Single Dose Investigator Initiated Pilot Study to Investigate CYTALUX (Pafolacianine) for Intraoperative Imaging of Patients With Endometrial Cancer Planned for Surgery
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Primary Endpoint
研究概览
简要总结
The research study is being done to assess the safety and ability of an investigational drug called CYTALUX (pafolacianine) and a special camera system for the detection of cancer in patients undergoing surgical resection for endometrial cancer.
详细描述
Study participant's medical history (questions about their health) will be reviewed with them before their surgery to ensure they are able to participate in the study.
It is important for study participants to tell their doctor if they are taking vitamins that contain Folic Acid (vitamin B9), or Folic Acid (vitamin B9) supplements. They will need to stop taking these vitamins at least 48 hours before their scheduled infusion. Folic acid can reduce the effectiveness of the CYTALUX (pafolacianine). Certain other medications have not been studied together with CYTALUX (pafolacianine), so it is important for them to tell their doctor about all medicines and supplements they are taking.
Screening Visit (To see if they can take part in the study and will take place no more than 30 days before surgery)
The following will take place during the Screening Visit. These tests could include those that their doctor would do before any major surgery, in which case they may not be repeated for this trial.
• The doctor and/or a member of the doctor's team will ask them about their health, and obtain a list of all medications, including vitamins and over-the-counter medications (medicines obtained without a doctor's prescription), that they are taking.
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
- •Provision of signed and dated informed consent form
- •Adult subjects 18 years of age and older
- •Primary diagnosis of endometrial cancer
- •Scheduled to undergo surgery for endometrial cancer
- •Ability to understand the requirements of the study and agree to abide by the study restrictions and to return for the required assessments
- •Willingness to stop the use of folate or folic acid supplements at least 48 hours prior to infusion of study drug
排除标准
- •Pregnancy or positive pregnancy test
- •Any medical condition that in the opinion of the investigator could potentially jeopardize the safety of the subject
- •History of anaphylactic reactions to products containing indocyanine green
- •History of allergy to any of the components of CYTALUX
- •Presence of any psychological, familial, sociological condition or geographical challenges potentially hampering compliance with the study protocol or follow-up schedule
研究组 & 干预措施
CYTALUX™ (pafolacianine) injection and standard care laparoscopic evaluation of disease.
single dose, open-label, pilot study of single dose of CYTALUX (pafolacianine) injection
干预措施: CYTALUX™ (pafolacianine) (Drug)
CYTALUX™ (pafolacianine) injection and standard care laparoscopic evaluation of disease.
single dose, open-label, pilot study of single dose of CYTALUX (pafolacianine) injection
干预措施: 1788 4K Camera System with Advanced Imaging Modality (Device)
结局指标
主要结局
Primary Endpoint
时间窗: 2 months after surgery
The primary efficacy endpoint is the sensitivity of CYTALUX with NIR imaging for detection of malignant lesions. Sensitivity is defined as the proportion of fluorescent light positive lesions that are histologically confirmed to be cancer relative to the total number of lesions confirmed to be cancer. Sensitivity = (True Positive)/(True Positive + False Negative)
次要结局
- Secondary Endpoints(2 months after surgery)