Trial Summary
What is the purpose of this trial?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.
Eligibility Criteria
This trial is for adults with biopsy-proven gastric cancer, planning to undergo surgery (gastrectomy), without cancer spread beyond the stomach. Participants must consent and have a tumor size of 4 cm or less. It's not for those allergic to iron oxide or iodides, with iron overload disorders, pregnant or breastfeeding women.Inclusion Criteria
I am 18 years old or older.
I have been diagnosed with stomach cancer.
Willing to provide informed consent
+3 more
Exclusion Criteria
I am using birth control during the study.
Allergy or intolerance to iron oxide compounds
I have an iron overload disorder.
+3 more
Participant Groups
The study tests FerroTrace (a magnetic tracer) combined with indocyanine green dye during gastrectomy in gastric cancer patients. This combo aims to better identify lymph nodes where cancer might have spread, potentially improving disease detection.
2Treatment groups
Experimental Treatment
Group I: Cohort II (intraoperative)Experimental Treatment3 Interventions
Patients undergo gastrectomy and receive FerroTrace and ICG peritumorally during surgery.
Group II: Cohort I (preoperative injection)Experimental Treatment3 Interventions
Patients receive FerroTrace peritumorally within days 1-21. Patients then undergo gastrectomy and receive ICG peritumorally.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
M D Anderson Cancer CenterHouston, TX
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Who Is Running the Clinical Trial?
M.D. Anderson Cancer CenterLead Sponsor