Magnetic Lymph Node Mapping for Stomach Cancer

Overseen By Naruhiko Ikoma, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Iron allergy, Iodide allergy, Iron overload, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

20 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment FerroTrace, Indocyanine Green, ICG for stomach cancer?

Research shows that indocyanine green (ICG) is effective in helping doctors identify important lymph nodes during stomach cancer surgery, which can guide more precise and potentially less invasive operations. ^{1 2 3 4 5}

Is indocyanine green (ICG) safe for use in humans?

Indocyanine green (ICG) has been used in various studies for guiding lymph node dissection in gastric and breast cancer surgeries, and while its safety is still being evaluated, it has been used in humans with no major safety concerns reported in the available studies. ^{1 2 5 6 7}

How does the treatment in the Magnetic Lymph Node Mapping for Stomach Cancer trial differ from other treatments for stomach cancer?

This treatment uses indocyanine green (ICG) fluorescence imaging to map lymph nodes, which helps in identifying sentinel nodes (the first nodes to which cancer cells are likely to spread) in stomach cancer. This approach allows for more precise and potentially less invasive surgery compared to traditional methods, as it helps surgeons target only the necessary lymph nodes. ^{1 4 5 8 9}

Research Team

Naruhiko Ikoma, MD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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.

Inclusion Criteria

I am 18 years old or older.

I have been diagnosed with stomach cancer.

Willing to provide informed consent

Exclusion Criteria

I am using birth control during the study.

Allergy or intolerance to iron oxide compounds

I have an iron overload disorder.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Injection

Patients receive FerroTrace peritumorally within days 1-21 before undergoing gastrectomy

3 weeks

Intraoperative Injection

Patients undergo gastrectomy and receive FerroTrace and ICG peritumorally during surgery

During surgery

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• FerroTrace
• Indocyanine Green

Trial Overview 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.

Participant Groups

Group I: Cohort II (intraoperative) Experimental Treatment 3 Interventions

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

Group II: Cohort I (preoperative injection) Experimental Treatment 3 Interventions

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

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Findings from Research

In a study of 80 patients with early gastric cancer, sentinel node (SN) biopsy using indocyanine green (ICG) and (99m)Tc-labeled tin colloid effectively guided individualized surgical procedures, allowing for less extensive surgeries when SNs were negative for metastasis.

The study found a false-negative rate of 23% for frozen section analysis and 7% for postoperative pathology, indicating that while SN biopsy is useful, there is a risk of missing metastasis, particularly in lymph nodes where tracers are distributed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Individualized surgery for early gastric cancer guided by sentinel node biopsy. Ichikura, T., Chochi, K., Sugasawa, H., et al.[2016]

Indocyanine green (ICG) demonstrated a 99% identification rate for sentinel lymph nodes (SLN) in breast cancer patients, which is significantly higher than the 92.8% rate achieved with methylene blue (MB), indicating its superior efficacy as a tracer.

The study, involving 194 patients over a median follow-up of 67 months, found no allergic reactions or permanent skin staining related to ICG, suggesting it is a safe alternative to traditional SLN tracers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short-term and long-term outcomes of indocyanine green for sentinel lymph node biopsy in early-stage breast cancer. Hua, B., Li, Y., Yang, X., et al.[2022]

In a study of 77 patients with early-stage gastric cancer, indocyanine green (ICG) fluorescence imaging demonstrated a high detection rate (94.7%) for sentinel nodes during laparoscopic surgery, comparable to conventional open surgery (94.9%).

The use of ICG fluorescence imaging for sentinel node mapping showed high accuracy (97.2%) and a relatively low false-negative rate (25%) in laparoscopic procedures, suggesting it is a promising method for predicting lymph node metastasis in gastric cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sentinel node mapping guided by indocyanine green fluorescence imaging during laparoscopic surgery in gastric cancer. Tajima, Y., Murakami, M., Yamazaki, K., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Individualized surgery for early gastric cancer guided by sentinel node biopsy. [2016]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Efficacy and safety of indocyanine green tracer-guided lymph node dissection in minimally invasive radical gastrectomy for gastric cancer: A systematic review and meta-analysis. [2022]

3. Italy pubmed.ncbi.nlm.nih.gov

Fluorescence-guided lymphadenectomy in gastric cancer: a prospective western series. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Sentinel node mapping guided by indocyanine green fluorescence imaging in gastric cancer. [2022]

5. Japan pubmed.ncbi.nlm.nih.gov

Assessment of indocyanine green tracer-guided lymphadenectomy in laparoscopic gastrectomy after neoadjuvant chemotherapy for locally advanced gastric cancer: results from a multicenter analysis based on propensity matching. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Short-term and long-term outcomes of indocyanine green for sentinel lymph node biopsy in early-stage breast cancer. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Safety and efficacy of indocyanine green near-infrared fluorescent imaging-guided lymph nodes dissection during radical gastrectomy for gastric cancer: A systematic review and meta-analysis. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Sentinel node mapping guided by indocyanine green fluorescence imaging during laparoscopic surgery in gastric cancer. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Mapping of the perigastric lymphatic network using indocyanine green fluorescence imaging and tissue marking dye in clinically advanced gastric cancer. [2022]