Delayed Sentinel Lymph Node Biopsy in Ductal Cancer in Situ
The trial aims to investigate the use of superparamagnetic iron oxide (SPIO) nanoparticles as a tracer for delayed sentinel lymph node dissection (d-SLND) in patients where upfront axillary surgery (SLND) is oncologically deemed unnecessary and should be avoided. This includes but is not limited to patients with a preo
| Condition(s) | DCIS, Breast Cancer, Breast Neoplasms, Sentinel Lymph Node |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| Summary | The trial aims to investigate the use of superparamagnetic iron oxide (SPIO) nanoparticles as a tracer for delayed sentinel lymph node dissection (d-SLND) in patients where upfront axillary surgery (SLND) is oncologically deemed unnecessary and should be avoided. This includes but is not limited to patients with a preoperative diagnosis of ductal cancer in situ of the breast (DCIS), an unclear BIRADS 4-5 planned for diagnostic excision or women planned for risk reducing mastectomy. SPIO is injected in the primary operation, and should final specimen pathology demonstrate invasive breast cancer, only then is an operation in the axilla (d-SLND) performed. |
| Who can participate | Inclusion Criteria: A. Preoperative diagnosis of DCIS, of any grade and any size if planned for mastectomy. B. Planned Risk-reducing mastectomy, if it would be considered for upfront SLND due to institutional practice or in case of an individualised recommendation. C. Any case with a preoperative diagnosis of pre-invasive or unclear lesion, that upfront SLND would be otherwise considered, such as, but not limited to: * Patients with a preoperative diagnosis of DCIS grade 3 any size or, DCIS grade 2 larger than or equal to 20 mm on mammography and planned for breast conserving surgery or * Patients with a preoperative diagnosis of DCIS on core biopsy with a palpable mass on clinical examination or mass effect on radiology or * Patients with a preoperative diagnosis of DCIS with suspicion of |
| Ages | 18 Years |
| Sex | Female |
| Lead sponsor | Uppsala University |
| Locations | Houston, Texas, United States; Hong Kong, Hong Kong; Falun, Dalarna County, Sweden; Vaxjo, Kronoberg County, Sweden; Lund, Skåne County, Sweden; Västerås, Västmanland County, Sweden (+3 more sites) |
| Start date | 2020-03-01 |
| NCT ID | NCT04722692 |
| Official listing | https://clinicaltrials.gov/study/NCT04722692 |