Actively Recruiting
Delayed Sentinel Lymph Node Biopsy in Ductal Cancer in Situ
Led by Uppsala University · Updated on 2023-08-03
500
Participants Needed
9
Research Sites
408 weeks
Total Duration
On this page
Sponsors
U
Uppsala University
Lead Sponsor
V
Västmanlands Hospital, Västerås, Sweden
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Delayed Sentinel Lymph Node Biopsy in Ductal Cancer in Situ
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 18 years or older
- Preoperative diagnosis of ductal carcinoma in situ (DCIS) of any grade and size if planned for mastectomy
- Planned risk-reducing mastectomy considered for upfront sentinel lymph node dissection due to institutional practice or individual recommendation
- Preoperative diagnosis of pre-invasive or unclear lesions where upfront SLND would otherwise be considered, including:
- DCIS grade 3 of any size or DCIS grade 2 larger than or equal to 20 mm planned for breast conserving surgery
- DCIS on biopsy with palpable mass or mass effect on radiology
- DCIS with suspicion of micro-invasion on biopsy
- Suspicious mammographic/ultrasound/MRI findings (BIRADS 4 or 5) planned for diagnostic excision without definitive invasive cancer diagnosis
- DCIS planned for complex oncoplastic procedure
- DCIS planned for procedures that may affect future SLND detection rate
- Patients with pleomorphic lobular cancer in situ, classic lobular neoplasia, or atypical ductal hyperplasia meeting above categories
You will not qualify if you...
- Allergy or intolerance to iron, dextran compounds, or SPIO
- Presence of iron overload disease
- Patients deprived of liberty or under guardianship
- Pregnant or lactating women
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Trial Site Locations
Total: 9 locations
1
Baylor College Of Medicine
Houston, Texas, United States, 77030
Actively Recruiting
2
The University of Hong Kong-Shenzhen Hospital
Hong Kong, Hong Kong
Actively Recruiting
3
Falun Lasarett
Falun, Dalarna County, Sweden, 791131
Actively Recruiting
4
Växjö County Hospital
Vaxjo, Kronoberg County, Sweden, 35434
Actively Recruiting
5
Skåne University Hospital
Lund, Skåne County, Sweden, 2242
Actively Recruiting
6
Västmanland County Hospital
Västerås, Västmanland County, Sweden, 72335
Actively Recruiting
7
Sahlgrenska University Hospital
Gothenburg, Västra Götaland County, Sweden, 41346
Actively Recruiting
8
Uppsala University Hospital
Uppsala, Sweden, 75185
Actively Recruiting
9
Linköping University Hospital
Linköping, Östra Götaland, Sweden, 58191
Actively Recruiting
Research Team
A
Andreas Karakatsanis, PhD
CONTACT
F
Fredrik Wärnberg, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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