ICG Guided Sentinel Lymph Node Mapping for Pediatric Solid Tumors

Recruiting at 2 trial locations

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

25 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a special dye called Indocyanine Green (ICG) to help surgeons locate lymph nodes linked to abdominal tumors in children and teens. The main goal is to determine how effectively the dye identifies lymph nodes that may contain cancer. The trial also monitors for any serious side effects from using the dye. Children and teens under 21 with certain suspected tumors, such as Wilms tumor or para-testicular rhabdomyosarcoma, who require lymph node removal, might be suitable candidates. As an Early Phase 1 trial, this research focuses on understanding how the dye works in people, offering participants a chance to be among the first to benefit from this innovative approach.

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 prior data suggests that Indocyanine Green (ICG) is safe for pediatric solid tumor procedures?

Research has shown that Indocyanine Green (ICG) is safe for use in medical settings. Studies have found that patients, including children, experienced no negative reactions or problems from ICG, indicating it is well-tolerated when assisting surgeons in locating lymph nodes during surgeries.

One study specifically found that a dose of 1.5 mg/kg of ICG was safe for children treated for various types of cancer. Another report demonstrated that ICG is both effective and safe for locating lymph nodes and protecting kidney function during surgery.

Overall, the evidence suggests that ICG is a safe choice for these medical procedures. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for pediatric solid tumors rely on traditional imaging or surgical techniques to locate sentinel lymph nodes, which can be challenging and less precise. However, Indocyanine Green (ICG) makes this process different by using a fluorescent dye to guide surgeons more accurately during operations. Researchers are excited because ICG can potentially enhance the precision of sentinel lymph node mapping, leading to better outcomes with fewer complications. This method offers a promising new approach that could improve surgical success and recovery for young patients with solid tumors.

What evidence suggests that Indocyanine Green (ICG) is effective for sentinel lymph node mapping in pediatric solid tumors?

Research has shown that Indocyanine Green (ICG), administered intraoperatively in this trial, can help surgeons identify lymph nodes for removal during surgery for solid tumors. In studies with children, ICG successfully identified sentinel lymph nodes, the first nodes where cancer is likely to spread. This method has shown promise in enhancing surgical effectiveness by locating tumors and small growths that might otherwise remain unseen. Additionally, ICG has proven safe during these procedures. These findings suggest that ICG could be a valuable tool in surgeries for solid tumors in children. ^{1 5 6 7 8}

Who Is on the Research Team?

Andrew Davidoff, MD

Principal Investigator

St. Jude Children's Research Hospital

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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 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]

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 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]

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]

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) 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]

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]

Citations

1. nature.com nature.com/articles/s41598-024-80543-7

Sentinel lymph node mapping with Indocyanine green ... A prospective observational study focused on pediatric and adolescent patients undergoing SLNB using ICG-NIR at a single institution from 2019 to 2022.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05645523

Indocyanine Green (ICG) Guided Sentinel Lymph Node ... To determine the percentage of patients in whom Indocyanine Green (ICG)-guided sentinel lymph node (SLN) mapping was successful at the time of retroperitoneal ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39627247/

Sentinel lymph node mapping with Indocyanine green ... A prospective observational study focused on pediatric and adolescent patients undergoing SLNB using ICG-NIR at a single institution from 2019 to 2022.

4. cancer.gov cancer.gov/clinicaltrials/NCI-2025-07397

Indocyanine Green to Guide Sentinel Lymph Node ... This may be a safe and effective way to guide sentinel lymph node mapping in pediatric solid tumor patients undergoing lymph node dissection. Eligibility ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12026291/

Advancing Pediatric Surgery with Indocyanine Green (ICG) ... showed that ICG was useful in locating tumors, determining surgical margins, and identifying small lesions that may not be visible on ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S1055858624000052

Indocyanine green (ICG) fluorescence-enhanced ... ICG-fluorescence guided surgery is poised to address the challenges of pediatric and neonatal operations for a growing breadth of surgical pathology.

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37543553/

Identification of Pediatric Tumors Intraoperatively Using ... Overall, ICG appeared effective and safe for lymph node sampling and nephron-sparing procedures. Conclusions: Despite promising results from FGS ...

8. frontiersin.org frontiersin.org/journals/pediatrics/articles/10.3389/fped.2021.689612/full

Indocyanine Green–Guided Pediatric Tumor Resection We show that an ICG dose of 1.5 mg/kg is safe in pediatric patients receiving therapy for different types of malignancies. By using the study ...