Breast Cancer Sentinel Lymph Node Biopsy (SLNB) Detection of Lymph Node metastases using MRI
Conditions
Interventions
or radioisotope alone) or the new technique (magnetic tracer and hand-held magnetometer).
Pre- and post contrast MRI scan of the axilla.
Sponsors
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.
Eligibility
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. Exclusion criteria MRI subprotocol: 1. Presence of implantable devices (electronically, magnetically, mechanically activated. E.g: cardioverter defibrillators, cardiac pacemakers; 2. Metallic splinters in the eye; 3. Ferromagnetic haemostatic clips in the central nervous system; 4. Pregnancy; 5. Claustrophobia.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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). Primary outcome MRI subprotocol: Accuracy of MRI for the localisation of SLNs. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome SLNB technique: Morbidity from SLNB including lymphoedema, numbness, seroma, cutaneous staining, shoulder stiffness, chronic pain and locoregional recurrence. Secondary outcome MRI subprotocol: Detection of metastases (macro and micrometastases). | — |
Contacts
Public ContactMaarten Grootendorst
Roelof van Schevenstraat 59
Outcome results
None listed