NCT06169072 Sentinel Lymph Node Localisation With an Ultra-low Dose of Magtrace in Breast Cancer Patients
| NCT ID | NCT06169072 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Vastra Gotaland Region |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 220 participants |
| Start Date | 2023-01-01 |
| Primary Completion | 2024-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 220 participants in total. It began in 2023-01-01 with a primary completion date of 2024-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The overall aim is to demonstrate that the use of superparamagnetic iron oxide nanoparticles (SPIO) as a tracer in an ultra-low dose (0.1 ml) is non-inferior for sentinel lymph node (SLN) detection in patients with breast cancer compared to the dual technique using Tc99m +/- blue dye, and to evaluate MRI breast artefacts and skin staining over time.
Eligibility 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
Contact & Investigator
Fredrik Wärnberg
PRINCIPAL INVESTIGATOR
Sahlgrenska University Hospital
Frequently Asked Questions
Who can join the NCT06169072 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06169072 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06169072 currently recruiting?
Yes, NCT06169072 is actively recruiting participants. Contact the research team at fredrik.warnberg@vgregion.se for enrollment information.
Where is the NCT06169072 trial being conducted?
This trial is being conducted at Gothenburg, Sweden.
Who is sponsoring the NCT06169072 clinical trial?
NCT06169072 is sponsored by Vastra Gotaland Region. The principal investigator is Fredrik Wärnberg at Sahlgrenska University Hospital. The trial plans to enroll 220 participants.
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