Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Sentinel node detection with 99Tc albumin nanocolloid and indocianine green (ICG) in patients with epithelial ovarian cancer in early stages. Pilot study.

This study aims to improve how doctors find early signs of ovarian cancer spreading. When ovarian cancer cells start to spread, they often go to the closest lymph nodes first. These are called 'sentinel nodes.' Finding and removing these nodes can help doctors understand how advanced the cancer is and plan the best treatment. The study uses two special dyes: one a radioactive substance (technetium Tc 99m albumin nanocolloid) and another a green dye (indocyanine green), injected separately. These dyes help surgeons see and remove the sentinel nodes more easily during surgery. By comparing how well each dye works, and how well they work together, researchers hope to find a more accurate way to detect if the cancer has spread in its early stages.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Fundacio De Recerca Clinic Barcelona-Institut D’investigacions Biomediques August Pi I Sunyer

Enrolment target

Start

25 Sep 2023

Epithelial ovarian cancer in early stages.

What is this study about?

In this study, doctors are trying to find better ways to check if ovarian cancer has started to spread within the body. Ovarian cancer typically starts in the ovaries, and if it spreads, it often goes to the nearest lymph nodes first. These specific lymph nodes, which act like filters in your body's immune system, are called 'sentinel nodes.' Finding these nodes is very important because it helps doctors understand how much the cancer has grown and determine the best treatment plan for you.

The main goal of this study is to see how well a combination of two special substances helps doctors find these sentinel nodes during surgery. One substance is a very small amount of a radioactive material which can be seen with a special camera, and the other is a green dye that glows under a certain light. Both are injected near the tumour. The doctors will compare how accurate each substance is on its own, and how accurate they are when used together, in finding these important lymph nodes.

This is a 'pilot study', which means it's a smaller, early-stage study to see if this method works well and is safe before it might be used in larger studies or become a standard part of care. By doing this, they hope to improve how doctors detect and treat early-stage ovarian cancer, potentially leading to more precise diagnoses and better outcomes for patients in the future.

Key takeaways

This study evaluates new ways to find if early-stage ovarian cancer has spread to lymph nodes.
It uses two special dyes to help surgeons locate 'sentinel nodes' during surgery.
The goal is to improve accuracy in detecting cancer spread.
It's a pilot study, meaning it's a smaller, early-stage research effort.
Participation involves receiving the dyes during your planned ovarian cancer surgery.

Who may be eligible?

To be able to join this study, you need to be at least 18 years old.

This study is specifically for women who have been diagnosed with epithelial ovarian cancer that is in its early stages. This means the cancer has not spread very far.

If you meet these basic criteria, your doctors will do further checks to make sure this study is right and safe for you.

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 at least 18 years old?
Are you female?
Have you been diagnosed with epithelial ovarian cancer?
Is your ovarian cancer in its early stages?
Are you scheduled for surgery for your ovarian cancer?

Answer every question to see your result.

What does participation involve?

If you take part in this study, you will receive two special dyes before or during your surgery for ovarian cancer. One dye is a small amount of a radioactive substance, and the other is a green dye. These dyes are used to help your surgeon find and remove specific lymph nodes, called sentinel nodes, during your operation. The doctors will then check how well these dyes worked together to find these nodes.

Apart from receiving these dyes as part of your surgery, the study will also involve closely looking at your medical details, including your cancer characteristics, the results of your surgery, and how you recover afterwards. Your care team will monitor any complications that might happen after your surgery to see if they are related to using these dyes. The total duration of your participation will depend on your hospital stay and recovery following your surgery.

Potential risks and benefits

Participating in this study might offer some potential benefits, such as contributing to a better understanding of how to detect ovarian cancer spread more accurately, which could improve future treatments for other patients. For you personally, it may help your doctors get a clearer picture of your specific cancer. However, as with any medical procedure, there are potential risks, mainly related to the surgery itself and potentially minor reactions to the dyes used, though these are typically rare. You will be monitored closely for any complications. Remember, you have the right to withdraw from the study at any time without 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
Spain

Common questions

What are lymph nodes and why are they important for ovarian cancer?

Lymph nodes are small, bean-shaped glands that are part of your body's immune system. For ovarian cancer, they are important because they are often the first place cancer cells spread to outside the ovary. Finding out if cancer has spread to these 'sentinel nodes' helps doctors plan the best treatment.

What is a 'sentinel node'?

A sentinel node is the first lymph node or group of nodes that cancer cells are most likely to spread to from the main tumour. Finding and examining these nodes can tell doctors if the cancer has started to spread.

What are the special dyes used in the study?

The study uses two types of dyes: a very small amount of a radioactive substance (technetium Tc 99m albumin nanocolloid) and a green dye (indocyanine green). These are injected to help surgeons locate the sentinel nodes during your operation.

Will using these dyes change my surgery?

The dyes are used during your planned surgery to help your surgeon find the sentinel lymph nodes more precisely. The purpose is to enhance the method of node detection, rather than to change the nature of the surgery itself.

Is this treatment available to everyone with ovarian cancer?

No, this is a research study (a 'pilot study') looking at a new method. It's not yet a standard treatment. Only patients who meet specific criteria, like having early-stage epithelial ovarian cancer, would be eligible to take part in this particular study.