BACKGROUND: Moderate diagnostic accuracy of MRI and initial cerebrospinal fluid (CSF) cytology analysis results in at least 10%-15% false negative diagnoses of leptomeningeal metastases (LM) of solid @entity5 , thus postponing start of therapy. The aim of this prospective clinical study was to determine the diagnostic value of @entity5960 ( @entity5960 )-based flow cytometry versus cytology in CSF for the diagnosis of LM in @entity1 with @entity5 . METHODS: @entity1 with a clinical suspicion of LM but a negative or inconclusive MRI in whom a diagnostic lumbar puncture has to be performed were included. At least 5 mL of CSF for cytology, 5 mL for flow cytometry, 2 mL for cell count and biochemistry, and 8 mL whole blood samples for circulating @entity5 cells measurements and biochemistry were drawn. @entity5 cells in CSF and whole blood were detected by multiparameter flow cytometry using @entity5960 antibody. RESULTS: In total 29 eligible @entity1 were enrolled in the study. Thirteen @entity1 were ultimately diagnosed with LM. The flow cytometry assay showed 100% sensitivity and 100% specificity for diagnosing LM, while sensitivity of CSF cytology was only 61.5%. Cell count or biochemical parameters in CSF were abnormal in 100% of @entity1 with LM. CONCLUSIONS: Our results suggest that the @entity5960 -based flow cytometry assay is superior to CSF cytology for the diagnosis of LM in @entity1 with an @entity5 , a clinical suspicion of LM, and a nonconclusive MRI. Confirmation of these data is needed in a larger dataset to recommend dual CSF diagnostics for LM. CLINICALTRIALSGOV IDENTIFIER: NCT01713699.

@entity5960 -based flow cytometry in cerebrospinal fluid greatly improves diagnostic accuracy of leptomeningeal metastases from XXXX .

@entity5 :: ('MESH:D009369', 'Disease') :: ['tumor', 'Tumor', 'epithelial tumors', 'epithelial tumor', 'tumors'] @entity1 :: ('9606', 'Species') :: ['Patients', 'patients'] @entity5960 :: ('4072', 'Gene') :: ['epithelial cell adhesion molecule', 'EpCAM']
@entity5 :: (MESH:D009369,Disease) :: ['epithelial tumors']
