Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06610539
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-20
Brief Title:
PAS 1ml Magtrace for Sentinel Lymph Node Biopsy in Breast Cancer Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Prospective Open Label Study of Patient Reported Outcome Measures and Efficacy Following the Use of 1ml Magtrace for Sentinel Lymph Node Biopsy in Breast Cancer Patients Undergoing Lumpectomy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MAGProm
Brief Summary:
The purpose of this study is to provide prospective evidence in the US population of the frequency of skin discoloration and Sentinel Lymph Node detection rate in patients who have recevied Magtrace for Sentinel Lymph Node Biopsy SLNB and to evaluate the impact that skin discoloration has on patients when it does occur using patient reported outcome measures
Detailed Description:
The purpose of this study is to provide prospective evidence in the US population of the frequency of skin discoloration and Sentinel Lymph Node SLN detection rate in patients who have received 1ml Magtrace for Sentinel Lymph Node Biopsy SLNB and to evaluate the impact that skin discoloration has on patients when it does occur using patient reported outcome measures utilising BREAST-Q
Baseline assessment using BREAST-Q will performed A key secondary objective is to demonstrate non-inferiority of sentinel lymph node SLN detection rate with Magtrace compared to the American Society of Breast Surgeons ASBRS performance standards
All participants will undergo lymph node mapping with Magtrace and Sentinel Lymph Node Biopsy undertaken and nodes localised with the Sentimag system A sentimag count will be recorded for each node removed
After completion of the surgery at the postoperative visit the presence of Magtrace related discoloration will be assessed by the Investigator Participants found to have no Magtrace related discoloration will be asked to complete the Post-Op BREAST-Q assessment and return at 12 months post-op for a follow-up visit Those patients assessed as having the presence of Magtrace related skin discoloration will be asked complete the post-op BREAST-Q and will then undergo assessment of the size and severity of the discoloration They will then be asked to return at 6 12 18 and 24 months for follow-up visits or until the discoloration has resolved At each of these visits the BREAST-Q will be completed and the size and severity assessment will be performed
Baseline assessment using BREAST-Q will performed A key secondary objective is to demonstrate non-inferiority of sentinel lymph node SLN detection rate with Magtrace compared to the American Society of Breast Surgeons ASBRS performance standards
All participants will undergo lymph node mapping with Magtrace and Sentinel Lymph Node Biopsy undertaken and nodes localised with the Sentimag system A sentimag count will be recorded for each node removed
After completion of the surgery at the postoperative visit the presence of Magtrace related discoloration will be assessed by the Investigator Participants found to have no Magtrace related discoloration will be asked to complete the Post-Op BREAST-Q assessment and return at 12 months post-op for a follow-up visit Those patients assessed as having the presence of Magtrace related skin discoloration will be asked complete the post-op BREAST-Q and will then undergo assessment of the size and severity of the discoloration They will then be asked to return at 6 12 18 and 24 months for follow-up visits or until the discoloration has resolved At each of these visits the BREAST-Q will be completed and the size and severity assessment will be performed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None