Magnetic Sentinel Lymph Node Mapping in Gastric Cancer, Safety and Feasibility Clinical Trial
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Safety of endoscopic peritumoral gastric injection of FerroTrace
研究概览
简要总结
This phase I finds out the possible benefits and/or side effects of using magnetic tracer FerroTrace and the fluorescent dye indocyanine green to identify the lymph nodes that cancer is most likely to have spread to in patients with gastric cancer that are undergoing gastrectomy. Using FerroTrace in combination with the indocyanine green dye may help researchers better detect the disease.
详细描述
PRIMARY OBJECTIVE:
I. To assess safety by assessing short term toxicity associated with the gastric injection of the novel magnetic tracer.
SECONDARY OBJECTIVES:
I. To determine the feasibility of sentinel lymph node (SLN) imaging and mapping using novel magnetic nanoparticles (iron conjugated polymers in saline suspension [FerroTrace]) for gastric cancer, and to determine whether pre-operative injection, intra-operative injection, or both are feasible.
II. To test the validity of this procedure by correlating sentinel lymph nodes (SLN) to predict pathologic Lymph node (LN)-positive status i.e., will a negative SLN accurately predict the negativity of the other LNs? III. To determine the diagnostic value of additional hematoxylin and eosin (H&E) sections and immunohistochemistry to assess sentinel lymph nodes compared to routine assessment with one H&E stain alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 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
- •Age 18 or older
- •Willing to provide informed consent
- •Biopsy proven gastric cancer, undergoing curative-intent gastrectomy
- •No distant metastases
- •Pathologic diagnosis of gastric adenocarcinoma
- •Pre-treatment endoscopic measurement of less than or equal to 4 cm in diameter of the gastric cancer
排除标准
- •Contraindications to surgery +/- adjuvant therapy
- •Allergy or intolerance to iron oxide compounds
- •Allergy or intolerance to iodides
- •Iron overload disorder
- •Pregnant or lactating women*
- •Use of contraception is required for females during the study. Male patients who are sexually active with a female of childbearing potential are allowed for study enrollment and will not require use of contraception
研究组 & 干预措施
Cohort II (intraoperative)
Patients undergo gastrectomy and receive FerroTrace and ICG peritumorally during surgery.
干预措施: Iron Conjugated Polymers in Saline Suspension (Other)
Cohort II (intraoperative)
Patients undergo gastrectomy and receive FerroTrace and ICG peritumorally during surgery.
干预措施: Indocyanine Green (Drug)
Cohort I (preoperative injection)
Patients receive FerroTrace peritumorally within days 1-21. Patients then undergo gastrectomy and receive ICG peritumorally.
干预措施: Gastrectomy (Procedure)
Cohort I (preoperative injection)
Patients receive FerroTrace peritumorally within days 1-21. Patients then undergo gastrectomy and receive ICG peritumorally.
干预措施: Iron Conjugated Polymers in Saline Suspension (Other)
Cohort II (intraoperative)
Patients undergo gastrectomy and receive FerroTrace and ICG peritumorally during surgery.
干预措施: Gastrectomy (Procedure)
Cohort I (preoperative injection)
Patients receive FerroTrace peritumorally within days 1-21. Patients then undergo gastrectomy and receive ICG peritumorally.
干预措施: Indocyanine Green (Drug)
结局指标
主要结局
Safety of endoscopic peritumoral gastric injection of FerroTrace
时间窗: Within 24 hours of the FerroTrace injection
The Bayesian method by Thall et al. will be applied for interim toxicity monitoring. Toxicities are defined as any grade III or greater toxicities attributable to FerroTrace injection, which occur within 24 hours of the injection. Will summarize the rate of adverse events (AEs) in all patients and by cohort, along with the exact 95% confidence interval.
次要结局
未报告次要终点