A Phase 1 interventional study of Gastrectomy and Indocyanine Green in Gastric Adenocarcinoma, sponsored by M.D. Anderson Cancer Center. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-14.
Sponsored by M.D. Anderson Cancer Center · Phase 1, Interventional, and Diagnostic
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.
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.
M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 581 are open to participants now.
Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Pregnant or lactating women*
Patients receive FerroTrace peritumorally within days 1-21. Patients then undergo gastrectomy and receive ICG peritumorally.
Procedure: Gastrectomy · Drug: Indocyanine Green · Other: Iron Conjugated Polymers in Saline Suspension
Patients undergo gastrectomy and receive FerroTrace and ICG peritumorally during surgery.
Procedure: Gastrectomy · Drug: Indocyanine Green · Other: Iron Conjugated Polymers in Saline Suspension
Undergo surgery
Also known as: Gastric Resection
Given peritumorally
Also known as: ICG
Given peritumorally
Also known as: FerroTrace
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.
Time frame: Within 24 hours of the FerroTrace injection
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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M.D. Anderson Cancer Center