Sentinel node biopsy in breast cancer Cancer Malignant neoplasm of breast
Conditions
Interventions
The allocation of the cohorts will be performed as follows: The first cohort, i.e. patients with an intraoperative injection of 1.5 ml SiennaXP will be recruited and completed first. The patients recr
Sponsors
Uppsala University Hospital (Akademiska)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subject has a medical record documentation of a diagnosis of primary breast cancer (invasive or in-situ Tis-T2, clinical size up to 5.0 cm) 2. Subject has been scheduled for surgical intervention, with a lymph node biopsy procedure being a part of the surgical plan 3. Subject is =18 years old at time of consent 4. Subject has an ECOG performance status of Grade 0-2 5. Subject has a clinical negative node status (N0) 6. Subject has no evidence of general metastases (M0) 7. Subject is available for the follow-up defined in the applied study protocol
Exclusion criteria
Exclusion criteria: 1. Subject is pregnant or lactating 2. Subject has evidence of metastatic cancer (M1) 3. Subject has evidence of node positive disease (N1) 4. Subject has locally advanced breast cancer (T4) 5. Subject has previous axilla surgery, reduction mammoplasty, or lymphatic function that is impaired in the surgeon’s judgment 6. Subject has had preoperative radiation therapy to the affected breast or axilla or neoadjuvant chemotherapy. 7. Subject has an iron overload disease 8. Subject has a known hypersensitivity to blue dye 9. Subject has intolerance or hypersensitivity to iron or dextran compounds, or to SiennaXP® 10. Subject has a pacemaker or other implantable device in the chest wall or shoulder 11. Subject is indicated or scheduled for post-operative MRI investigation of the breast 12. Subject has lesions which could pre-operatively only be visualized by MRI investigation of the breast 13. Subject is deprived of liberty or under guardianship 14. Subject is not able to follow and understand the procedures of the study due to mental state or other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of successful sentinel node biopsies (SLNB detection rate per patient) with SiennaXP®, measured intraoperatively | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The average number of excised sentinel lymph nodes per patient, measured intraoperatively 2. The proportion of SLN detected (nodal detection rate), measured intraoperatively 3. The proportion of pathologically positive results (malignancy rate) per patient and per node, measured intraoperatively 4. All adverse events and serious adverse events, measured intraoperatively 5. All device-related adverse and serious adverse events related to the magnetic detection procedure. Patients will be followed up at baseline (directly postoperatively and at 6, 12, and 24 months postoperatively | — |
Countries
Sweden
Outcome results
None listed