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Delayed Sentinel Lymph Node Biopsy in Ductal Cancer in Situ
Sponsor: Uppsala University
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.
Official title: Sentinel Lymph Node Biopsy in Ductal Cancer in Situ or Unclear Lesions of the Breast and How to Not do it. An Open-label, Phase 3, Randomised Controlled Trial. (SentiNot 2.0).
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
500
Start Date
2020-03-01
Completion Date
2027-12-30
Last Updated
2023-08-03
Healthy Volunteers
No
Interventions
Delayed SLND
SLND performed after surgery for DCIS or other pre-invasive lesions, where final pathology showed invasive breast cancer. Patients have received SPIO in the breast at the first operation, prior to dissection and resection and the SLN has already been marked with SPIO. These SLNs are to be removed. SLND is divided into the following steps: 1. Transcutaneous signal 2. Incision in the axilla (skin, subcutaneous fat and fascia) and "In situ" signal 3. SLN identification "in situ" 4. SLN excision and signal "ex vivo" 5. Background axillary counts. For step "d" the radioactive counts are registered for each SLN that has been excised. When the procedure is completed successfully with SPIO, then background axillary isotope counts are registered and, if present, SLND continues as described above with the isotope as primary tracer.
Late SLND
SLND performed after surgery for DCIS or other pre-invasive lesions, where final pathology showed invasive breast cancer. Patients will be injected with radioisotope in the operated breast before SLND according to standard of care. Any SLNs detected with this intervention are to be removed. SLND is divided into the following steps: 1. Transcutaneous signal 2. Incision in the axilla (skin, subcutaneous fat and fascia) and "In situ" signal 3. SLN identification "in situ" 4. SLN excision and signal "ex vivo" 5. Background axillary counts. For step "d" the magnetic counts are registered for each SLN that has been excised. When the procedure is completed successfully with the isotope, then background axillary iSPIO counts are registered and, if present, SLND continues as described above with the SPIO as primary tracer.
Locations (9)
Baylor College Of Medicine
Houston, Texas, United States
The University of Hong Kong-Shenzhen Hospital
Hong Kong, Hong Kong
Falun Lasarett
Falun, Dalarna County, Sweden
Växjö County Hospital
Vaxjo, Kronoberg County, Sweden
Skåne University Hospital
Lund, Skåne County, Sweden
Västmanland County Hospital
Västerås, Västmanland County, Sweden
Sahlgrenska University Hospital
Gothenburg, Västra Götaland County, Sweden
Uppsala University Hospital
Uppsala, Sweden
Linköping University Hospital
Linköping, Östra Götaland, Sweden