The Impact of Pafolacianine Injection for Intraoperative Imaging on Outcomes of Gastrointestinal Cancer Peritoneal Carcinomatosis - A Pilot Study
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Specificity-True Negative Rate (TNR)
研究概览
简要总结
This is a pilot, single-arm, open label study to evaluate the ability of CYTALUX™ (pafolacianine) to help identify cancerous lesions in subjects with gastrointestinal cancers and peritoneal carcinomatosis during cytoreductive surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Adult patients 18 years of age and older
- •Have a primary diagnosis of primary gastrointestinal cancer (of adenocarcinoma), planned for cytoreductive surgery
- •Female patients must have a negative serum pregnancy test at screening, followed by a negative urine pregnancy test on the day of scheduled study drug infusion, or day of surgery
- •Female patients of childbearing potential, or less than two (2) years postmenopausal, agree to use an acceptable form of contraception from time of signing informed consent until 30 days after study completion
- •Ability to understand the requirements of the study, provide written informed consent for participation in the study and authorization of use and disclosure of protected health information, and agree to abide by study restrictions
排除标准
- •Previous exposure to CYTALUX™ (PAFOLACIANINE)
- •Patients with known gastrointestinal cancer with carcinomatosis determined pre-operatively to be inoperable
- •Any medical condition that in the opinion of the investigators could potential jeopardize the safety of the patient
- •History of anaphylactic reaction
- •History of allergy to any components of CYTALUX™ (PAFOLACIANINE), including folic acid
- •Pregnancy, or positive pregnancy test
- •Clinically significant abnormalities on ECG
- •Impaired renal function defined as eGFR <50 mL/min/1.73m2
- •Impaired liver function defined as values >3x the upper limit of normal (ULN) for alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), or total bilirubin
- •Received an investigational agent in another trial within 30 days prior to surgery
- •Known sensitivity to fluorescent light
研究组 & 干预措施
Pafolacianine (CYTALUX)
All subjects will receive one single intravenous infusion of 0.025 mg/kg of pafolacianine (CYTALUX) injection prior to anticipated intraoperative imaging planned for cytoreductive surgery.
干预措施: Pafolacianine (CYTALUX) with intraoperative fluorescent near-infrared (NIR) imaging (Drug)
结局指标
主要结局
Specificity-True Negative Rate (TNR)
时间窗: 1 year
Specificity, or the True Negative Rate (TNR), is defined as the proportion of fluorescent light negative lesions that are histologically negative for gastrointestinal cancer and FR- by central pathology, relative to the total number of lesions that are negative for gastrointestinal cancer (FR-) by central pathology-that is, the proportion of non-cancer lesions that are fluorescent light negative.
Positive Predictive Value (PPV)
时间窗: 1 year
Positive Predictive Value (PPV) is defined as the proportion of fluorescent light positive lesions that are histologically confirmed to be FR+ and gastrointestinal cancer by central pathology relative to the total number of lesions removed that are fluorescent light positive-that is, the proportion of fluorescent light positive lesions that are cancerous.
Negative Predictive Value (NPV)
时间窗: 1 year
Negative Predictive Value (NPV) is defined as the proportion of fluorescent light negative lesions that are histologically negative for gastrointestinal cancer and FR- by central pathology relative to the total number of lesions removed that are fluorescent light negative-that is, the proportion of fluorescent light negative lesions that are histologically negative for cancer.
Accuracy
时间窗: 1 year
Accuracy is defined as the proportion of fluorescent light positive lesions that are histologically confirmed to be FR+ and gastrointestinal cancer by central pathology and the fluorescent light negative lesions that are histologically negative for gastrointestinal cancer and FR- by central pathology relative to all lesions sampled.
Cytoreduction (CC) Score
时间窗: 1 year
Describe the completeness of cytroreduction (cc) score with Cytoreductive surgery (CRS) with Cytalux injection.
Sensitivity-True Positive Rate (TPR)
时间窗: 1 year
Sensitivity, or the True Positive Rate (TPR), is defined as the proportion of fluorescent light positive lesions that are histologically confirmed to be gastrointestinal cancer (and folate receptor (FR) positive) by central pathology relative to the total number of lesions confirmed to be gastrointestinal cancer (FR+) by central pathology, that is proportion of cancerous lesions that are fluorescent light positive.
次要结局
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability](30 days)
研究者
Maheswari Senthil, MD
Professor of Surgery
University of California, Irvine