Delayed Sentinel Lymph Node Biopsy in Ductal Cancer in Situ

Recruiting now · Phase 3

Conditions studied: DCIS, Breast Cancer, Breast Neoplasms, Sentinel Lymph Node

In brief

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.

Key facts

Study ID

NCT04722692

Run by

Uppsala University

People needed

500

Starts

2020-03-01

Expected to finish

2027-12-30

Last updated by the study team

2023-08-03

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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 recommendation.
• C. Any case with a preoperative diagnosis of pre-invasive or unclear lesion, that upfront SLND would be otherwise considered, such as, but not limited to:
• 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 breast conserving surgery or
• Patients with a preoperative diagnosis of DCIS on core biopsy with a palpable mass on clinical examination or mass effect on radiology or
• Patients with a preoperative diagnosis of DCIS with suspicion of micro-invasion on core biopsy or
• Patients with a mammographic/ultrasound/MRI finding, suspicious for breast cancer (BIRADS 4 or 5) planned for diagnostic excision with breast conserving surgery, with no definitive diagnosis of invasive cancer or
• Patients with a preoperative diagnosis of DCIS, any grade, any size and planned for a complex oncoplastic procedure or
• Patients with a preoperative diagnosis of DCIS, any grade, any size and planned for a procedure that may compromise detection rate for a future SLND, such as, but not confined to: lesions in the upper outer quadrant or the axillary tail, removal of the nipple areola complex and so on or
• The above mentioned categories with a preoperative diagnosis of pleomorphic Lobular Cancer in Situ (pLCIS), classic Lobular Neoplasia (LN) or Atypical Ductal Hyperplasia (ADH).

You may not qualify if…

• Intolerance/hypersensitivity to iron, dextran compounds or SPIO
• An iron overload disease
• Patient deprived of liberty or under guardianship
• Pregnant or lactating patients

Where it is running

• Baylor College Of Medicine — Houston, Texas, United States (enrolling)
• The University of Hong Kong-Shenzhen Hospital — Hong Kong, Hong Kong (enrolling)
• Falun Lasarett — Falun, Dalarna County, Sweden (enrolling)
• Växjö County Hospital — Vaxjo, Kronoberg County, Sweden (enrolling)
• Skåne University Hospital — Lund, Skåne County, Sweden (enrolling)
• Västmanland County Hospital — Västerås, Västmanland County, Sweden (enrolling)
• Sahlgrenska University Hospital — Gothenburg, Västra Götaland County, Sweden (enrolling)
• Uppsala University Hospital — Uppsala, Sweden (enrolling)
• Linköping University Hospital — Linköping, Östra Götaland, Sweden (enrolling)

Full record on ClinicalTrials.gov

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