SentiMAG multicentre trial
Completed
- Conditions
- Breast CancerCancerMalignant neoplasm of breast
- Registration Number
- ISRCTN35827879
- Lead Sponsor
- King's College London (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- 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
3. Patients with an iron overload disease
4. Patients with pacemakers or other implantable devices in the chest-wall
5. Intolerance / hypersensitivity to patent blue dye in centres where this is used routinely
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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>MRI sub protocol: Accuracy of MRI for the localisation of SLNs.
- Secondary Outcome Measures
Name Time Method Morbidity from SLNB including lymphoedema, numbness, seroma, cutaneous staining, shoulder stiffness, chronic pain and locoregional recurrence.