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Trial Title:
Lymph Node Identification Using Magtrace and Magseed Before Chemotherapy
NCT ID:
NCT06104371
Condition:
Breast Cancer
Conditions: Keywords:
sentinel lymph node detection
neoadjuvant chemotherapy
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Device
Intervention name:
Magtrace
Description:
Sentinel lymph node tracer and metastatic lymph node clip
Arm group label:
Node negative
Arm group label:
Node positive
Other name:
Magseed
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 identification.
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 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.
Criteria for eligibility:
Study pop:
All patients planned for preoperative chemotherapy before breast surgery.
Sampling method:
Non-Probability Sample
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
85 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Sahlgrenska University Hospital
Address:
City:
Gothenburg
Zip:
413 45
Country:
Sweden
Start date:
December 1, 2024
Completion date:
December 31, 2028
Lead sponsor:
Agency:
Vastra Gotaland Region
Agency class:
Other
Collaborator:
Agency:
Uppsala University
Agency class:
Other
Collaborator:
Agency:
Region Västmanland
Agency class:
Other
Collaborator:
Agency:
University Hospital, Linkoeping
Agency class:
Other
Collaborator:
Agency:
Baylor College of Medicine
Agency class:
Other
Collaborator:
Agency:
The University of Hong Kong-Shenzhen Hospital
Agency class:
Other
Collaborator:
Agency:
Royal Marsden NHS Foundation Trust
Agency class:
Other
Collaborator:
Agency:
University of Athens
Agency class:
Other
Collaborator:
Agency:
University College Dublin
Agency class:
Other
Source:
Vastra Gotaland Region
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06104371
