SentiMag Multicentre Trial.
Recruiting
- Conditions
- Breast CancerSentinel Lymph Node Biopsy (SLNB)Detection of Lymph Node metastases using MRI
- Registration Number
- NL-OMON23320
- Lead Sponsor
- This trial is jointly sponsored by King’s College London and Guy’s & St Thomas’ NHS Trust. The trial is being coordinated by the SentiMAG Trials Office, Department of Research Oncology, King’s College London.
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 160
Inclusion Criteria
1. Patients with breast cancer scheduled for SLNB and who are clinically and radiologically (pre-operative ultrasound normal or indeterminate/abnormal and benign FNA or core biopsy) node negative;
2. Patients available for follow-up for at least 12 months.
Exclusion Criteria
1. Intolerance / hypersensitivity to iron or dextran compounds or Sienna +;
2. Patients who cannot / do not receive radioisotope for SLNB;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary outcome SLNB technique: The proportion of sentinel nodes detected (detection rate) with either the standard (patent blue dye and radioisotope; or radioisotope alone) or the new technique (magnetic tracer and hand-held magnetometer).<br><br /><br /><br>Primary outcome MRI subprotocol: Accuracy of MRI for the localisation of SLNs.
- Secondary Outcome Measures
Name Time Method Secondary outcome SLNB technique: Morbidity from SLNB including lymphoedema, numbness, seroma, cutaneous staining, shoulder stiffness, chronic pain and locoregional recurrence. <br><br /><br /><br>Secondary outcome MRI subprotocol: Detection of metastases (macro and micrometastases).