Actively Recruiting
Sentinel Lymph Node Biopsy in Ductal Cancer in Situ or Unclear Breast Lesions Evaluating Delayed Surgery Using Magnetic and Radioactive Tracers. Open-label Phase 3 Randomized Trial
Led by Uppsala University · Updated on 2023-08-03
500
Participants Needed
9
Research Sites
52 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
This research investigates the use of superparamagnetic iron oxide (SPIO) nanoparticles as a tracer for delayed sentinel lymph node dissection (d-SLND) in women with breast conditions where immediate axillary surgery is not needed. This includes patients with a preoperative diagnosis of ductal carcinoma in situ (DCIS), unclear suspicious breast lesions, or those planned for risk-reducing mastectomy. The study aims to assess the effectiveness and accuracy of the delayed SLND approach, allowing some patients to avoid upfront surgery in the axilla. Participants receive an injection of SPIO near the breast lesion during their primary breast surgery, either up to 24 hours before or during the operation. If the final pathology shows invasive breast cancer, a second operation is performed to remove the sentinel lymph nodes (SLNs) using either SPIO or a radioactive tracer, depending on random assignment. The procedure involves multiple steps including detection of magnetic and radioactive signals, incision, SLN identification, and removal. Blue dye may also be used to assist in locating the nodes. During the study, patients undergo initial breast surgery with SPIO injection and magnetic signal detection but no immediate SLN removal. If invasive cancer is found, the delayed SLND procedure is done later with additional tracers. Researchers measure detection rates of SLNs, concordance between methods, and malignancy rates. Safety and procedure success are closely monitored. The study includes a control group receiving standard upfront SLND, and participants are followed until the study ends in 2027.
CONDITIONS
Brief 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 where sentinel lymph node dissection (SLND) would be considered
- Preoperative diagnosis of pre-invasive or unclear breast lesions where upfront SLND is otherwise considered, including but not limited to:
- DCIS grade 3 of any size or DCIS grade 2 larger than or equal to 20 mm planned for breast conserving surgery
- DCIS with a palpable mass or mass effect on imaging
- DCIS with suspicion of micro-invasion
- Suspicious BIRADS 4 or 5 lesions planned for diagnostic excision without definitive invasive cancer diagnosis
- DCIS planned for complex oncoplastic procedures or procedures that may affect future SLND detection
- Preoperative diagnosis of pleomorphic lobular cancer in situ (pLCIS), classic lobular neoplasia (LN), or atypical ductal hyperplasia (ADH)
You will not qualify if you...
- Allergy or intolerance to iron, dextran compounds, or SPIO
- Having an iron overload disease
- Being deprived of liberty or under guardianship
- Pregnant or lactating patients
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants receive an injection of SPIO near the breast lesion up to 24 hours before or during primary breast surgery. The sentinel lymph node is marked with SPIO but not removed during this surgery.
1 surgical visit (in-person)
Duration - Second surgery scheduled after pathology results
If invasive breast cancer is detected after primary surgery, participants undergo a second operation for sentinel lymph node dissection using either SPIO or radioisotope as the primary detection method depending on randomization.
1 surgical visit (in-person)
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
F
Fredrik Wärnberg, PhD
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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