Magnetic Sentinel Lymph Node Mapping in Gastric Cancer

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT05038098
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Gastric Adenocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Gastrectomy — PROCEDURE
    Undergo surgery
  • Indocyanine Green — DRUG
    Given peritumorally
  • Iron Conjugated Polymers in Saline Suspension — OTHER
    Given peritumorally

Study Details

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.

Key Dates

Start date
Mar 31, 2026
Status verified
Mar 2026
Primary completion
Feb 2, 2027
Completion
Feb 2, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Cohort I (preoperative injection)
    Patients receive FerroTrace peritumorally within days 1-21. Patients then undergo gastrectomy and receive ICG peritumorally.
  • Experimental: Cohort II (intraoperative)
    Patients undergo gastrectomy and receive FerroTrace and ICG peritumorally during surgery.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030
Naruhiko Ikoma
[email protected]
713-792-6940
Naruhiko Ikoma (PRINCIPAL_INVESTIGATOR)

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By research site
M D Anderson Cancer Center· Houston, TX

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