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Trial Title:
Tumour Localisation With Magnetic Clip Before Neoadjuvant Chemotherapy.
NCT ID:
NCT06463600
Condition:
Breast Conserving Surgery
Conditions: Keywords:
Breast cancer
Tumour localisation
Magnetic clip
magnetic tracer
Preoperative chemotherapy
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
One part feasibility and one part randomised.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
Magseed
Description:
Tumour localizer
Arm group label:
Tumour localisation with Magseed
Intervention type:
Device
Intervention name:
Metallic clip and guide wire
Description:
Tumour localizers
Arm group label:
Metallic marker + guide wire
Summary:
The feasibility of the use of magnetic clips for tumour localisation before preoperative
chemotherapy in combination with superparamagnetic iron oxide nanoparticles (SPIO) as
tracer for sentinel lymph node (SLN) detection and in combination with a magnetic clip in
the index lymph node metastasis is studied.
Detailed description:
The overall aim is to demonstrate that the use of magnetic clips for tumour localisation
before preoperative chemotherapy is feasible at breast cancer surgery and
histopathological evaluation in combination with superparamagnetic iron oxide
nanoparticles (SPIO) as tracer for sentinel lymph node (SLN) detection, and in
combination with a magnetic clip in the index lymph node metastasis if targeted axillary
surgery is planned.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age above 18 years
2. Planned for preoperative chemotherapy before breast cancer surgery
3. Planned breast conserving surgery with targeted axillary dissection or sentinel
lymph node biopsy using magnetic technique
4. SLN-biopsy with magnetic tracer or targeted axillary dissection using magnetic
tracer and Magseed
5. Signed and dated written informed consent before the start of specific protocol
procedures
Exclusion Criteria:
1. Pregnant or breast-feeding
2. Iron overload disease
3. Known hypersensitivity to iron or dextran compounds
4. Inability to understand given information and give informed consent or undergo study
procedures
5. Planned MRI control for tumour response during chemotherapy
Gender:
Female
Gender based:
Yes
Gender description:
Breast conserving surgery
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Sahlgrenska Academy at Gothenburg University
Address:
City:
Gothenburg
Zip:
41345
Country:
Sweden
Status:
Recruiting
Contact:
Last name:
Fredrik Warnberg, prof
Phone:
+46706146251
Email:
fredrik.warnberg@vgregion.se
Contact backup:
Last name:
Kian Chin, MD
Phone:
+46702316011
Email:
kian.chin@vgregion.se
Start date:
February 1, 2024
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Sahlgrenska University Hospital, Sweden
Agency class:
Other
Source:
Sahlgrenska University Hospital, Sweden
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06463600
