Magnetic Sentinel Lymph Node Mapping in Gastric Cancer

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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. OUTLINE: Patients are assigned to 1 of 2 cohorts. COHORT I (PREOPERATIVE INJECTION): Patients receive FerroTrace peritumorally within days 1-21. Patients then undergo gastrectomy and receive indocyanine green (ICG) peritumorally. COHORT II (INTRAOPERATIVE INJECTION): Patients undergo gastrectomy and receive FerroTrace and ICG peritumorally during surgery.

Official Title
-----------------
Magnetic Sentinel Lymph Node Mapping in Gastric Cancer, Safety and Feasibility Clinical Trial

Conditions
-----------------
Gastric Adenocarcinoma

Intervention / Treatment
-----------------
* Procedure: Gastrectomy
* Drug: Indocyanine Green
* Other: Iron Conjugated Polymers in Saline Suspension


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort I (preoperative injection)<br>Patients receive FerroTrace peritumorally within days 1-21. Patients then undergo gastrectomy and receive ICG peritumorally. | Procedure: Gastrectomy<br>* Undergo surgery<br>* Other names: Gastric Resection;Drug: Indocyanine Green<br>* Given peritumorally<br>* Other names: ICG;Other: Iron Conjugated Polymers in Saline Suspension<br>* Given peritumorally<br>* Other names: FerroTrace;|
| Experimental: Cohort II (intraoperative)<br>Patients undergo gastrectomy and receive FerroTrace and ICG peritumorally during surgery. | Procedure: Gastrectomy<br>* Undergo surgery<br>* Other names: Gastric Resection;Drug: Indocyanine Green<br>* Given peritumorally<br>* Other names: ICG;Other: Iron Conjugated Polymers in Saline Suspension<br>* Given peritumorally<br>* Other names: FerroTrace;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of endoscopic peritumoral gastric injection of FerroTrace | 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. | Within 24 hours of the FerroTrace injection |