Ignite Creation Date:
2024-05-06 @ 7:41 AM
Last Modification Date:
2024-10-26 @ 11:51 AM
Study NCT ID:
NCT02583568
Status:
COMPLETED
Last Update Posted:
2017-02-13
First Post:
2015-06-30
Brief Title:
Fluorescence Guided Surgery in Breast Cancer
Sponsor:
University Medical Center Groningen
Organization:
University Medical Center Groningen
Study Overview
Official Title:
Phase II Open-Label Study to Evaluate Safety and Explore Efficacy of Escalating Doses of Bevacizumab-IRDye800CW as an Optical Imaging Agent to Detect Cancer Tissue Delineation During Tumor Resection Surgery in Patients With Breast Cancer
Status:
COMPLETED
Status Verified Date:
2017-02
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:
MARGIN
Brief Summary:
A need for further investigation for fluorescence image-guided surgery in breast conserving surgery BCS has arisen following the results obtained from a phase I feasibility breast cancer trial BIRDYE study ABR NL 37479042011 The aim of this study is to define the optimal dose of the fluorescent tracer Bevacizumab-IRDye800CW for intraoperative delineation of breast cancer tissue using the improved and optimized fluorescent tracer and camera system
Detailed Description:
None
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