Using a low dose of Magtrace to locate lymph nodes in breast cancer patients
Sentinel Lymph Node Localisation With an Ultra-low Dose of Superparamagnetic Iron Oxide Nanoparticles in Patients With Breast Cancer
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 |
| Enrollment | 220 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Vastra Gotaland Region Government |
| Locations | 1 site (Gothenburg) |
| Trial ID | NCT06169072 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are breast cancer patients scheduled for sentinel lymph node biopsy.
Not a fit: Patients who are pregnant, breastfeeding, or have iron overload disease may not benefit from this study.
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 performed: Other studies have shown promise with similar approaches using superparamagnetic nanoparticles, indicating potential for success.
Eligibility criteria
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 this trial is running
Gothenburg
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.