Magnetic Sentinel Lymph Node Mapping in Gastric Cancer

This study is looking at how safe and effective it is to use a magnetic tracer called FerroTrace and a fluorescent dye called Indocyanine Green to find lymph nodes where gastric cancer (stomach cancer) might have spread. You could be eligible if you are 18 or older, have gastric cancer that hasn't spread to distant parts of your body, and are having surgery to remove the cancer. The study aims to see if using FerroTrace and Indocyanine Green can help doctors better detect the disease. The study is currently unclear on its recruitment status and plans to enroll 20 participants.

Study design
This interventional study plans to enroll 20 participants and assigns them to one of two groups for receiving the study interventions.
What's involved
You would undergo gastrectomy (surgery to remove part or all of your stomach) and receive injections of FerroTrace and Indocyanine Green either before or during surgery.
Compensation
Not stated in the trial record.
Follow-up
Your safety will be assessed within 24 hours of the FerroTrace injection.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05038098

Magnetic Sentinel Lymph Node Mapping in Gastric Cancer

Not Yet Recruiting
PHASE1Ages 18+InterventionalDiagnostic
M.D. Anderson Cancer Center
~20 participants
Updated 2026-08-14 on ClinicalTrials.gov
What's tested:GastrectomyIndocyanine GreenIron Conjugated Polymers in Saline Suspension

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety of endoscopic peritumoral gastric injection of FerroTrace
Measured over Within 24 hours of the FerroTrace injection
Gastric Adenocarcinoma

NCT05038098

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • M D Anderson Cancer Center

    Houston, Texasstudy coordinator listed

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

  • Naruhiko Ikoma · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

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Eligibility criteria

Inclusion

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

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
  • Safety of endoscopic peritumoral gastric injection of FerroTraceWithin 24 hours of the FerroTrace injection

    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.