LiSENUS -Lymphatic imaging Sentinel Node Super-Res CEUS
Research type
Research Study
Full title
Detection of metastatic axillary sentinel lymph nodes using ultrafast, super-resolution, dual-contrast enhanced ultrasound imaging in patients with breast cancer
IRAS ID
293812
Contact name
Karina Cox
Contact email
Sponsor organisation
Maidstone and Tunbridge Wells NHS Trust
Eudract number
2021-003796-34
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
Invasive breast cancer affects 46,000 people every year in the UK. Cancerous cells can spread to armpit lymph nodes through tissue fluid channels and patients may need more extensive treatment if cancer deposits (metastases) are found. Currently, the best way to find cancerous lymph nodes is to surgically remove them and look for metastases. Armpit surgery is necessary because there are no radiology tests reliable enough to replace the operation.
Most armpit surgery involves the removal of sentinel nodes, which are the first lymph nodes to receive tissue fluid from the breast. If clear of cancer, the rest of the armpit lymph nodes are also likely to be cancer free. Sentinel node removal can cause wound infections (1/10) and long-term arm swelling (1/20). As less than 1/3 of patients have metastases in lymph nodes, about 32,500 patients have unnecessary surgery every year.
The aim of this research is to develop a contrast ultrasound package (made up of software and equipment) that can be used with ultrasound machines in the breast clinic for armpit scanning. The research builds on technology developed at Imperial College and combines it with studies pioneered at Maidstone using tiny gas filled microbubbles (ultrasound contrast) injected into the breast to find sentinel nodes.
Sixty breast cancer patients will have the contrast ultrasound procedure at either Maidstone or Charing Cross Hospitals with microbubbles injected into a vein and into the breast. The aim of the clinical studies are to ensure the new ultrasound test can find sentinel node metastases as well as being easy to use, safe, comfortable and cost effective for the NHS. The creation of a contrast ultrasound test to replace armpit surgery promises to improve the quality of life for patients and be cheaper than an operation.REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
21/NE/0150
Date of REC Opinion
12 Oct 2021
REC opinion
Further Information Favourable Opinion