SMART STUDY : Version 6 dated 27th January 2016
Research type
Research Study
Full title
Sentimag along with routine technique in detection of Sentinel node biopsy
IRAS ID
182909
Contact name
Raghavan Vidya
Contact email
Sponsor organisation
The Royal Wolverhampton NHS Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
Doctors look for and remove the sentinel lymph node in order to assess the stage of breast cancer. This is called a sentinel lymph node biopsy. To find the sentinel lymph node, doctors usually inject a blue dye and radioactive tracer into the breast and use a handheld gamma probe to locate the nodes. They do it as an operation while the patient is under a general anaesthetic .\nThe researchers would like to look at a new magnetic tracer (Sienna+) and a magnetic detector (Sentimag) to find where the sentinel lymph nodes are as well as the standard technique. The magnetic technique is approved for use, and the researchers consider it may be just as good as the blue dye and radioactive tracer, but without the side effects. They want to find out if this is so. In this study the doctor will be using both techniques to detect each patient’s sentinel lymph nodes.\n\nFive published clinical trials with the magnetic technique (including the UK based Sentimag trial) have shown that the magnetic tracer is as good as standard technique in detecting sentinel node biopsy. In this study we are looking to see if the same results can be reproduced.
REC name
West Midlands - Solihull Research Ethics Committee
REC reference
16/WM/0118
Date of REC Opinion
21 Apr 2016
REC opinion
Further Information Favourable Opinion