Breast Conserving Surgery
Conditions
Keywords
Breast cancer, Tumour localisation, Magnetic clip, magnetic tracer, Preoperative chemotherapy
Brief summary
The feasibility of the use of magnetic clips for tumour localisation before preoperative chemotherapy in combination with superparamagnetic iron oxide nanoparticles (SPIO) as tracer for sentinel lymph node (SLN) detection and in combination with a magnetic clip in the index lymph node metastasis is studied.
Detailed description
The overall aim is to demonstrate that the use of magnetic clips for tumour localisation before preoperative chemotherapy is feasible at breast cancer surgery and histopathological evaluation in combination with superparamagnetic iron oxide nanoparticles (SPIO) as tracer for sentinel lymph node (SLN) detection, and in combination with a magnetic clip in the index lymph node metastasis if targeted axillary surgery is planned.
Interventions
DEVICEMagseed
Tumour localizer
DEVICEMetallic clip and guide wire
Tumour localizers
Sponsors
Sahlgrenska University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
One part feasibility and one part randomised.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age above 18 years 2. Planned for preoperative chemotherapy before breast cancer surgery 3. Planned breast conserving surgery with targeted axillary dissection or sentinel lymph node biopsy using magnetic technique 4. SLN-biopsy with magnetic tracer or targeted axillary dissection using magnetic tracer and Magseed 5. Signed and dated written informed consent before the start of specific protocol procedures
Exclusion criteria
1. Pregnant or breast-feeding 2. Iron overload disease 3. Known hypersensitivity to iron or dextran compounds 4. Inability to understand given information and give informed consent or undergo study procedures 5. Planned MRI control for tumour response during chemotherapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Specimen volume | Perioperatively | The surgical specimen is weighed after removal. |
Countries
Sweden
Contacts
Primary ContactFredrik Warnberg, prof
Backup ContactKian Chin, MD
Outcome results
None listed