1) Sentinel Lymph Node metastases in breast cancer patient 2) Cancer in the Sentinel Lymph Node(s)
Conditions
Interventions
The Medisch Spectrum Twente will participate in the MRI subprotocol. As part of
the MRI-subprotocol, patients will undergo an MRI scan of the axilla prior to
the scheduled operation. The scan will t
Sponsors
King's College London
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 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;Patients available for follow-up for at least 12 months
Exclusion criteria
Exclusion criteria: Intolerance / hypersensitivity to iron or dextran compounds or Sienna+;Patients who cannot / do not receive radioisotope for SLNB;Patients with an iron overload disease;Patients with pacemakers or other implantable devices in the chest-wall;Intolerance / hypersensitivity to patent blue dye in centres where this is used routinely;Exlusion criteria MRI-subprotocol:;Presence of implantable devices (electronically, magnetically, mechanically activated. E.g: cardioverter defibrillators, cardiac pacemakers);Metallic splinters in the eye;Ferromagnetic haemostatic clips in the central nervous system;Claustrophobia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end-point: 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). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome measures: Morbidity from SLNB including lymphoedema, numbness, seroma, cutaneous staining, shoulder stiffness, chronic pain and locoregional recurrence. An initial cost-effectiveness evaluation of the new technique will also be performed. Outcome measures MRI subprotocol: evaluate the accuracy of MRI for the localisation of the SLN and the detection of metastasis (macro and micrometastases). | — |
Countries
Netherlands
Outcome results
None listed