ICG Sentinel Lymph Node Mapping for Vulvar Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
The purpose of this study is to compare two types of imaging for sentinel lymph node (SLN) mapping in people with early-stage vulvar cancer. The researchers will compare indocyanine green near-infrared (ICG-NIR) imaging with lymphoscintigraphy. All participants in this study will be scheduled for standard surgical treatment at Memorial Sloan Kettering Cancer Center (MSK). This surgical treatment includes SLN mapping (with both lymphoscintigraphy and ICG-NIR imaging) and SLN biopsy.
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 indocyanine green (ICG) safe for use in sentinel lymph node mapping?
Indocyanine green (ICG) has been used safely in sentinel lymph node mapping for various cancers, including breast and endometrial cancer, without the risks associated with radioactive tracers. It is generally considered safe, but some patients may experience adverse reactions, so monitoring is important.12345
How is the ICG guided sentinel lymph node biopsy treatment different from other treatments for vulvar cancer?
The ICG guided sentinel lymph node biopsy uses a special dye called indocyanine green (ICG) along with near-infrared light to help doctors find and examine lymph nodes more accurately in vulvar cancer. This method is different from the traditional use of radioactive tracers like 99mtechnetium, offering a potentially safer and more precise alternative for detecting cancer spread.23678
What data supports the effectiveness of the treatment ICG guided sentinel lymph node biopsy for vulvar cancer?
Research shows that using indocyanine green (ICG) with near-infrared fluorescence imaging is effective in mapping sentinel lymph nodes in vulvar cancer, with higher detection rates compared to other dyes. This suggests that ICG is a reliable method for identifying lymph nodes, which is crucial for determining the spread of cancer.23689
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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Preoperative Lymphoscintigraphy
Patients undergo radiocolloid lymphoscintigraphy before surgery; the surgeon is blinded to the results.
Surgical Treatment
Standard surgical treatment including SLN mapping with both lymphoscintigraphy and ICG-NIR imaging, followed by SLN biopsy.
Follow-up
Participants are monitored for safety and effectiveness after surgical treatment.
What Are the Treatments Tested in This Trial?
Interventions
- ICG guided sentinel lymph node biopsy
ICG guided sentinel lymph node biopsy is already approved in European Union, United States, China, India for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Memorial Sloan Kettering Cancer Center
Lead Sponsor