RecruitingOBSERVATIONAL

Indocyanine Green for Detection of Sentinel Lymph Nodes In Comparison to ICG Plus Technetium in the Evaluation of Vulvar Squamous Cell Carcinoma

This study is for women with early vulvar cancer. When vulvar cancer is diagnosed, doctors often check nearby lymph nodes to see if the cancer has spread. They do this by finding the 'sentinel lymph node' – the first node cancer cells would likely go to. Currently, finding this node often involves using two different methods at the same time. This study wants to see if using just one of these methods, a special green dye called Indocyanine Green (ICG) that shows up under a special light, is just as good at finding these nodes as using both methods together. The goal is to make the process simpler and potentially safer for patients.

At a glance

Status

Recruiting

Sponsor

Hamilton Health Sciences Corporation

Enrolment target

Start

01 Oct 2023

Estimated completion

30 Nov 2026

Vulvar Cancer

What is this study about?

When someone has vulvar cancer, doctors often need to check if the cancer has spread to nearby lymph nodes. Lymph nodes are small, bean-shaped glands that are part of your body's immune system. If cancer cells leave the original tumour, they often travel first to a specific lymph node or a small group of nodes nearby. These are called 'sentinel lymph nodes'. Finding and checking these nodes helps doctors decide on the best treatment plan.

Currently, to find these sentinel lymph nodes, doctors often use a 'dual technique'. This usually involves injecting two different substances. One is often a radioactive substance that can be tracked, and the other is a blue or green dye. This study is looking into a newer way that might be simpler: using just one special green dye called Indocyanine Green (ICG).

ICG is a safe dye that lights up when doctors shine a special light on it. The study wants to see if using just this ICG dye by itself is as good and accurate at finding the sentinel lymph nodes as using the current method with two substances. If it is, this could mean a more straightforward and possibly less invasive procedure for women with early vulvar cancer in the future.

Key takeaways

This study evaluates a new way to find sentinel lymph nodes in early vulvar cancer.
It compares a single dye (ICG) to the current method using two substances.
The goal is to simplify the procedure while maintaining accuracy.
It's for adult women with early-stage vulvar squamous cell carcinoma.
Participation involves having the ICG dye method to find lymph nodes.

Who may be eligible?

This study is looking for women aged 18 or older who have been diagnosed with an early stage of vulvar cancer (specifically, a type called vulvar squamous cell carcinoma). Your doctor would need to think that you are a suitable candidate for having your sentinel lymph nodes checked.

To be included, your doctors would need to confirm that the cancer hasn't spread to your groin area based on physical checks or scans, and that your main tumour is a certain size (generally, less than 4 cm). The cancer also needs to have started invading a certain depth (more than 1mm).

However, you wouldn't be able to join this study if you've had radiation treatment in your pelvis, vulva, or groin area before. Also, if you know you're allergic to special dyes like Technetium or ICG, or if your cancer started in a Bartholin gland, you wouldn't be able to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you an adult woman (18 years or older)?
Have you been diagnosed with an early stage of vulvar squamous cell carcinoma?
Has your doctor said you're a candidate for sentinel lymph node testing?
Do you have a clear groin area (no signs of cancer spread there)?
Have you NOT had previous radiation to your pelvic or groin area?
Are you NOT allergic to special dyes like Technetium or ICG?

Answer every question to see your result.

What does participation involve?

The information provided does not give detailed steps on what taking part involves. However, based on the study's aim, if you join, you would likely undergo a procedure to find and remove sentinel lymph nodes. This would involve doctors injecting a special green dye (Indocyanine Green, or ICG) near your vulvar cancer. They would then use a special camera or light to follow the dye and identify the sentinel lymph nodes, which would then be removed for examination.

This procedure usually takes place in a hospital operating room. There would be follow-up appointments after the procedure to check on your recovery and discuss the results. The exact number of visits, duration of follow-up, and total study duration are not specified in the information provided, but your medical team would explain all these details to you.

Potential risks and benefits

Participating in this study might help improve how doctors find sentinel lymph nodes in the future, potentially making the process simpler for other patients. For you directly, there's a chance that using only ICG might be a less complex procedure than the standard approach with two dyes. However, since this is a research study, there's always a small risk that the ICG method might not be as accurate as the current standard, which could affect your diagnostic information. You might also experience minor side effects from the ICG dye, though these are usually rare. You are always free to withdraw from the study at any time, for any reason, without affecting your usual medical care.

Locations (1)

Hamilton Health Sciences
Verified postcode
Hamilton, Canada· Recruiting

Common questions

What are 'sentinel lymph nodes'?

These are the first lymph nodes that cancer cells are most likely to spread to from the original tumour. Checking them helps doctors understand if the cancer has spread.

What is Indocyanine Green (ICG)?

ICG is a special green dye that lights up when a specific type of light is shone on it, allowing doctors to see where it travels in the body.

Why use only ICG instead of two dyes?

Doctors want to see if using just ICG is as effective as the current method, which often uses two different substances. If it is, it could simplify the procedure for patients.

Will taking part in this study change my cancer treatment?

The study aims to evaluate a method for finding sentinel nodes. Your overall cancer treatment plan will still be based on what's best for your specific situation, informed by the results.

What kind of vulvar cancer is this study for?

This study is for early-stage vulvar squamous cell carcinoma, which is a common type of vulvar cancer.

How to find out more

Andra Nica, MD

nica@hhsc.ca 9053879495 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.