PURPOSE: to provide proof of principle of safety, @entity0 -specific uptake and positive @entity5 margin assessment of the systemically administered near-infrared fluorescent (NIRF) tracer bevacizumab-IRDye800CW targeting @entity7 ( @entity7 )-A in @entity0 @entity1 . EXPERIMENTAL DESIGN: Twenty @entity1 with primary invasive @entity0 eligible for primary surgery received 4.5 mg bevacizumab-IRDye800CW as intravenous bolus injection. Safety aspects were assessed as well as tracer uptake and @entity5 delineation during surgery and ex vivo in surgical specimens using an optical imaging system. Ex vivo multiplexed histopathology analyses were performed for evaluation of biodistribution of tracer uptake and co-registration of @entity5 tissue and healthy tissue. RESULTS: None of the @entity1 experienced adverse events. Tracer levels in @entity5 tissue were higher compared to those in the @entity5 margin (P < 0.05) and healthy tissue (P < 0.0001). @entity7 @entity5 levels also correlated with tracer levels (r = 0.63, P < 0.0002). All but one @entity5 showed specific tracer uptake. Two out of 20 surgically excised lumps contained microscopic positive margins detected ex vivo by fluorescent macro- and microscopy and confirmed at the cellular level. CONCLUSIONS: Our study shows that systemic administration of the bevacizumab-IRDye800CW tracer is safe for @entity0 guidance and confirms @entity5 and @entity5 -margin uptake as evaluated by a systematic validation methodology. The findings are a step towards a phase II dose-finding study aimed at in vivo margin assessment and point to a novel drug assessment tool that provides a detailed picture of drug distribution in @entity5 tissue.

Tumor-specific uptake of fluorescent bevacizumab-IRDye800CW microdosing in XXXX with primary @entity0 : a phase I feasibility study.

@entity5 :: ('MESH:D009369', 'Disease') :: ['tumor', 'primary tumor'] @entity1 :: ('9606', 'Species') :: ['patients'] @entity0 :: ('MESH:D001943', 'Disease') :: ['breast cancer', 'breast tumor'] @entity7 :: ('7422', 'Gene') :: ['vascular endothelial growth factor', 'VEGF', 'VEGF-A']
@entity1 :: (9606,Species) :: ['patients']
