ICG Guided Sentinel Lymph Node Mapping for Pediatric Solid Tumors

Overseen By Andrew J. Murphy, MD

Age: < 65

Sex: Any

Trial Phase: Phase < 1

Sponsor: St. Jude Children's Research Hospital

Disqualifiers: Iodide allergies, Pregnancy, Extensive prior surgery, others

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

15 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of the study is to find out the usefulness and safety of a dye called Indocyanine Green (ICG for short). This dye will be used to help the surgeon find lymph nodes draining solid tumors inside the abdomen that need to be removed. This may also help the surgeon to find if the cancer has moved to other lymph nodes outside of the known area. Primary Objectives * To determine the percentage of patients in whom Indocyanine Green (ICG)-guided sentinel lymph node (SLN) mapping was successful at the time of retroperitoneal lymph node dissection for staging of visceral solid tumors. * To determine the percentage of patients with grade 3 or higher adverse events related to ICG use.

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 Indocyanine Green (ICG) for sentinel lymph node mapping in pediatric solid tumors?

Research shows that using Indocyanine Green (ICG) for sentinel lymph node mapping in adults has a high detection rate, with up to 97% sensitivity, which is better than the traditional blue dye method. This suggests that ICG could also be effective for detecting sentinel lymph nodes in pediatric patients with solid tumors. ^{1 2 3 4 5}

Is Indocyanine Green (ICG) safe for use in humans?

Indocyanine Green (ICG) has been shown to be a safe method for detecting sentinel lymph nodes in adults, with higher sensitivity compared to traditional blue dye. While specific safety data for pediatric use is limited, ICG is used in various cancer procedures and is generally considered safe. ^{4 6 7 8 9}

How is the drug Indocyanine Green (ICG) used in sentinel lymph node mapping for pediatric solid tumors different from other treatments?

Indocyanine Green (ICG) is unique because it uses fluorescence imaging to help identify sentinel lymph nodes, which can guide more precise and less invasive surgeries. This method is different from traditional techniques as it allows for real-time visualization during surgery, potentially improving accuracy and reducing the need for extensive lymph node removal. ^{1 3 5 10 11}

Research Team

Andrew Davidoff, MD

Principal Investigator

St. Jude Children's Research Hospital

Eligibility Criteria

This trial is for patients under 21 with pediatric solid tumors in the abdomen needing lymph node removal. They must be able to consent (or their guardian) and not be pregnant, have had extensive prior surgery at the tumor site, or have iodide allergies.

Inclusion Criteria

I am under 21 with a solid tumor needing lymph node surgery in my abdomen.

Exclusion Criteria

Pregnant female

Subjects with a history of iodide allergies

I am unable or unwilling to sign the consent form for this study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Participants receive Indocyanine Green intraoperatively to guide sentinel lymph node mapping

1 day

1 visit (in-person)

Immediate Follow-up

Participants are monitored for adverse events related to ICG use for 24 hours post-surgery

1 day

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Indocyanine Green

Trial Overview The study tests Indocyanine Green (ICG), a dye used during surgery to identify lymph nodes affected by abdominal solid tumors. The goal is to see how well ICG helps in mapping these nodes and if it's safe.

Participant Groups

Group I: Indocyanine green (ICG) Experimental Treatment 1 Intervention

Participants will receive Indocyanine green intraoperatively.

Indocyanine Green is already approved in United States, European Union, China, Japan for the following indications:

Approved in United States as Indocyanine Green for:

• Diagnostic imaging agent for various medical procedures including sentinel lymph node mapping

Approved in European Union as Indocyanine Green for:

• Diagnostic imaging agent for various medical procedures including sentinel lymph node mapping

Approved in China as Indocyanine Green for:

• Diagnostic imaging agent for various medical procedures including sentinel lymph node mapping, liver function testing

Approved in Japan as Indocyanine Green for:

• Diagnostic imaging agent for various medical procedures including sentinel lymph node mapping, liver function testing

Who Is Running the Clinical Trial?

St. Jude Children's Research Hospital

Lead Sponsor

Trials

451

Recruited

5,326,000+

Findings from Research

Indocyanine green (ICG) was successfully used to detect sentinel lymph nodes in 150 out of 153 breast cancer patients, demonstrating a high sensitivity of 98.0%, which is better than traditional methods like radioisotope detection.

The specificity of ICG for sentinel lymph node detection was 100%, suggesting it is a highly reliable method, and the authors recommend its inclusion as a primary or alternative technique in clinical guidelines for breast cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Indocyanine green in diagnostics and reconstructive surgery for breast cancer]. Zikiryakhodzhaev, AD., Starkov, MV., Timoshkin, VO.[2023]

The study demonstrated that indocyanine green (ICG) fluorescence imaging is effective for sentinel node (SN) mapping in gastrointestinal cancers, achieving high detection rates of 90.9% for gastric cancer and 88.5% for colorectal cancer among 48 patients.

ICG fluorescence imaging provided real-time visualization of lymphatic vessels and SNs, with promising accuracy rates, particularly showing 100% accuracy in T(1) stage colorectal cancer, indicating its potential as a valuable tool for surgical navigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sentinel node mapping guided by indocyanine green fluorescence imaging: a new method for sentinel node navigation surgery in gastrointestinal cancer. Kusano, M., Tajima, Y., Yamazaki, K., et al.[2021]

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]

The addition of indocyanine green (ICG) to the standard sentinel lymph node procedure in 15 pediatric patients significantly improved detection rates, with 95% of sentinel lymph nodes being fluorescent and 100% radioactive, compared to only 60% staining with blue dye.

