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New treatment option for DCIS
Official title Delayed Sentinel Lymph Node Biopsy in Ductal Cancer in Situ
ClinicalTrials.gov ID: NCT04722692
What this study is testing
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join 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...
- 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...
- 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...
You likely can't join if
- Intolerance/hypersensitivity to iron, dextran compounds or SPIO
- An iron overload disease
- Patient deprived of liberty or under guardianship
- Pregnant or lactating patients
See the full eligibility 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...
- 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 above mentioned categories with a preoperative diagnosis of pleomorphic Lobular Cancer in Situ (pLCIS), classic Lobular Neoplasia (LN) or Atypical Ductal Hyperplasia (ADH).
- Intolerance/hypersensitivity to iron, dextran compounds or SPIO
- An iron overload disease
- Patient deprived of liberty or under guardianship
- Pregnant or lactating patients
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
- Hong Kong, Hong Kong
- Falun, Dalarna County, Sweden
- Vaxjo, Kronoberg County, Sweden
- Lund, Skåne County, Sweden
- Västerås, Västmanland County, Sweden
- Gothenburg, Västra Götaland County, Sweden
- Uppsala, Sweden
- Linköping, Östra Götaland, Sweden
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States; Hong Kong, Hong Kong; Falun, Dalarna County, Sweden; Vaxjo, Kronoberg County, Sweden; Lund, Skåne County, Sweden; Västerås, Västmanland County, Sweden and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.