Status:
RECRUITING
Delayed Sentinel Lymph Node Biopsy in Ductal Cancer in Situ
Lead Sponsor:
Uppsala University
Collaborating Sponsors:
Västmanlands Hospital, Västerås, Sweden
Sahlgrenska University Hospital
Conditions:
DCIS
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief 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 (S...
Detailed Description
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 setti...
Eligibility Criteria
Inclusion
- 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
- Intolerance/hypersensitivity to iron, dextran compounds or SPIO
- An iron overload disease
- Patient deprived of liberty or under guardianship
- Pregnant or lactating patients
Key Trial Info
Start Date :
March 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2027
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT04722692
Start Date
March 1 2020
End Date
December 30 2027
Last Update
August 3 2023
Active Locations (9)
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1
Baylor College Of Medicine
Houston, Texas, United States, 77030
2
The University of Hong Kong-Shenzhen Hospital
Hong Kong, Hong Kong
3
Falun Lasarett
Falun, Dalarna County, Sweden, 791131
4
Växjö County Hospital
Vaxjo, Kronoberg County, Sweden, 35434