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Not yet recruiting NCT05038098

Magnetic Sentinel Lymph Node Mapping in Gastric Cancer

Phase I Interventional Gastric Adenocarcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Gastrectomy, Indocyanine Green, Iron Conjugated Polymers in Saline Suspension.
Who it may be relevant to
Registry conditions: Gastric Adenocarcinoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Detailed description

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.

Interventions

  • Procedure Gastrectomy
    Undergo surgery
  • Drug Indocyanine Green
    Given peritumorally
  • Other Iron Conjugated Polymers in Saline Suspension
    Given peritumorally

Primary outcome measures

  • Safety of endoscopic peritumoral gastric injection of FerroTrace [Time frame: Within 24 hours of the FerroTrace injection]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Diagnostic

Study locations

United States · 1 center
  • M D Anderson Cancer Center — Houston

Identifiers

NCT: NCT05038098 · 2021-0410 · NCI-2021-08919 · 2021-0410

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