Premarking of Axillary Nodes Before Start of Neoadjuvant Chemotherapy Using Magnetic Approach

• Status: Recruiting
• Trial end date: 2023-07-01
• Target enrollment: 0
• Participant gender: Female

Summary

Breast cancer is one of the commonest types of cancers in females. Treatments include surgery followed by anti-estrogen therapy, radiotherapy and chemotherapy. During breast surgery, the surgeon removes the cancer from the breast and lymph nodes (glands) from the armpit.

Historically, all armpit lymph nodes were surgically removed but this approach is associated long term problems of arm swelling. In more recent times, an increasingly more selective approach is used to treat the armpit nodes. In the presence of cancer spreads in the nodes, an axillary clearance surgery is done otherwise, only the first node(s) also called sentinel node(s) that drain fluids from the cancer, is surgically removed. The identification of nodes using the latter approach is helped by injecting a tracer in the breast and via the lymphatic channels, the tracer is then concentrated in the sentinel nodes.

Over recent years, neoadjuvant (preoperative) chemotherapy is being increasingly used to treat breast cancers. This treatment approach can lead up to a large of number of complete cancer response. This in turn can cause difficulties in locating the breast cancer / armpit nodes during surgery after the chemotherapy.

New developments like superparamagnetic iron oxide nanoparticles (SPIO or MagTrace®) has been used as an alternate liquid tracer to mark sentinel nodes to facilitate armpit surgery. In addition, small magnetic clip called Magseed® has also been developed which can be inserted into the relevant lymph nodes thereby marking their anatomical position to facilitate surgery. Both MagTrace and Magseed can be used to pre-mark the cancer and armpit nodes before the start of neoadjuvant chemotherapy. In theory, premarking armpit nodes using a magnetic approach is associated with better surgical accuracy in the armpit but there is limited supporting data.

Therefore, this study aims to investigate the feasibility of premarking armpit nodes, with or without cancer spread, using magtrace and magseed respectively before patients undergo neoadjuvant chemotherapy.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Sahlgrenska University Hospital, Sweden
• Collaborator: Uppsala University Hospital

Criteria

Inclusion Criteria:

• A patient meeting the following criteria is eligible for participation in the study:

• Patients 18 years of age or older

• Patients with breast cancer planned to undergo preoperative chemotherapy (NACT) with a) planned sentinel lymph node biopsy (SNB) or b) axillary lymph node dissection, in conjunction with the beast surgery after NACT

Exclusion Criteria:

• Intolerance / hypersensitivity to iron or dextran compounds or SPIO.

• Patients who are required to undergo MR to evaluate tumour response

• Pregnancy or breast feeding

• Patients with an iron overload disease.

• Patient deprived of liberty or under guardianship.

• Inability to understand given information, give informed consent, undergo study procedures

• MRI (subgroup of patients): Conditions contraindicating MRI including, but not limited to, BMI > 40 kg/m2, claustrophobia, metallic implants or internal electrical devices (e.g. Pacemaker).