Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT05038098

Magnetic Sentinel Lymph Node Mapping in Gastric Cancer

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Gastric Adenocarcinoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location contact

Naruhiko Ikoma

CONTACT

[email protected]

713-792-6940

Naruhiko Ikoma

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 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

Treatment and study plan

gastrectomy

Procedure

Undergo surgery

Other names: Gastric Resection

Indocyanine green

Drug

Given peritumorally

Other names: ICG

Iron Conjugated Polymers in Saline Suspension

Other

Given peritumorally

Other names: FerroTrace

Primary outcomes

  1. Safety of endoscopic peritumoral gastric injection of FerroTrace

    Time frame: Within 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Naruhiko Ikoma, MD

CONTACT

[email protected]

832-729-2675

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Registry information

Official study title

Magnetic Sentinel Lymph Node Mapping in Gastric Cancer, Safety and Feasibility Clinical Trial

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 8, 2021
Registry last updated
Mar 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.