Lymph Node Identification Using Magtrace and Magseed Before Chemotherapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

459 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-12-01

Study Completion Date

2028-12-31

Brief Summary

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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 identification.

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Detailed Description

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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 moths later. The investigators also want to see if they can find the same nodes with a tracer injected before chemotherapy as with a tracer injected after chemotherapy. The hypothesis is that the chemotherapy might affect the lymph drainage and the nodes marked before the chemotherapy are the true sentinel lymph nodes.

Furthermore, in patients with known lymph node metastases before chemotherapy one metastasis is marked with a magnetic clip before the chemotherapy. This is a well known method but it has not been done in combination with the magnetic tracer. We will show that this is feasible.

All patients included in the study will receive their treatments according to the current standard national guidelines as both the magnetic tracer and the routinely used radioactive tracer are used in parallel. The magnetic clip is also used at several sites in Sweden today.

Conditions

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Breast Cancer

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Node negative

Clinically node negative before neoadjuvant chemotherapy

Magtrace

Intervention Type DEVICE

Sentinel lymph node tracer and metastatic lymph node clip

Node positive

Clinically node positive before neoadjuvant chemotherapy

Magtrace

Intervention Type DEVICE

Sentinel lymph node tracer and metastatic lymph node clip

Interventions

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Magtrace

Sentinel lymph node tracer and metastatic lymph node clip

Intervention Type DEVICE

Other Intervention Names

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Magseed

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No