- 15 minutes post LUMISIGHT injection
|
|
Distribution of severity of adjudicated hypersensitivity reactions
大体时间：75 +/- 15 minutes post LUMISIGHT injection
|
Evaluate the distribution of adjudicated severity of observed hypersensitivity reactions.
|
75 +/- 15 minutes post LUMISIGHT injection
|
|
Descriptive statistics of population with occurrence of adjudicated anaphylaxis.
大体时间：75 +/- 15 minutes of LUMISIGHT injection
|
Characterize risk factors (e.g.
patient characteristics, medical history, duration of drug exposure) associated with the occurrence of adjudicated anaphylaxis among patients exposed to LUMISIGHT.
|
75 +/- 15 minutes of LUMISIGHT injection
|
|
Descriptive statistics of population with occurrence of adjudicated severe hypersensitivity reactions.
大体时间：75 +/- 15 minutes post LUMISIGHT injection
|
Characterize risk factors (e.g.
patient characteristics, medical history, duration of drug exposure) associated with the occurrence of adjudicated severe hypersensitivity reaction (Grade ≥ 3) among patients exposed to LUMISIGHT.
|
75 +/- 15 minutes post LUMISIGHT injection
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change from baseline is tryptase levels for the population that experiences a hypersensitivity event
大体时间：60 days post hypersensitivity reaction
|
Characterize the mechanism of action of hypersensitivity reactions occurring after administration of LUMISIGHT by providing a descriptive analysis for tryptase levels in blood and changes from baseline.
|
60 days post hypersensitivity reaction
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Jorge Ferrer, PhD、Lumicell, Inc.
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年6月1日
初级完成 (估计的)
2030年12月1日
研究完成 (估计的)
2030年12月1日
研究注册日期
首次提交
2026年4月30日
首先提交符合 QC 标准的
2026年4月30日
首次发布 (实际的)
2026年5月7日
研究记录更新
最后更新发布 (实际的)
2026年5月7日
上次提交的符合 QC 标准的更新
2026年4月30日
最后验证
2026年4月1日
更多信息
与本研究相关的术语
关键字
其他相关的 MeSH 术语
其他研究编号
- CLP00203
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
在美国制造并从美国出口的产品
不
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