RecruitingNot ApplicableNCT06463600
Tumour Localisation With Magnetic Clip Before Neoadjuvant Chemotherapy.
Tumour Localisation With Magnetic Clip Before Neoadjuvant Chemotherapy. A Randomised Pilot Feasibility Study: MagLocal 1.0
Sponsor
Sahlgrenska University Hospital
Enrollment
44 participants
Start Date
Feb 1, 2024
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Sex: FEMALEMin Age: 18 Years
Inclusion Criteria5
- Age above 18 years
- Planned for preoperative chemotherapy before breast cancer surgery
- Planned breast conserving surgery with targeted axillary dissection or sentinel lymph node biopsy using magnetic technique
- SLN-biopsy with magnetic tracer or targeted axillary dissection using magnetic tracer and Magseed
- Signed and dated written informed consent before the start of specific protocol procedures
Exclusion Criteria5
- Pregnant or breast-feeding
- Iron overload disease
- Known hypersensitivity to iron or dextran compounds
- Inability to understand given information and give informed consent or undergo study procedures
- Planned MRI control for tumour response during chemotherapy
Interventions
DEVICEMagseed
Tumour localizer
DEVICEMetallic clip and guide wire
Tumour localizers
Locations(1)
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NCT06463600