Clinical trial NCT05038098: Magnetic Sentinel Lymph Node Mapping in Gastric Cancer
Official title: Magnetic Sentinel Lymph Node Mapping in Gastric Cancer, Safety and Feasibility Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Gastric Adenocarcinoma
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2021-09-08
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Safety of endoscopic peritumoral gastric injection of FerroTrace
timeFrame: Within 24 hours of the FerroTrace injection
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Naruhiko Ikoma
role: PRINCIPAL_INVESTIGATOR
References: