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 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

Trial Details

NCT ID
NCT04722692
Phase
PHASE3
Sponsor
Uppsala University
Status
RECRUITING
Cancer Type
Lobular Carcinoma Breast Cancer
Interventions
  • Delayed SLND
  • Late SLND
Locations (sample)
  • Houston, Texas, United States|29.76328,-95.36327
  • Hong Kong, Hong Kong|22.27832,114.17469
  • Falun, Dalarna County, Sweden|60.60357,15.62597
  • Vaxjo, Kronoberg County, Sweden|56.87767,14.80906
  • Lund, Skåne County, Sweden|55.70584,13.19321

Key Eligibility 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 recom…
  • C. Any case with a preoperative diagnosis of pre-invasive or unclear lesion, that upfront SLND would be otherwise considered, such as, but not limi…
  • 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 breas…

For full eligibility, visit ClinicalTrials.gov.

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