Breast Cancer Cancer Malignant neoplasm of breast
Conditions
Interventions
or radioisotope alone) or the new technique (magnetic tracer and hand-held magnetometer). Interventions are the injection of the radioisotope, blue dye and magnetic tracer. Furthermore the detection a
Sponsors
King's College London (UK)
Eligibility
Sex/Gender
Female
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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). MRI sub protocol: Accuracy of MRI for the localisation of SLNs. | — |
Secondary
| Measure | Time frame |
|---|---|
| Morbidity from SLNB including lymphoedema, numbness, seroma, cutaneous staining, shoulder stiffness, chronic pain and locoregional recurrence. | — |
Countries
Netherlands, United Kingdom
Outcome results
None listed