Magnetic Sentinel Lymph Node Mapping in Gastric Cancer
2 other identifiers
interventional
20
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Mar 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 27, 2021
CompletedFirst Posted
Study publicly available on registry
September 8, 2021
CompletedStudy Start
First participant enrolled
March 31, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 2, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 2, 2027
March 5, 2026
March 1, 2026
10 months
August 27, 2021
March 3, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Cohort I (preoperative injection)
EXPERIMENTALPatients receive FerroTrace peritumorally within days 1-21. Patients then undergo gastrectomy and receive ICG peritumorally.
Cohort II (intraoperative)
EXPERIMENTALPatients undergo gastrectomy and receive FerroTrace and ICG peritumorally during surgery.
Interventions
Undergo surgery
Given peritumorally
Given peritumorally
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
M D Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Naruhiko Ikoma
M.D. Anderson Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 27, 2021
First Posted
September 8, 2021
Study Start
March 31, 2026
Primary Completion (Estimated)
February 2, 2027
Study Completion (Estimated)
February 2, 2027
Last Updated
March 5, 2026
Record last verified: 2026-03