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Delayed Sentinel Lymph Node Biopsy in Ductal Cancer in Situ

Study acronym: SENTINOT_2
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Site contacts updated at 1 of 9 sitesv3
  2. Site details revised at 1 of 9 sitesv2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Uppsala University
109 trials monitored
See 3 trials at risk
Breast Cancer
5,418 trials monitored
See 296 trials at risk
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.
Trial Details
NCT Number NCT04722692
Lead Sponsor Uppsala University
Collaborators: Västmanlands Hospital, Västerås, Sweden, Sahlgrenska University Hospital, University Hospital, Linkoeping, Skane University Hospital, Blekinge County Council Hospital, Växjö Hospital, Växjö, Sweden, The University of Hong Kong-Shenzhen Hospital, Norrlands University Hospital, Dalarna County Hospital, Falun, Sweden, Baylor College of Medicine
Conditions
(from sponsor)		 DCIS, Breast Cancer, Breast Neoplasms, Sentinel Lymph Node
Related terms Breast Neoplasms, Carcinoma, Intraductal, Noninfiltrating
Enrollment 500 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov