Sahlgrenska University Hospital
Gothenburg, 413 45, Sweden
Location status: Recruiting
Location contact
Roger Olofsson Bagge, Dr
CONTACT
Roger Olofsson Bagge, Dr
PRINCIPAL_INVESTIGATOR
NCT Number: NCT06104371
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.
Interested in participating?
Request Info18 year–85 year
All sexes
Observational
Gothenburg, 413 45, Sweden
Location status: Recruiting
Roger Olofsson Bagge, Dr
CONTACT
Roger Olofsson Bagge, Dr
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Sentinel lymph node tracer and metastatic lymph node clip
Other names: Magseed
Time frame: Perioperatively
per patient
Time frame: Perioperatively
per node
Time frame: Perioperatively
Ratio
Contact information is provided by the study sponsor or research team.
Fredrik AM Warnberg, prof
CONTACT
Kian AM Chin, MD
CONTACT
Vastra Gotaland Region
Other Gov
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
Acronym: SentiNeo2
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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