ICG Sentinel Lymph Node Mapping for Vulvar Cancer

Not currently recruiting at 7 trial locations

Overseen By Mario Leitao, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Enlarged lymph nodes, Metastases, 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: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two imaging methods to locate lymph nodes in patients with early-stage vulvar cancer. Researchers will test indocyanine green near-infrared (ICG-NIR) imaging against lymphoscintigraphy to determine which is more effective. Participants will undergo standard surgery, using both imaging methods to guide lymph node removal. Individuals newly diagnosed with vulvar cancer, especially those with tumors 4 cm or smaller, may be eligible to join. As an unphased trial, this study allows participants to contribute to research that could enhance imaging techniques for future patients.

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 these imaging techniques are safe for sentinel lymph node mapping in vulvar cancer?

Research has shown that using indocyanine green (ICG) to find sentinel lymph nodes (SLN) is safe for women with vulvar cancer. Studies indicate that ICG is as effective as current methods without adding extra risks. Reports have not identified any serious side effects, suggesting it is well-tolerated. The procedure is practical and effective, showing potential for improved detection rates. Therefore, ICG appears to be a safe choice for SLN mapping in vulvar cancer cases. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about ICG guided sentinel lymph node biopsy for vulvar cancer because it offers a new way to identify cancer spread with precision. Unlike traditional methods that use radiocolloid lymphoscintigraphy, this technique relies on an injection of indocyanine green (ICG) and near-infrared imaging to visually guide surgeons in locating lymph nodes. This approach could improve accuracy in detecting sentinel lymph nodes, potentially leading to more effective surgeries and better outcomes for patients.

What evidence suggests that ICG-NIR imaging is effective for sentinel lymph node mapping in vulvar cancer?

Studies have shown that indocyanine green (ICG) effectively identifies sentinel lymph nodes (SLNs) in vulvar cancer. Research indicates that ICG matches the effectiveness of traditional radiotracer methods, offering a safe alternative. In this trial, patients will undergo preoperative lymphoscintigraphy, and the surgeon will inject ICG according to the SLN protocol during surgery. Patients who used ICG with near-infrared imaging during surgeries achieved successful results. This method is known for its accuracy and favorable outcomes in identifying SLNs. However, it may not provide additional benefits for certain cases, such as those with midline lesions. Overall, ICG presents a promising option for SLN mapping in vulvar cancer. ^{3 6 7 8 9}

Who Is on the Research Team?

Vance Broach, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 with early-stage vulvar cancer, scheduled for sentinel lymph node biopsy at MSK. It includes those with tumors up to 4 cm and squamous cell carcinoma patients must have more than 1 mm of invasion.

Inclusion Criteria

My primary tumor is 4 cm or smaller.

My squamous cell carcinoma has invaded more than 1 mm deep.

I have recently been diagnosed with vulvar cancer and will have a sentinel lymph node biopsy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Lymphoscintigraphy

Patients undergo radiocolloid lymphoscintigraphy before surgery; the surgeon is blinded to the results.

1 week

1 visit (in-person)

Surgical Treatment

Standard surgical treatment including SLN mapping with both lymphoscintigraphy and ICG-NIR imaging, followed by SLN biopsy.

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after surgical treatment.

18 months

What Are the Treatments Tested in This Trial?

Interventions

• ICG guided sentinel lymph node biopsy

Trial Overview

The study compares two imaging techniques for mapping sentinel lymph nodes in vulvar cancer: indocyanine green near-infrared (ICG-NIR) imaging versus traditional lymphoscintigraphy, during standard surgical treatment.

How Is the Trial Designed?

Group I: patients undergoing preoperative lymphoscintigraphy Experimental Treatment 1 Intervention

Patients will undergo radiocolloid lymphoscintigraphy before their surgery; the surgeon will be blinded to the results of this procedure. The surgeon will subsequently inject ICG in accordance with the SLN protocol in the operating room and will identify and remove the SLN by use of near-infrared imaging guidance only.

ICG guided sentinel lymph node biopsy is already approved in European Union, United States, China, India for the following indications:

Approved in European Union as Indocyanine Green for:

• Diagnostic imaging agent for sentinel lymph node detection in breast cancer

Approved in United States as Indocyanine Green for:

• Diagnostic imaging agent for sentinel lymph node detection in breast cancer

Approved in China as Indocyanine Green for:

• Diagnostic imaging agent for sentinel lymph node detection in breast cancer

Approved in India as Indocyanine Green for:

• Diagnostic imaging agent for sentinel lymph node detection in breast cancer

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Published Research Related to This Trial

In a study of 30 patients with early vulvar cancer, indocyanine green (ICG) demonstrated a sensitivity of 80.8% and a positive predictive value (PPV) of 96.2% for detecting sentinel lymph nodes (SLN), indicating it is effective but not as reliable as the gold standard 99mTc-nanocolloids.

ICG showed a slightly higher sensitivity of 82.3% for detecting infiltrated SLN compared to 99mTc-nanocolloids, but due to a false negative rate of 19.1%, it is recommended to use ICG in combination with 99mTc-nanocolloids for optimal SLN detection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Performance of Indocyanine Green Compared to 99mTc-Nanocolloids for Sentinel Lymph Node Detection in Early Vulvar Cancer. Benmoulay-Rigollot, C., Karpathiou, G., Prevot-Bitot, N., et al.[2023]

The use of indocyanine green (ICG) as a fluorescent tracer for sentinel lymph node biopsy (SLNB) in breast cancer patients resulted in a 100% sensitivity rate for detecting sentinel lymph nodes, demonstrating its effectiveness.

