Using a low dose of Magtrace to locate lymph nodes in breast cancer patients
Official title: Sentinel Lymph Node Localisation With an Ultra-low Dose of Superparamagnetic Iron Oxide Nanoparticles in Patients With Breast Cancer
Run by Vastra Gotaland Region · NCT06169072 · Data updated 2026-11-12
This study is testing if a low dose of a new tracer can help find lymph nodes in breast cancer patients as well as the traditional methods do.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 220 (estimated) |
| Sponsor | Vastra Gotaland Region Government |
| Locations | 1 site (Gothenburg) |
| Status | Recruiting |
| Started | January 1, 2023 |
| Main results expected | July 1, 2024 |
| Study ends | July 1, 2027 |
| Registry record updated | January 26, 2024 |
| Trial ID | NCT06169072 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are breast cancer patients scheduled for sentinel lymph node biopsy.
✕Probably not a fit
Patients who are pregnant, breastfeeding, or have iron overload disease may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to evaluate the effectiveness of superparamagnetic iron oxide nanoparticles (SPIO) as a tracer in an ultra-low dose for sentinel lymph node (SLN) detection in breast cancer patients. Participants will undergo SLN biopsy using both the SPIO method and the traditional dual technique involving Technetium99m and possibly blue dye. The study will compare the detection rates of SLNs between these two methods and assess any MRI breast artefacts and skin staining over time. This prospective cohort study will provide insights into the non-inferiority of the new technique compared to the standard approach.
Why it matters
Potential benefit: If successful, this study could provide a safer and more effective method for sentinel lymph node detection in breast cancer patients.
How similar studies have gone: Other studies have shown promise with similar approaches using superparamagnetic nanoparticles, indicating potential for success.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Planned for sentinel lymph node biopsy at (or after) breast surgery * Signed and dated written informed consent before the start of specific protocol procedures Exclusion Criteria: * Pregnant or breast-feeding * Iron overload disease * Known hypersensitivity to iron, dextran compounds or blue dye. * Inability to understand given information and give informed consent or undergo study procedures
Where it's running
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Sahlgrenska Iniversity Hospital
Gothenburg, Sweden Recruiting
Study contacts
- Principal investigator: Fredrik Wärnberg — Sahlgrenska University Hospital
- Study coordinator: Fredrik Wärnberg
- Email: fredrik.warnberg@vgregion.se
- Phone: +4631823931
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Using indocyanine green to find sentinel lymph nodes during mastectomy
This pilot will test whether injecting indocyanine green and using fluorescence during mastectomy can find sentinel lymph nodes in women with clinically node-negative invasive breast cancer.
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Using indocyanine green to identify sentinel lymph nodes during breast cancer surgery
This project tests whether indocyanine green dye and a fluorescence camera can be used instead of the radioactive tracer to find sentinel lymph nodes in adults having breast cancer surgery who are clinically node-negative.
-
Using advanced imaging technology for early-stage breast cancer surgery
This study is testing a new imaging tool during breast cancer surgery to see if it can help doctors find lymph nodes more accurately and improve treatment for patients.
-
New imaging technology for identifying breast cancer and lymph node status
This study is testing a new imaging technology to help doctors better identify breast cancer and check lymph nodes during surgery for patients with breast cancer.
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Tailoring axillary surgery for breast cancer patients
This study is testing if some early breast cancer patients can skip certain surgeries to remove lymph nodes, which might help them avoid unnecessary complications and costs.
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Avoiding sentinel lymph node biopsy in early breast cancer patients
This study is testing whether women with early breast cancer can safely skip a specific lymph node surgery to see if it helps them recover better and have less swelling in their arms.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.