Tumour Localisation With Magnetic Clip Before Neoadjuvant Chemotherapy.
ConditionBreast Conserving Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorSahlgrenska University Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Magseed
DeviceTumour localizer
Metallic clip and guide wire
DeviceTumour localizers
Treatment groups
44 Participants
are divided into 2 treatment groupsGroup A: Tumour localisation with MagseedExperimental treatment 1 intervention
Group B: Metallic marker + guide wireActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Specimen volume
The surgical specimen is weighed after removal.
Time frame
PerioperativelySponsors and contacts
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Source ClinicalTrials.gov