RecruitingOBSERVATIONAL

Audit of Targeted Sentinel Node Biopsy (TSNB) in Patients With Limited Nodal Disease Undergoing Primary Surgery

This study, called NodeSMART, is looking at a new surgical approach for breast cancer patients called Targeted Sentinel Node Biopsy (TSNB). It's for people with a limited number of cancer cells found in their armpit (axillary) lymph nodes before surgery. Normally, doctors would remove many lymph nodes, which can cause swelling and discomfort. TSNB aims to remove only the most important nodes. The study wants to see how well TSNB works compared to standard methods, especially in reducing side effects like arm swelling (lymphoedema), while still effectively treating the cancer. It builds on previous research suggesting that some patients might not need extensive surgery.

At a glance

Status

Recruiting

Sponsor

University Hospitals of Derby and Burton NHS Foundation Trust

Enrolment target

300

Start

17 Jan 2025

Estimated completion

01 Dec 2032

Breast Cancer Axillary Lymph Nodes Dissection Axillary Metastases Sentinel Lymph Node Biopsy (SLNB)Node Positive Breast Cancer Axilla; Breast Axillary Ultrasound

What is this study about?

When breast cancer is diagnosed, doctors often check the lymph nodes in the armpit to see if cancer cells have spread. This is important for deciding on the best treatment. Traditionally, if cancer was found in these nodes, many of them might be removed in a procedure called axillary lymph node dissection (ALND). While effective, ALND can lead to side effects like arm swelling.

More recently, doctors started using a technique called Sentinel Lymph Node Biopsy (SNB), where only a few key nodes (the 'sentinel' nodes) are removed to check for cancer. If cancer is found in only a few of these, sometimes further extensive surgery can be avoided. This study is looking at a slightly different approach called Targeted Sentinel Node Biopsy (TSNB). With TSNB, if a cancer cell is seen in a lymph node on an ultrasound scan before surgery, that specific node is marked and carefully removed along with the usual sentinel nodes. The goal is to be more precise in identifying and removing only the cancerous nodes, potentially reducing the need for more extensive surgery and minimising discomfort and complications like arm swelling.

This study, NodeSMART, will collect information from patients undergoing TSNB to understand how well it works in real-world settings. It will compare the results to earlier studies and standard treatments to see if TSNB leads to fewer side effects and good cancer control. This information will help doctors understand who might benefit most from this less invasive approach.

Key takeaways

This study evaluates Targeted Sentinel Node Biopsy (TSNB) for early breast cancer.
TSNB aims to reduce extensive lymph node surgery and related arm swelling.
It's for breast cancer patients with limited spread to armpit lymph nodes.
The study collects information from routine care, with no extra tests for you.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

This study is looking for women and men, aged 18 or over, who have been diagnosed with breast cancer. You might be suitable if your cancer is in the breast (T1 or T2) and has spread to only one or two lymph nodes in your armpit, as confirmed by a biopsy. You should also be scheduled to have a specific type of surgery called Targeted Sentinel Node Biopsy (TSNB) where a marked node and other sentinel nodes are removed.

However, some people won't be able to join. This includes if you've already had chemotherapy for your breast cancer before surgery, or if you've had lymph nodes removed from the same armpit before. You also won't be eligible if your breast cancer is more advanced (T3 or T4) or if more than two lymph nodes in your armpit show signs of cancer on your scans.

Quick self-check

Are you 18 years old or older?
Do you have T1 or T2 breast cancer?
Have cancer cells been found in 1 or 2 lymph nodes in your armpit confirmed by biopsy?
Are you having surgery before any chemotherapy?
Have you *not* had previous armpit lymph node surgery?
Are you scheduled for a Sentinel Lymph Node Biopsy?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, the main part of your involvement will be undergoing the specific surgical procedure called Targeted Sentinel Node Biopsy (TSNB) as planned for your breast cancer treatment. This involves your doctor marking a suspicious lymph node (if one was identified) and then removing that marked node along with other 'sentinel' lymph nodes during your surgery. The study itself doesn't involve any extra appointments or treatments beyond your standard care. The medical team will simply collect information from your existing medical records about your surgery, any side effects you experience, and your recovery over time. The total duration of your participation will depend on how long your medical team follows up on your breast cancer treatment, but it won't require any additional effort from you beyond your standard care.

Potential risks and benefits

The potential benefits of participating in this study are that you would be receiving an advanced surgical technique, TSNB, which aims to be less invasive than traditional extensive lymph node surgery, potentially leading to fewer side effects like long-term arm swelling. However, as with any surgery, there are potential risks, including infection, pain, and bleeding. The study itself does not add specific risks beyond those associated with your planned breast cancer surgery. It's important to remember that participation is completely voluntary, and you have the right to withdraw from the study at any time without affecting your medical care.

Locations (12)

Burnley General Teaching Hospital
Burnley, United Kingdom· Recruiting
Addenbrooke's Hospital
Cambridge, United Kingdom· Recruiting
University Hospitals of Derby and Burton
Derby, United Kingdom· Recruiting
Gartnavel General Hospital
Glasgow, United Kingdom· Recruiting
Wycombe Hospital
High Wycombe, United Kingdom· Recruiting
Liverpool University Hospitals NHS Foundation Trust
Liverpool, United Kingdom· Recruiting
Royal Alexandra Hospital
Paisley, United Kingdom· Recruiting
The Shrewsbury and Telford Hospital NHS Trust
Shrewsbury, United Kingdom· Recruiting
Mersey and West Lancashire Teaching Hospitals
St Helens, United Kingdom· Recruiting
University Hospital of North Tees and Hartlepool
Stockton-on-Tees, United Kingdom· Recruiting
Warrington and Halton Teaching Hospitals
Warrington, United Kingdom· Recruiting
The Royal Wolverhampton NHS Trust
Wolverhampton, United Kingdom· Recruiting

Common questions

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

Lymph nodes are small glands that are part of your immune system. Doctors check them in breast cancer to see if cancer cells have spread, which helps in planning your treatment.

What is the difference between TSNB and standard surgery?

TSNB is a more targeted surgery. It involves marking and removing a specific suspicious lymph node along with a few other key nodes, aiming to be less extensive than removing all the armpit lymph nodes.

Will I have chemotherapy if I participate in this study?

Patients in this current study are having surgery first and are not receiving chemotherapy before their operation. Chemotherapy might be considered after surgery depending on your individual situation.

What are the potential side effects of this surgery?

The main aim of TSNB is to reduce the risk of side effects like arm swelling (lymphoedema), but some swelling can still occur. Other potential risks, like with any surgery, include pain, bruising, or infection.

Will taking part in this study change my breast cancer treatment?

No, this study is observing the results of a surgical technique that your doctors believe is appropriate for your condition. It does not introduce additional treatments or alter your overall care plan.

How to find out more

Amit Goyal

amit.goyal@nhs.net 01332 786958 Official trial record

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