Ductal Cancer in Situ (DCIS) Cancer Breast cancer
Conditions
Interventions
Sienna+ (2ml + NaCl 3ml) will be injected in association with the primary breast surgery on patients with a preoperative diagnosis of DCIS. The Sienna+ is injected close to the tumour, subcutaneously.
Sponsors
Uppsala University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with a preoperative diagnosis of DCIS grade 3 any size or, DCIS grade 2 larger than 20 mm on mammography and planned for breast conserving surgery (BCS) 2. Patients with a preoperative diagnosis of DCIS, any grade and any size, planned for mastectomy
Exclusion criteria
Exclusion criteria: 1. Patients undergoing a direct reconstruction with autologous tissue 2. Intolerance/hypersensitivity to iron or dextran compounds or Sienna+ 3. Patients with an iron overload disease 4. Patients with pacemakers or other implantable devices in the chest-wall, or prosthesis in the shoulder 5. Patient deprived of liberty or under guardianship 6. Pregnant or lactating patients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of SNB procedures spared, defined as those cases of patients with a definite postoperative diagnosis of pure DCIS in whom no SNB will be performed | — |
Secondary
| Measure | Time frame |
|---|---|
| SNB detection rate in a second operation, defined as the number of successful SNBs for each patient and for each method (SPIO, isotope and blue dye) divided by the total amount of SNBs performed | — |
Countries
Sweden
Outcome results
None listed