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Magnetic Lymph Node Mapping for Stomach Cancer

Phase 1
Waitlist Available
Led By Naruhiko Ikoma
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18 or older
Pathologic diagnosis of gastric adenocarcinoma
Must not have
Iron overload disorder
Contraindications to surgery +/- adjuvant therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 24 hours of the ferrotrace injection
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new way to find cancer spread in the lymph nodes of people with gastric cancer. They will be using a magnetic tracer and a fluorescent dye. If it is effective, this could help researchers better detect the disease.

Who is the study for?
This trial is for adults with biopsy-proven gastric cancer, planning to undergo surgery (gastrectomy), without cancer spread beyond the stomach. Participants must consent and have a tumor size of 4 cm or less. It's not for those allergic to iron oxide or iodides, with iron overload disorders, pregnant or breastfeeding women.
What is being tested?
The study tests FerroTrace (a magnetic tracer) combined with indocyanine green dye during gastrectomy in gastric cancer patients. This combo aims to better identify lymph nodes where cancer might have spread, potentially improving disease detection.
What are the potential side effects?
Possible side effects may include reactions to the magnetic tracer or dye such as allergies, skin discoloration at injection site, and general discomfort. Since this is an investigational procedure, there may be unknown risks involved.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I have been diagnosed with stomach cancer.
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I have gastric cancer confirmed by biopsy and am having surgery to remove it.
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My cancer has not spread to distant parts of my body.
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My stomach cancer is 4 cm or smaller, as measured before treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have an iron overload disorder.
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I cannot undergo surgery or receive additional treatment after surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 24 hours of the ferrotrace injection
This trial's timeline: 3 weeks for screening, Varies for treatment, and within 24 hours of the ferrotrace injection for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Safety of endoscopic peritumoral gastric injection of FerroTrace

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Cohort II (intraoperative)Experimental Treatment3 Interventions
Patients undergo gastrectomy and receive FerroTrace and ICG peritumorally during surgery.
Group II: Cohort I (preoperative injection)Experimental Treatment3 Interventions
Patients receive FerroTrace peritumorally within days 1-21. Patients then undergo gastrectomy and receive ICG peritumorally.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gastrectomy
2017
Completed Phase 2
~1330
Indocyanine Green
2008
Completed Phase 2
~1050

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,074 Previous Clinical Trials
1,803,571 Total Patients Enrolled
Naruhiko IkomaPrincipal InvestigatorM.D. Anderson Cancer Center

Media Library

Gastrectomy Clinical Trial Eligibility Overview. Trial Name: NCT05038098 — Phase 1
Stomach Cancer Research Study Groups: Cohort II (intraoperative), Cohort I (preoperative injection)
Stomach Cancer Clinical Trial 2023: Gastrectomy Highlights & Side Effects. Trial Name: NCT05038098 — Phase 1
Gastrectomy 2023 Treatment Timeline for Medical Study. Trial Name: NCT05038098 — Phase 1
~13 spots leftby Feb 2027
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