Ongoing, recruitingPhase III and phase IV (Integrated)Interventional

The bilateral sentinel node detection rate of fluorescent indocyanine green compared to 99mTc and blue dye in the sentinel node procedure in stage I-IIA cervical cancer

This research is looking at better ways to find specific lymph nodes, called 'sentinel lymph nodes', in women who have early-stage cervical cancer. These are the first lymph nodes cancer cells might spread to from a tumour. The study compares a newer method using a fluorescent dye called indocyanine green with older, more established methods involving a special radioactive dye and a blue dye. We want to see which method is most effective at identifying these nodes on both sides of the body. Finding these nodes accurately helps doctors decide the best treatment plan. It's a key step in understanding if the cancer has started to spread beyond the cervix.

At a glance

Status

Ongoing, recruiting

Phase

Phase III and phase IV (Integrated)

Sponsor

Universitair Medisch Centrum Utrecht

Enrolment target

101

Start

10 May 2024

cervical cancer stage I-IIA

What is this study about?

This study is designed to help doctors find a particular type of lymph node called a 'sentinel lymph node' in women with early-stage cervical cancer. Imagine your body's lymphatic system as a network of roads, and lymph nodes are like rest stops along these roads. When cancer cells might spread, they usually travel to the very first rest stop in that area; these are the sentinel lymph nodes. If these first nodes are clear of cancer, it's a good sign that the cancer hasn't spread further.

Currently, doctors often use a mild radioactive dye and/or a blue dye to help find these nodes during surgery. This study is comparing these traditional methods with a newer method that uses a special fluorescent dye called indocyanine green (often shortened to ICG). This dye lights up under a special camera. The main goal is to see which method is better at consistently finding at least one sentinel lymph node on both sides of the pelvis, as cervical cancer can affect either side.

Ultimately, researchers hope to find the most accurate and reliable way to identify these crucial lymph nodes. By doing so, doctors can make more informed decisions about treatment, potentially helping women with cervical cancer get the most appropriate care with the fewest side effects.

Key takeaways

This study compares methods for finding 'sentinel lymph nodes' in early cervical cancer.
It tests a fluorescent dye (ICG) against traditional radioactive and blue dyes.
The main aim is to see which method best finds nodes on both sides of the body.
Finding these nodes helps doctors tailor the best possible treatment.
Participants are adult women with Stage I or IIA cervical cancer.
Participation involves using the new dye during your planned surgery.

Who may be eligible?

This study is looking for women diagnosed with early-stage cervical cancer. This means the cancer is either Stage I or Stage IIA. Doctors use these stages to describe how much the cancer has grown and if it has spread.

To join, you must be at least 18 years old. There's no upper age limit, meaning women of any adult age who meet the other criteria can be considered.

Basically, if you're an adult woman with cervical cancer that's considered to be in its early stages (Stage I or IIA), you might be able to take part in this research.

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.

I am an adult (18 years or older).
I am female.
I have been diagnosed with cervical cancer.
My cervical cancer is considered early stage (Stage I or IIA).

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will undergo a procedure where doctors try to find your sentinel lymph nodes. This procedure is part of your planned surgery for cervical cancer. Instead of just using the usual methods, they will also use the new fluorescent dye (ICG).

Before your surgery, new scans might be taken to help locate the nodes. During your operation, doctors will use different techniques to identify the sentinel lymph nodes, including the ICG dye that glows under a special light, a radioactive dye, and a blue dye. They will note how many nodes are found by each method and where they are located. They'll also record how long it takes to find these nodes using the different dyes.

After your surgery, you will be asked to complete two questionnaires: one about your experience with your cancer care and the procedure, and another for the surgeons to give their feedback on the new imaging technique. The total duration of your participation will depend on your hospital stay and follow-up appointments.

Potential risks and benefits

Participating in this study might offer a small benefit by potentially helping to ensure the most effective method is used to find your sentinel lymph nodes, which could lead to more precise treatment. However, the exact benefit to you personally is not guaranteed, as the study aims to compare methods. There are potential risks associated with any medical procedure, including those related to the dyes used. The radioactive dye involves a small amount of radiation, and both the blue dye and ICG can have rare side effects, such as allergic reactions. The research team will explain all known risks to you in detail. Remember, choosing to participate is completely voluntary, and you are free to withdraw from the study at any time without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Netherlands

Common questions

What is a 'sentinel lymph node'?

It's the very first lymph node a cancer might spread to from a tumour. Finding it helps doctors see if the cancer has started to spread.

Why are you comparing different dyes?

We want to find out which dye or method is best at accurately finding these important lymph nodes on both sides of the body.

Will this change my cancer treatment?

The goal is to improve how doctors find nodes, which can then help them plan the most effective treatment for you.

What is ICG?

ICG is Indocyanine Green, a special fluorescent dye that lights up under a specific camera, helping doctors spot the nodes.

Is this a new type of operation?

No, this study is about comparing tools used during the standard operation you would already be having for cervical cancer.