Finding sentinel and targeted lymph nodes with Magtrace and Magseed placed before chemotherapy
Axillary Lymph Node Identification Before Neoadjuvant Chemotherapy Using Magtrace, (Superparamagnetic Iron Oxide Nanoparticles, SPIO) and Magseed, in Clinically Node Negative and Node Positive Patients. SentiNeo 2.0
This will test whether injecting a magnetic tracer (Magtrace) and placing a magnetic clip (Magseed) before neoadjuvant chemotherapy lets surgeons find the sentinel and targeted lymph nodes at surgery in people with breast cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 459 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Vastra Gotaland Region Government |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Gothenburg) |
| Trial ID | NCT06104371 on ClinicalTrials.gov |
What this trial studies
Participants receive a magnetic tracer injection before starting neoadjuvant chemotherapy, and surgeons attempt to detect those marked sentinel lymph nodes at surgery three to six months later. The team will also compare detection of nodes marked before chemotherapy with tracer injections given after chemotherapy to see if the same nodes are found. In patients who had proven lymph node metastasis before chemotherapy, one metastatic node is marked with a magnetic clip (Magseed) before treatment to allow targeted removal. The magnetic techniques are used alongside routine radioactive tracers and all patients receive standard-of-care treatment per national guidelines.
Who should consider this trial
Good fit: Adults with breast cancer scheduled for neoadjuvant chemotherapy who are planned for sentinel lymph node dissection or targeted axillary dissection are ideal candidates.
Not a fit: Patients who are pregnant or breastfeeding, have iron/dextran hypersensitivity or iron overload, require MRI for tumor response assessment, or cannot give informed consent are unlikely to be eligible or to benefit from this approach.
Why it matters
Potential benefit: If successful, this approach could improve accuracy of sentinel and targeted node identification after neoadjuvant chemotherapy and simplify axillary surgery planning.
How similar studies have performed: Magnetic tracers and magnetic clip marking have each been used successfully for node localization, but combining Magtrace injected before chemotherapy with Magseed-marked index nodes in this setting is relatively novel with limited direct data.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: * Patients 18 years of age or older. * Patients with breast cancer planned to undergo NACT with * planned sentinel lymph node dissection (SLND), or * targeted axillary lymph node dissection (TAD), in conjunction with the * breast surgery after NACT. Exclusion Criteria: * Intolerance / hypersensitivity to iron or dextran compounds or SPIO. * Patients who are required to undergo MRI to evaluate tumour response. * Pregnancy or breast feedin.g * Patients with an iron overload disease. * Patient deprived of liberty or under guardianship. * Inability to understand given information and give informed consent or undergo study procedure
Where this trial is running
Gothenburg
- Sahlgrenska University Hospital — Gothenburg, Sweden (Recruiting)
Study contacts
- Study coordinator: Fredrik AM 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.