Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT04722692
PHASE3

Delayed Sentinel Lymph Node Biopsy in Ductal Cancer in Situ

Sponsor: Uppsala University

View on ClinicalTrials.gov

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

DIAGNOSTIC_TEST

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.

DIAGNOSTIC_TEST

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