Lymph Node Identification Using Magtrace and Magseed Before Chemotherapy
ConditionBreast Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-85
SponsorVastra Gotaland Region
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial population
All patients planned for preoperative chemotherapy before breast surgery.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Magtrace
DeviceSentinel lymph node tracer and metastatic lymph node clip
Treatment groups
459 Participants
are divided into 2 treatment groupsGroup A: Node negative1 intervention
Group B: Node positive1 intervention
Trial outcomes
Primary outcomes
1
Sentinel lymph node detection rate
per patient
Time frame
PerioperativelySecondary outcomes
1
Number of sentinel lymph nodes detected per tracer
per node
Time frame
Perioperatively2
Concordance of nodes per tracer
Ratio
Time frame
PerioperativelySponsors and contacts
Click on the lead sponsor to view all of their trials.
Vastra Gotaland Region
Lead sponsor
Sahlgrenska University Hospital
Sponsor institution
Uppsala University
Collaborator
Region Västmanland
Collaborator
University Hospital, Linkoeping
Collaborator
Baylor College of Medicine
Collaborator
The University of Hong Kong-Shenzhen Hospital
Collaborator
Royal Marsden NHS Foundation Trust
Collaborator
University of Athens
Collaborator
University College Dublin
Collaborator
Source ClinicalTrials.gov