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NCT05038098 Clinical Trial

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
First received
Last updated
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
Health authority
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

Study Design

Related Conditions & MeSH terms

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
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