ICG-TC was found to be a safe and effective method for visual detection of sentinel lymph nodes, leading to the identification of six additional nodes and no reported adverse events during the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sentinel Lymph Node Procedure in Pediatric Patients with Melanoma, Squamous Cell Carcinoma, or Sarcoma Using Near-Infrared Fluorescence Imaging with Indocyanine Green: A Feasibility Trial. Jeremiasse, B., van Scheltinga, CEJT., Smeele, LE., et al.[2023]

In a multicenter feasibility study involving 22 patients with early-stage oropharyngeal, hypopharyngeal, or supraglottic cancer, the combination of transoral surgery and indocyanine green sentinel node navigation surgery (ICG-SNNS) achieved a 100% identification rate of sentinel nodes, indicating high effectiveness in locating lymph nodes during surgery.

The study reported favorable oncological outcomes, including a 5-year disease-specific survival rate of 100% and an overall survival rate of 72.3%, suggesting that this minimally invasive approach is not only feasible but also effective in managing these types of cancers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Minimally invasive surgery for laryngopharyngeal cancer: Multicenter feasibility study of a combination strategy involving transoral surgery and real-time indocyanine green fluorescence-navigated sentinel node navigation surgery. Araki, K., Tomifuji, M., Shiotani, A., et al.[2021]

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 1414 patients undergoing sentinel lymph node biopsy for endometrial cancer, there were no reported anaphylactic reactions to indocyanine green (ICG), even among those with a history of iodine or contrast allergies.

The incidence of adverse reactions was low, with only 3 patients experiencing potentially allergic reactions, suggesting that ICG is safe for use in this context, especially when premedication with corticosteroids is applied.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sentinel lymph node biopsy in patients with endometrial cancer and an indocyanine green or iodinated contrast reaction - A proposed management algorithm. Zammarrelli, WA., Afonso, AM., Broach, V., et al.[2022]

A survey of 75 French surgeons revealed that 37% have been using indocyanine green (ICG) for sentinel lymph node detection in breast cancer for 2 to 3 years, indicating growing acceptance of this technique.

The main advantage of ICG is its ability to reduce organizational constraints in procedures, but challenges include the need for specialized near-infrared camera equipment and a lack of formal validation in French guidelines, highlighting the need for further studies and standardization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical use of Indocyanine green fluorescence method for sentinel lymph node biopsy in breast cancer in France in 2021. Benoit, L., de Thorey, AG., David, MG., et al.[2023]

Indocyanine green (ICG) demonstrated a sensitivity of 87% for detecting sentinel lymph nodes, making it more effective than blue dye, which had a sensitivity of only 44%.

ICG is a safe and effective alternative to blue dye in sentinel lymph node biopsies, potentially reducing the need for lymphoscintigraphy and minimizing anesthesia time for pediatric patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fluorescent-guided surgery and the use of indocyanine green sentinel lymph node mapping in the pediatric and young adult oncology population. Johnston, ME., Farooqui, ZA., Nagarajan, R., et al.[2023]

In a clinical trial involving 169 patients, the combination of indocyanine green (ICG) and blue dye for sentinel lymph node (SLN) mapping resulted in a detection rate of 96.9% and a significantly lower false-negative rate of 3.4%, compared to 84.9% detection and 11.1% false-negative rate with blue dye alone.

The study demonstrated that using ICG in combination with blue dye not only improved the accuracy of SLN detection but also enhanced the prediction of axillary lymph node status in breast cancer patients, making it a more effective method for surgical planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of Fluorescence Imaging in Combination with Patent Blue Dye versus Patent Blue Dye Alone in Sentinel Lymph Node Biopsy in Breast Cancer. Tong, M., Guo, W., Gao, W.[2021]

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. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Indocyanine green in diagnostics and reconstructive surgery for breast cancer]. [2023]

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

Sentinel node mapping guided by indocyanine green fluorescence imaging: a new method for sentinel node navigation surgery in gastrointestinal cancer. [2021]

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

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

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

Sentinel Lymph Node Procedure in Pediatric Patients with Melanoma, Squamous Cell Carcinoma, or Sarcoma Using Near-Infrared Fluorescence Imaging with Indocyanine Green: A Feasibility Trial. [2023]

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

Minimally invasive surgery for laryngopharyngeal cancer: Multicenter feasibility study of a combination strategy involving transoral surgery and real-time indocyanine green fluorescence-navigated sentinel node navigation surgery. [2021]

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

Sentinel lymph node biopsy in patients with endometrial cancer and an indocyanine green or iodinated contrast reaction - A proposed management algorithm. [2022]

8. France pubmed.ncbi.nlm.nih.gov

Clinical use of Indocyanine green fluorescence method for sentinel lymph node biopsy in breast cancer in France in 2021. [2023]

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

Fluorescent-guided surgery and the use of indocyanine green sentinel lymph node mapping in the pediatric and young adult oncology population. [2023]

10. Korea (South) pubmed.ncbi.nlm.nih.gov

Use of Fluorescence Imaging in Combination with Patent Blue Dye versus Patent Blue Dye Alone in Sentinel Lymph Node Biopsy in Breast Cancer. [2021]

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

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