Delayed Sentinel Lymph Node Biopsy in Ductal Cancer in Situ
Sponsored by Uppsala University
About this study
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.
The SentiNot 2.0 protocol aims to elucidate the effectivity and accuracy of the delayed sentinel lymph node dissection concept (dSLND) when upfront SLND is considered unnecessary, such as in the setting of a preoperative diagnosis of DCIS, in cases of unclear BIRADS 4 or 5 lesions that are planned for diagnostic excisional biopsy or in selected cases of risk reducing mastectomy. Acknowledging the large variance of practice in this setting, the study aims to address pragmatism to allow for inclusion. For this reason, the trial is designed separately and independently for mastectomy and breast conserving surgery, so that participating sites can recruit as fitting in their practice. In patients included in the SentiNot 2.0 trial, SPIO (MagTrace,2.0 ml) is injected up to 24 hours preoperative…
Where this study is enrolling
- I'm interested
Baylor College Of Medicine
Houston, Texas
Who can participate
Inclusion criteria
- ✓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).
Exclusion criteria
- ✕Intolerance/hypersensitivity to iron, dextran compounds or SPIO
- ✕An iron overload disease
- ✕Patient deprived of liberty or under guardianship
- ✕Pregnant or lactating patients
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Trial data sourced from ClinicalTrials.gov.