This study, involving 184 patients, confirms that ICG is a safe alternative to traditional radioisotope methods, reducing risks associated with radioactivity and potentially lowering costs and resource use in the surgical process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of indocyanine green as the only tracer for the identification of the sentinel lymph node in breast cancer: safety and feasibility. Pellini, F., Bertoldi, L., Deguidi, G., et al.[2022]

This study reports the successful use of indocyanine green (ICG) for sentinel lymph node (SLN) mapping in a patient with vaginal cancer, marking a first in this application.

The SLN mapping was effective, with no lymph node metastasis found, indicating that ICG can be a reliable method for identifying lymph nodes in vaginal cancer surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sentinel lymph node mapping with indocyanine green in vaginal cancer. Lee, IO., Lee, JY., Kim, S., et al.[2018]

Indocyanine green (ICG) combined with near-infrared (NIR) fluorescence imaging shows a high sentinel lymph node (SLN) detection rate in vulvar cancer, ranging from 89.7% to 100%, making it a promising alternative to traditional techniques.

The use of ICG for SLN mapping appears to be safe, with no reported adverse events, but further large-scale studies are needed to standardize the technique and fully assess its effectiveness compared to existing methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnostic value of indocyanine green fluorescence guided sentinel lymph node biopsy in vulvar cancer: A systematic review. Koual, M., Benoit, L., Nguyen-Xuan, HT., et al.[2021]

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]

Robotic sentinel lymph node (SLN) mapping using indocyanine green (ICG) was successfully performed in a 75-year-old woman with vulvar cancer, showing no intraoperative or postoperative complications, which highlights its safety and feasibility.

The procedure provided reliable staging information, as the pathology report indicated positive SLN, suggesting that ICG could be an effective alternative to other tracers, although further studies are needed to confirm its advantages.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robotic video endoscopic inguinal lymphadenectomy (R-VEIL) for vulvar cancer with sentinel node mapping using indocyanine green and near-infrared fluorescence imaging technology. Naldini, A., Vizzielli, G., Perrone, E., et al.[2018]

Planar lymphoscintigraphy (PL) and indocyanine green (ICG) fluorescence are the most effective techniques for identifying sentinel lymph nodes (SLN) in early vulvar cancer, with detection rates of 96.13% and 91.90% respectively, compared to blue dye which had a lower detection rate of 90.44%.

The average number of SLNs detected was higher with PL (2.61 nodes) compared to ICG (1.78 nodes), but both techniques showed no significant statistical difference in the number of nodes detected, suggesting they are both reliable methods for SLN identification.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Detection of sentinel lymph node in vulvar cancer using 99mTc-labeled colloid lymphoscintigraphy, blue dye, and indocyanine-green fluorescence: a meta-analysis of studies published in 2010-2020. Di Donna, MC., Quartuccio, N., Giallombardo, V., et al.[2023]

The study involving 12 women with stage I vulvar cancer demonstrated that using the ICG-99mTc-nanocolloid tracer for sentinel lymph node (SLN) mapping is highly effective, achieving a 100% detection rate of SLNs during surgery.

This dual-modality approach not only allows for real-time imaging but also reduces the required dose of ICG by five times compared to other formulations, enhancing safety and convenience for preoperative administration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sentinel Lymph Node Biopsy in Vulvar Cancer Using Combined Radioactive and Fluorescence Guidance. Verbeek, FP., Tummers, QR., Rietbergen, DD., 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]

Citations

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This video demonstrates a successful ICG fluorescence image-guided left inguinal SLN biopsy in a vulvar cancer patient using a laparoscopic camera.

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This study demonstrated the use of ICG was a safe method with similar detection rates with radiotracer. With no benefits in patients with midline lesions, ...

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12026259/

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Sentinel lymph node biopsy (SLNB), in selected cases, has emerged as a less invasive alternative with favorable oncologic outcomes. Objective: ...

6.

pubmed.ncbi.nlm.nih.gov

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ICG for SLN mapping appears to be safe in women with vulvar cancer with a detection rate similar to the current techniques.

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sciencedirect.com

sciencedirect.com/science/article/pii/S0090825821000913#!

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The primary outcome was to determine if the use of ICG alone in detecting SLN in women with vulvar cancer is as accurate as the gold standard dual labeling ...

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onlinelibrary.wiley.com

onlinelibrary.wiley.com/doi/full/10.1002/wjo2.197

Indocyanine green fluorescence‐guided sentinel lymph ...

ICG-guided SLNB procedures are feasible and effective in the context of HNCs. The technique offers potentially higher SLN detection rates and shows promise.

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international-journal-of-gynecological-cancer.com

international-journal-of-gynecological-cancer.com/article/S1048-891X(24)08968-0/fulltext

Sentinel Lymph Node Biopsy in the Management of Vulvar ...

Patients with a small unifocal primary tumor (<4 cm) and no obvious preoperative metastasis have been shown to have low groin recurrence rates and excellent ...