Clinical trial · Interventional
Magnetic Sentinel Lymph Node Mapping in Gastric Cancer
Magnetic Sentinel Lymph Node Mapping in Gastric Cancer, Safety and Feasibility Clinical Trial
NCT05038098CI-TRIAL-00122192not yet recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Adenocarcinoma | Gastric Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gastrectomy | Procedure | — | UNRESOLVED |
| Indocyanine Green | Drug | — | UNRESOLVED |
| Iron Conjugated Polymers in Saline Suspension | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Cohort I (preoperative injection)
- description
- Patients receive FerroTrace peritumorally within days 1-21. Patients then undergo gastrectomy and receive ICG peritumorally.
- interventionNames
- Procedure: Gastrectomy
- Drug: Indocyanine Green
- Other: Iron Conjugated Polymers in Saline Suspension
- type
- EXPERIMENTAL
- label
- Cohort II (intraoperative)
- description
- Patients undergo gastrectomy and receive FerroTrace and ICG peritumorally during surgery.
- interventionNames
- Procedure: Gastrectomy
- Drug: Indocyanine Green
- Other: Iron Conjugated Polymers in Saline Suspension
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.