What side effects are associated with this type of intervention?

The most common treatments for vulvar cancer include surgery, radiation therapy, and chemotherapy. Surgery, including sentinel lymph node (SLN) mapping and biopsy, can lead to side effects such as pain, infection, lymphedema, and wound complications. Radiation therapy may cause skin irritation, fatigue, and long-term effects like fibrosis and secondary malignancies. Chemotherapy can result in nausea, vomiting, hair loss, and increased risk of infection. Specifically, for treatments involving ICG-NIR imaging, side effects are generally minimal but can include allergic reactions to the dye and mild discomfort at the injection site.

What prior FDA approvals exist?

There is limited specific information on prior FDA approvals for treatments using Indocyanine Green Near-Infrared (ICG-NIR) Imaging for vulvar cancer. However, standard treatments for vulvar cancer typically include surgery, radiation therapy, and chemotherapy. Sentinel lymph node mapping, which can involve the use of imaging techniques like lymphoscintigraphy, is a common procedure to guide surgical treatment. The use of ICG-NIR imaging is being studied as a potential method to improve the accuracy of sentinel lymph node detection in vulvar cancer.

What other types of research exist?

Promising novel alternatives to Indocyanine Green Near-Infrared (ICG-NIR) Imaging for vulvar cancer patients include: 1) Sentinel lymph node mapping using advanced radiotracers such as 68Ga-PSMA PET/CT, which has shown high accuracy in other cancers like prostate cancer. 2) Molecular imaging techniques, such as those utilizing specific tumor markers or genetic profiling, which can provide more precise localization and characterization of cancerous tissues. 3) Enhanced fluorescence imaging agents that target specific cancer cell receptors, potentially offering higher specificity and sensitivity compared to ICG.

← Back to Search

Procedure

ICG Sentinel Lymph Node Mapping for Vulvar Cancer

N/A

Recruiting

Led By Vance Broach, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

≥18 years of age

Primary tumor ≤4 cm in size

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 18 months

Awards & highlights

Study Summary

This trial is studying two methods of mapping sentinel lymph nodes for early-stage vulvar cancer before surgery at MSK. Both imaging methods and biopsy of the found nodes will be done.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Potential side effects are not specified in the provided information but may include typical risks associated with diagnostic imaging agents like allergic reactions or discomfort at the injection site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Select...

My primary tumor is 4 cm or smaller.

Select...

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

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

success of identifying the SLN

Trial Design

1Treatment groups

Experimental Treatment

Group I: patients undergoing preoperative lymphoscintigraphyExperimental Treatment1 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.

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Indocyanine Green Near-Infrared (ICG-NIR) Imaging is a technique used in the treatment of vulvar cancer that involves injecting a fluorescent dye, indocyanine green, which binds to proteins and is visualized using near-infrared light. This method is particularly useful for sentinel lymph node mapping, allowing for precise identification of the first lymph node(s) that cancer cells are likely to spread to from the primary tumor. By accurately identifying and removing these nodes, this technique helps prevent the spread of cancer and reduces the need for more extensive lymph node removal, thereby minimizing complications and improving patient outcomes.

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,942 Previous Clinical Trials

588,958 Total Patients Enrolled

Vance Broach, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

1 Previous Clinical Trials

23 Total Patients Enrolled

~27 spots leftby Nov 2026

Unbiased ResultsWe believe in providing patients with all the options.

Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.

Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.