Status:
NOT_YET_RECRUITING
Lymph Node Identification Using Magtrace and Magseed Before Chemotherapy
Lead Sponsor:
Vastra Gotaland Region
Collaborating Sponsors:
Uppsala University
Region Västmanland
Conditions:
Breast Cancer
Eligibility:
All Genders
18-85 years
Brief Summary
Magnetic tracer injected before preoperative chemotherapy in breast cancer patients for sentinel lymph node detection. Also, magnetic tracer in combination with magnetic clip for index node identifica...
Detailed Description
This is an interventional single arm study. The aim is to see if sentinel lymph nodes marked with a magnetic tracer injected before preoperative chemotherapy can be detected at surgery three to six mo...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
December 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
459 Patients enrolled
Trial Details
Trial ID
NCT06104371
Start Date
December 1 2024
End Date
December 31 2028
Last Update
April 25 2024
Active Locations (1)
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1
Sahlgrenska University Hospital
Gothenburg, Sweden, 413 45