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NCT04722692 · ClinicalTrials.gov registry record · Phase 3
Delayed Sentinel Lymph Node Biopsy in Ductal Cancer in Situ
A Phase 3 study of Breast Cancer and Breast Neoplasms, sponsored by Uppsala University.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 500
- Enrollment target
- 9
- Study locations
NCT04722692: Recruiting Phase 3 study of Breast Cancer and Breast Neoplasms, sponsored by Uppsala University.
NCT04722692 is a Phase 3 study of Breast Cancer and Breast Neoplasms that is actively recruiting participants, run by Uppsala University. The registered enrollment target is 500 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (82% lower). The trial reports 9 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04722692, a Phase 3 study of Breast Cancer and Breast Neoplasms, is actively recruiting participants, sponsored by Uppsala University.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 500 participants
- Enrollment target
- 9
- Study locations
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.
Primary Outcome
Number of subjects in whom SPIO detected at least one node divided by the number of subjects who underwent the SLND procedure. Analyses will be performed cumulatively and +/-BD and per type of surgery (BCT or mastectomy).
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 |
What NCT04722692 shows while recruiting
NCT04722692 is an interventional study that assigns participants to a tested intervention. The registered 500 participants enrollment target is mid-sized for trials with a published cap, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (82% lower).
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.
NCT04722692 lists 9 locations in 8 states (Other, Texas, Dalarna County).
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.
What interventions are being tested in trial NCT04722692?
The interventions under investigation include: Delayed SLND (DIAGNOSTIC_TEST), Late SLND (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT04722692?
This trial is sponsored by Uppsala University, which has 2 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04722692's enrollment target sits among peer trials
500 193rd of 1224 higher than 1,022 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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