Patients (male or female) with histologically proven non-palpable breast cancer visible on ultrasound and suitable for SLNB
Conditions
Interventions
In addition to the Sienna+ injection, a clip marker will be placed in the MST for reference. In the ZGT the standard procedure with iodine seeds will be performed for reference. The patient will under
Sponsors
Guy's and St Thomas Hospitals, UK
Eligibility
Inclusion criteria
Inclusion criteria: 1) Patients (male or female) with histologically proven non-palpable breast cancer visible on ultrasound and suitable for SLNB. 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. Exclusion criteria MRI subprotocol: 1) Metallic splinters in the eye 2) Ferromagnetic haemostatic clips in the central nervous system. 3) Claustrophobia.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint: 1) Successful localisation (Confirmation that “peak” SentiMag TM readings correspond to centre of the excised lesion on specimen radiograph). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints: 1) Margin involvement 2) re-operation rates 3) SLNB success rates (magnetic technique +/- blue dye and standard technique) 4) Volume of specimen 5) Weight of specimen 6) Operative time 7) Complications 8) Radiological localisation time 9) Patient recorded outcome measures. 10) Cost 11) Accuracy of MRI for the localization of SLNs. | — |
Contacts
Public ContactA. Stam
Medisch Spectrum Twente Postbus 50000
Outcome results
None listed