Breast cancer Cancer Breast cancer
Conditions
Interventions
Patients partaking in the study will be allocated to marking of the tumour either with Magseed or a guidewire. Allocation will be performed with block randomisation using a block size of 10 and an all
Sponsors
Uppsala University
Eligibility
Sex/Gender
Female
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 years or older 2. Ductal carcinoma in situ (DCIS) or invasive breast cancer requiring localisation planned for primary surgery including sentinel node biopsy
Exclusion criteria
Exclusion criteria: 1. Intolerance or hypersensitivity to iron or dextran compounds or Sienna XP 2. Iron overload disease 3. Pacemaker or other implantable device in the chest-wall, or prosthesis in the shoulder 4. Deprived of liberty or under guardianship 5. Pregnant or lactating 6. Inability to provide informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Radical excision, defined as free surgical margins of the specimen of the primary tumour according to preoperative diagnosis. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Width of margins per study arm in mm from the tumour to the resection margin both on specimen radiology and on final pathology. 2. Operative time from the beginning of the breast operation until the excision of the specimen in minutes. 3. Intraoperative and postoperative complications on 30 days, described by the Clavien Dindo classification and the Comprehensive Complication Index (CCI) (www.assessurgery.com). 4. Cost/benefit analysis based on the expenses of inpatient and outpatient care regarding the operation and 30 days of the postoperative period. | — |
Countries
Sweden
Outcome results
None listed