Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE1
20 participants
INTERVENTIONAL
2026-03-31
2027-02-02
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Cohort I (preoperative injection)
Patients receive FerroTrace peritumorally within days 1-21. Patients then undergo gastrectomy and receive ICG peritumorally.
Gastrectomy
Undergo surgery
Indocyanine Green
Given peritumorally
Iron Conjugated Polymers in Saline Suspension
Given peritumorally
Cohort II (intraoperative)
Patients undergo gastrectomy and receive FerroTrace and ICG peritumorally during surgery.
Gastrectomy
Undergo surgery
Indocyanine Green
Given peritumorally
Iron Conjugated Polymers in Saline Suspension
Given peritumorally
Interventions
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Gastrectomy
Undergo surgery
Indocyanine Green
Given peritumorally
Iron Conjugated Polymers in Saline Suspension
Given peritumorally
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Naruhiko Ikoma
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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M D Anderson Cancer Center
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Related Links
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M D Anderson Cancer Center
Other Identifiers
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NCI-2021-08919
Identifier Type: REGISTRY
Identifier Source: secondary_id
2021-0410
Identifier Type: OTHER
Identifier Source: secondary_id
2021-0410
Identifier Type: -
Identifier Source: org_study_id
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