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Magnetic Sentinel Lymph Node Mapping in Gastric Cancer

Sponsor
M.D. Anderson Cancer Center (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05038098
Collaborator
(none)
20
Enrollment
1
Location
2
Arms
33.1
Anticipated Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Gastrectomy
  • Drug: Indocyanine Green
  • Other: Iron Conjugated Polymers in Saline Suspension
 Phase 1

Detailed Description

PRIMARY OBJECTIVE:
  1. To assess safety by assessing short term toxicity associated with the gastric injection of the novel magnetic tracer.
SECONDARY OBJECTIVES:

  1. 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.

  2. 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Magnetic Sentinel Lymph Node Mapping in Gastric Cancer, Safety and Feasibility Clinical Trial
Anticipated Study Start Date :
Mar 30, 2022
Anticipated Primary Completion Date :
Dec 31, 2024
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cohort I (preoperative injection)

Patients receive FerroTrace peritumorally within days 1-21. Patients then undergo gastrectomy and receive ICG peritumorally.

Procedure: Gastrectomy
Undergo surgery
Other Names:
  • Gastric Resection

    • Drug: Indocyanine Green
    Given peritumorally
    Other Names:
  • ICG

    • Other: Iron Conjugated Polymers in Saline Suspension
    Given peritumorally
    Other Names:
  • FerroTrace

    		•
    Experimental: Cohort II (intraoperative)

    Patients undergo gastrectomy and receive FerroTrace and ICG peritumorally during surgery.

    Procedure: Gastrectomy
    Undergo surgery
    Other Names:
  • Gastric Resection

    • Drug: Indocyanine Green
    Given peritumorally
    Other Names:
  • ICG

    • Other: Iron Conjugated Polymers in Saline Suspension
    Given peritumorally
    Other Names:
  • FerroTrace

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Safety of endoscopic peritumoral gastric injection of FerroTrace [Within 24 hours of the FerroTrace injection]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 M D Anderson Cancer Center Houston Texas United States 77030

    Sponsors and Collaborators

    • M.D. Anderson Cancer Center

    Investigators

    • Principal Investigator: Naruhiko Ikoma, M.D. Anderson Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    M.D. Anderson Cancer Center
    ClinicalTrials.gov Identifier:
    NCT05038098
    Other Study ID Numbers:
    • 2021-0410
    • NCI-2021-08919
    • 2021-0410
    First Posted:
    Sep 8, 2021
    Last Update Posted:
    Feb 21, 2022
    Last Verified:
    Feb 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Additional relevant MeSH terms:
    Adenocarcinoma
    Stomach Neoplasms

    Study Results

    No Results Posted as of Feb 21, 2022