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.
Additional locations may be listed on ClinicalTrials.gov for NCT05038098.
Locations matching your search criteria
United States
Texas
Houston
M D Anderson Cancer CenterStatus: Approved
Contact: Naruhiko Ikoma
Phone: 713-792-6940
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.
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorNaruhiko Ikoma
