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Delayed Sentinel Lymph Node Biopsy in Ductal Cancer in Situ
NCT04722692 · View on ClinicalTrials.gov ↗
Study 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 (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 Studied
Interventions
- DIAGNOSTIC_TEST Delayed SLND
- DIAGNOSTIC_TEST Late SLND
Study Locations (9)
Other
- The University of Hong Kong-Shenzhen Hospital — Hong Kong
- Uppsala University Hospital — Uppsala
Texas
- Baylor College Of Medicine — Houston
Dalarna County
- Falun Lasarett — Falun
Kronoberg County
- Växjö County Hospital — Vaxjo
Skåne County
- Skåne University Hospital — Lund
Västmanland County
- Västmanland County Hospital — Västerås
Västra Götaland County
- Sahlgrenska University Hospital — Gothenburg
Östra Götaland
- Linköping University Hospital — Linköping
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 500 participants |
| Start Date | 2020-03-01 |
| Est. Completion | 2027-12-30 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04722692
The ClinicalTrials.gov registry entry for NCT04722692 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 500 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Uppsala University, which has 29 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 4 conditions, with Breast Cancer appearing as the primary indexed condition, and to 2 interventions — of which Delayed SLND is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04722692 reports 9 study locations spanning 8 distinct geographic areas — top geographies include Other, Texas, Dalarna County. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04722692 about?
NCT04722692 is a clinical study titled "Delayed Sentinel Lymph Node Biopsy in Ductal Cancer in Situ". 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 ...
What is the current status of trial NCT04722692?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 500 participants. The study started on 2020-03-01. Estimated completion is 2027-12-30.
What conditions does trial NCT04722692 study?
This clinical trial studies the following conditions: Breast Cancer, Breast Neoplasms, DCIS, Sentinel Lymph Node. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04722692?
The interventions under investigation include: Delayed SLND (DIAGNOSTIC_TEST), Late SLND (DIAGNOSTIC_TEST). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04722692?
This trial is sponsored by Uppsala University, which has 29 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04722692 being conducted?
This trial has 9 study locations across Texas, Dalarna County, Kronoberg County, Skåne County, Västmanland County. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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