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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a magnetic tracer called FerroTrace and a fluorescent dye called Indocyanine Green (ICG) can help doctors locate lymph nodes affected by stomach cancer during surgery. Researchers seek to improve disease detection in patients undergoing stomach removal surgery. The trial is recruiting participants diagnosed with a specific type of stomach cancer who are scheduled for surgery. Participants should not have cancer that has spread to other parts of the body. As a Phase 1 trial, the research focuses on understanding how this new treatment works in people, offering participants the opportunity to be among the first to receive it.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research is investigating how well the combination of FerroTrace and a glowing dye called indocyanine green (ICG) can identify lymph nodes affected by stomach cancer. FerroTrace has undergone testing in large animals, but limited information exists about its safety in humans. Therefore, monitoring for any side effects is crucial.

Indocyanine green, however, has been studied more extensively. Research has shown that ICG is generally safe and effective in surgeries, helping doctors see cancer more clearly. One study that reviewed many others found that using ICG during stomach cancer surgery is both safe and useful.

As this is an early-phase study, the primary goal is to assess the safety and tolerability of these treatments in people. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the potential of FerroTrace and Indocyanine Green (ICG) for stomach cancer because these agents offer a new way to visualize and map lymph nodes during surgery. Unlike traditional methods that rely on visual inspection and palpation, FerroTrace uses magnetic properties for precise detection, which could lead to more accurate removal of cancerous tissue. ICG, on the other hand, is a fluorescent dye that helps surgeons see lymphatic structures in real-time. Together, these innovations might improve surgical outcomes by ensuring more thorough cancer removal while minimizing harm to healthy tissue.

What evidence suggests that this trial's treatments could be effective for stomach cancer?

Research shows that using FerroTrace with indocyanine green (ICG) may help doctors identify lymph nodes affected by stomach cancer. In this trial, participants in Cohort I will receive a preoperative injection of FerroTrace, followed by ICG during surgery. Participants in Cohort II will receive both FerroTrace and ICG intraoperatively. Animal studies have demonstrated that this combination improves the detection of these nodes, which are crucial for understanding cancer spread. Surgeons have used ICG to highlight lymph nodes during surgery, aiding in the more effective removal of cancerous tissue. This method has led to better surgical outcomes by helping locate more nodes. FerroTrace, a magnetic tracer, is still under study, but early results suggest it could enhance node detection. Together, these treatments offer hope for more precise cancer surgeries. ^{1 4 6 7 8}

Who Is on the Research Team?

Naruhiko Ikoma, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

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 have been diagnosed with stomach cancer.

Willing to provide informed consent

I have gastric cancer confirmed by biopsy and am having surgery to remove it.

Exclusion Criteria

I am using birth control during the study.

I have an iron overload disorder.

Allergy or intolerance to iron oxide compounds

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10338612/

Preclinical evaluation of sentinel node localization in the ... In this study, the combination of FerroTrace and ICG is applied to a large animal stomach model in order to determine the efficacy of this dual ...

2. withpower.com withpower.com/trial/phase-1-adenocarcinoma-7-2021-e1e6e

Magnetic Lymph Node Mapping for Stomach Cancer 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 ...

3. aijourn.com aijourn.com/ferronova-nanoparticle-trial-begins-in-patients-with-gastric-and-oesophageal-cancers/

Ferronova - Nanoparticle Trial Begins in Patients With ... Where the cancer has also spread to lymph nodes, the 5-year relative survival is only 34.6% and 27.7% [1][2]. Ferronova's FerroTrace® product is ...

4. researchgate.net researchgate.net/publication/370655293_Preclinical_evaluation_of_sentinel_node_localization_in_the_stomach_via_mannose-labelled_magnetic_nanoparticles_and_indocyanine_green

(PDF) Preclinical evaluation of sentinel node localization in ... SLN localization in gastric cancer prognosis and treatment. While SLNB concepts, such as the conservative 'pick-up'. method of lymphadenectomy ...

5. anzctr.org.au anzctr.org.au/Trial/Registration/TrialReview.aspx?id=381979&isReview=true

ANZCTR - Registration The study will also investigate the feasibility of assessing lymph nodes for metastasis using FerroTrace enhanced MRI in rectal cancer subjects and in colon ...

6. 1stoncology.com 1stoncology.com/blog/ferronova-nanoparticle-trial-begins-in-patients-with-gastricoesophageal-cancers1234641961/

Ferronova – Nanoparticle Trial Begins in Patients With Gastric ... On April 9, 2024 Ferronova reported the initiation of a clinical trial of the company's FerroTrace nanoparticle technology in patients with gastric and ...

7. researchgate.net researchgate.net/publication/388578705_Evaluating_the_Role_of_Robotic_Surgery_Gastric_Cancer_Treatment_A_Comprehensive_Review_by_the_Robotic_Global_Surgical_Society_TROGSS_and_European_Federation_International_Society_for_Digestive_Surgery

Evaluating the Role of Robotic Surgery Gastric Cancer ... Key outcomes, including operative time, intraoperative blood loss, lymph node retrieval, postoperative complications, learning curve duration, ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10512638/

Functional roles of magnetic nanoparticles for the ... This review focuses on the feasibility and current application status of MNPs for imaging metastatic nodules in preclinical and clinical development.