MAGSTAR Trial
Research type
Research Study
Full title
MAGnetic versus STAndard technique for sentinel node biopsy in breast cancer compared in a Randomised controlled trial
IRAS ID
164723
Contact name
Michael Douek
Contact email
Sponsor organisation
King's College London
Eudract number
2015-000549-21
ISRCTN Number
ISRCTN20200149
Duration of Study in the UK
6 years, 7 months, 1 days
Research summary
The MAGSTAR trial is a phase III randomised controlled trial (RCT) comparing a new technique for sentinel lymph node biopsy (SLNB) in breast cancer patients against the standard technique. The standard technique for identifying sentinel lymph nodes during surgery involves an injection of both a radioisotope and blue dye. The sentinel node(s) are then located using a gamma probe and discoloration from the dye. With the new technique a magnetic tracer (Sienna+, Endomagnetics Ltd, UK) is injected into the breast and a hand-held probe called a magnetometer (Sentimag, Endomagnetics Ltd, UK) is used to detect the sentinel node(s) during surgery.
The MAGSTAR trial is the first RCT using this technique. We will recruit patients diagnosed with breast cancer and undergoing a SLNB. Patients who agree to participate, will be randomly selected to undergo either the magnetic technique or the standard technique for SLNB. The number of sentinel lymph nodes identified will be recorded for both techniques. The study will compare how effective both techniques are in identifying the sentinel lymph nodes. We will also look at complications related to the two different procedures and other complications from the breast cancer .
The primary end point for the trial will be the amount of sentinel lymph nodes located in each patient for each technique. The secondary end points will look at complications as a result of the two techniques, complications as a result of the breast cancer, recurrence of the breast cancer in the same region and the cost-effectiveness of the two procedures.
REC name
London - Fulham Research Ethics Committee
REC reference
15/LO/0289
Date of REC Opinion
5 Mar 2015
REC opinion
Further Information Favourable Opinion