Clinical Trial

Delayed Sentinel Lymph Node Biopsy in Ductal Cancer in Situ

Study acronym: SENTINOT_2
Recruiting Phase 3
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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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2021-01-20; most recent amendment 2023-08-02.
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 DCIS, Breast Cancer, Breast Neoplasms, Sentinel Lymph Node
Enrollment 500 participants
Start Date 2020-03-01
Primary Completion 2026-12-30 (estimated)
Study Completion 2027-12-30 (estimated)
Updated on ClinicalTrials.gov 2023-08-03