RecruitingNot ApplicableNCT06463600

Tumour Localisation With Magnetic Clip Before Neoadjuvant Chemotherapy.

Tumour Localisation With Magnetic Clip Before Neoadjuvant Chemotherapy. A Randomised Pilot Feasibility Study: MagLocal 1.0


Sponsor

Sahlgrenska University Hospital

Enrollment

44 participants

Start Date

Feb 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The feasibility of the use of magnetic clips for tumour localisation before preoperative chemotherapy in combination with superparamagnetic iron oxide nanoparticles (SPIO) as tracer for sentinel lymph node (SLN) detection and in combination with a magnetic clip in the index lymph node metastasis is studied.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study evaluates using a magnetic clip (Magseed) to mark a breast tumor before starting chemotherapy, so surgeons can precisely locate and remove the correct tissue during surgery after chemotherapy has potentially shrunk or shifted the tumor. **You may be eligible if...** - You are 18 or older and planned for chemotherapy before breast cancer surgery - You are scheduled for breast-conserving surgery with targeted axillary dissection or sentinel lymph node biopsy using magnetic technique - You have signed informed consent before the procedure **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have an iron overload condition - You have a known allergy to iron or dextran compounds - You are unable to understand the study information or give consent - You are planned to have an MRI scan to check tumor response during chemotherapy (the clip may interfere) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEMagseed

Tumour localizer

DEVICEMetallic clip and guide wire

Tumour localizers


Locations(1)

Sahlgrenska Academy at Gothenburg University

Gothenburg, Göteborg, Sweden

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NCT06463600


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