UNASSIGNED: OBJECT There is evidence that @entity2518 ( @entity6053 ) facilitates greater extent of resection and improves 6-month progression-free survival in @entity1 with high-grade @entity11 . But there remains a paucity of studies that have examined whether the intensity of @entity6053 fluorescence correlates with @entity5 cellularity. Therefore, a Phase II clinical trial was undertaken to examine the correlation of intensity of @entity6053 fluorescence with the degree of @entity5 cellularity. METHODS A single-center, prospective, single-arm, open-label Phase II clinical trial of @entity6053 fluorescence-guided resection of high-grade @entity11 (Grade III and IV) was held over a 43-month period (August 2010 to February 2014). @entity6053 was administered at a dose of 20 mg/kg body weight. Intraoperative biopsies from resection cavities were collected. The biopsies were graded on a 4-point scale (0 to 3) based on @entity6053 fluorescence intensity by the surgeon and independently based on @entity5 cellularity by a neuropathologist. The primary outcome of interest was the correlation of @entity6053 fluorescence intensity to @entity5 cellularity. The secondary outcome of interest was @entity6053 adverse events. Sensitivities, specificities, positive predictive values (PPVs), negative predictive values (NPVs), and Spearman correlation coefficients were calculated. RESULTS A total of 211 biopsies from 59 @entity1 were included. Mean age was 53.3 years and 59.5% were male. The majority of biopsies were @entity463 ( @entity463 ) (79.7%). Slightly more than half (52.5%) of all @entity5 were recurrent. @entity6053 intensity of 3 correlated with presence of @entity5 97.4% ( @entity2286 ) of the time. However, absence of @entity6053 fluorescence (intensity 0) correlated with the absence of @entity5 only 37.7% (NPV) of the time. For all @entity5 types, @entity463 , @entity11 , and recurrent @entity5 , @entity6053 intensity 3 correlated strongly with cellularity Grade 3; Spearman correlation coefficients (r) were 0.65, 0.66, 0.65, and 0.62, respectively. The specificity and @entity2286 of @entity6053 intensity 3 correlating with cellularity Grade 3 ranged from 95% to 100% and 86% to 100%, respectively. In biopsies without @entity5 (cellularity Grade 0), 35.4% still demonstrated @entity6053 fluorescence. Of those biopsies, 90.9% contained abnormal brain tissue, characterized by reactive astrocytes, scattered atypical cells, or @entity32 , and 8.1% had normal brain. In nonfluorescent ( @entity6053 intensity 0) biopsies, 62.3% had @entity5 cells present. The @entity6053 -associated complication rate among the study cohort was 3.4%. CONCLUSIONS The @entity2286 of utilizing the most robust @entity6053 fluorescence intensity (lava-like orange) as a predictor of @entity5 presence is high. However, the NPV of utilizing the absence of fluorescence as an indicator of no @entity5 is poor. @entity6053 intensity is a strong predictor for degree of @entity5 cellularity for the most fluorescent areas but less so for lower @entity6053 intensities. Even in the absence of @entity5 cells, reactive changes may lead to @entity6053 fluorescence.

A prospective Phase II clinical trial of XXXX to assess the correlation of intraoperative fluorescence intensity and degree of histologic cellularity during resection of high-grade @entity11 .

@entity1 :: ('9606', 'Species') :: ['patients'] @entity32 :: ('MESH:D007249', 'Disease') :: ['inflammation'] @entity5 :: ('MESH:D009369', 'Disease') :: ['tumor', 'tumors'] @entity2286 :: ('12211', 'Species') :: ['PPV'] @entity11 :: ('MESH:D005910', 'Disease') :: ['Grade III gliomas', 'gliomas'] @entity2518 :: ('CHEBI:17549', 'Chemical') :: ['5-aminolevulinic acid'] @entity463 :: ('MESH:D005909', 'Disease') :: ['GBM', 'glioblastoma'] @entity6053 :: ('CHEBI:27432', 'Chemical') :: ['ALA']
@entity2518 :: (CHEBI:17549,Chemical) :: ['5-aminolevulinic acid']
