Magnetic Sentinel Lymph Node Mapping in Gastric Cancer, Safety and Feasibility Clinical Trial
M.D. Anderson Cancer Center
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.
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 stat…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- ProcedureGastrectomy
Undergo surgery
- DrugIndocyanine Green
Given peritumorally
- OtherIron Conjugated Polymers in Saline Suspension
Given peritumorally
Location
- M D Anderson Cancer CenterHouston, Texas