Magnetic Sentinel Lymph Node Mapping in Gastric Cancer

Gastric Adenocarcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05038098
• Other study ID #: 2021-0410
• Secondary ID: NCI-2021-0891920
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: April 30, 2024
• Est. completion date: February 2, 2027

Study information

• Verified date: March 2024
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: February 2, 2027
• Est. primary completion date: February 2, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Gastric Adenocarcinoma
• Stomach Neoplasms

Intervention

Procedure:
• Gastrectomy
Undergo surgery

Drug:
• Indocyanine Green
Given peritumorally

Other:
• Iron Conjugated Polymers in Saline Suspension
Given peritumorally

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Within 24 hours of the FerroTrace injection

External Links

•   M D Anderson Cancer Center