Magseed Pro V1

• Research type

  Research Study

• Full title

  A prospective, multi center, international, open label study of the use of Magseed Pro® markers and Sentimag® Gen3 system to localise breast lesions and suspicious/biopsy-proven positive lymph nodes in breast cancer patients.

• IRAS ID

  301757

• Contact name

  Matt Womack

• Contact email

  clinical@endomag.com

• Sponsor organisation

  Endomagnetics

• Clinicaltrials.gov Identifier

  NCT05142787

• Duration of Study in the UK

  1 years, 5 months, 15 days

• Research summary

  The purpose of this study is to provide prospective evidence that the Magseed Pro® marker/Sentimag® Gen3 system is safe and effective for marking
  A. suspicious/biopsy-proven positive axillary lymph nodes; and
  B. soft tissue lesions including cancer and pre-cancerous change in the breast

  Guide wires and I seeds have been used to localise and selectively remove breast lesions and axillary lymph nodes as part of Breast Conserving Surgery (BCS) and targeted axillary dissection procedures. The seeds were first used to localise non-palpable breast lesions, and has replaced the use of wire localisation in many centres with the benefit of improved patient comfort and more efficient surgical workflow. However because I seeds contain radioactive material, there are significant safety and regulatory constraints that must be in place for their use.
  The original Sentimag® and Magseed marker system offered the advantages of seeds without the burden, and allowed for the use of wire free BCS and targeted axillary dissection in wider population thus sparing breast cancer patients the morbidity of extensive axillary surgery when considered to be of oncological benefit.
  The next Generation Sentimag® and Magseed marker have been designed to provide additional benefits, including a measuring mode which informs the surgeon of the distance to the probe marker, eliminates signal drift and has the ability to discriminate Magseed Pro® marker.
  The Sentimag® Gen3 unit also has improved user interface features which aim to improve ease of use.

• REC name

  West Midlands - South Birmingham Research Ethics Committee

• REC reference

  22/WM/0012

• Date of REC Opinion

  28 Feb 2022

• REC opinion

  Further Information Favourable Opinion