Using magnetic clips to locate tumors before chemotherapy in breast cancer patients
Tumour Localisation With Magnetic Clip Before Neoadjuvant Chemotherapy. A Randomised Pilot Feasibility Study: MagLocal 1.0
This study is testing if using magnetic clips can help doctors find tumors more accurately in breast cancer patients before they start chemotherapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 44 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Sahlgrenska University Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Gothenburg, Göteborg) |
| Trial ID | NCT06463600 on ClinicalTrials.gov |
What this trial studies
This study investigates the feasibility of using magnetic clips for tumor localization prior to preoperative chemotherapy in breast cancer patients. It combines the use of superparamagnetic iron oxide nanoparticles (SPIO) as a tracer for sentinel lymph node detection with magnetic clips for targeted axillary surgery. The goal is to enhance the accuracy of tumor localization and improve surgical outcomes. Participants will undergo procedures involving Magseed, metallic clips, and guide wires as part of their treatment plan.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old who are scheduled for preoperative chemotherapy and breast-conserving surgery.
Not a fit: Patients who are pregnant, breastfeeding, or have iron overload diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve surgical precision and outcomes for breast cancer patients undergoing chemotherapy.
How similar studies have performed: While the use of magnetic techniques in surgery is gaining interest, this specific approach is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age above 18 years 2. Planned for preoperative chemotherapy before breast cancer surgery 3. Planned breast conserving surgery with targeted axillary dissection or sentinel lymph node biopsy using magnetic technique 4. SLN-biopsy with magnetic tracer or targeted axillary dissection using magnetic tracer and Magseed 5. Signed and dated written informed consent before the start of specific protocol procedures Exclusion Criteria: 1. Pregnant or breast-feeding 2. Iron overload disease 3. Known hypersensitivity to iron or dextran compounds 4. Inability to understand given information and give informed consent or undergo study procedures 5. Planned MRI control for tumour response during chemotherapy
Where this trial is running
Gothenburg, Göteborg
- Sahlgrenska Academy at Gothenburg University — Gothenburg, Göteborg, Sweden (Recruiting)
Study contacts
- Principal investigator: Roger Olofsson Bagge, prof — Sahlgrenska Academy at Gothenburg University
- Study coordinator: Fredrik Warnberg, prof
- Email: fredrik.warnberg@vgregion.se
- Phone: +46706146251
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.