Ignite Creation Date:
2024-07-17 @ 10:56 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06463600
Status:
RECRUITING
Last Update Posted:
2024-06-18
First Post:
2024-06-11
Brief Title:
Tumour Localisation With Magnetic Clip Before Neoadjuvant Chemotherapy
Sponsor:
Sahlgrenska University Hospital Sweden
Organization:
Sahlgrenska University Hospital Sweden
Study Overview
Official Title:
Tumour Localisation With Magnetic Clip Before Neoadjuvant Chemotherapy A Randomised Pilot Feasibility Study MagLocal 10
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MagLocal
Brief 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None