CTNI-02 - A Longitudinal Therapy Response Monitoring Study in Subjects with Leptomeningeal Metastases using CNSide Compared to Standard of Care (CSF Cytology, Clinical Evaluation, Imaging)

LM is diagnosed via clinical evaluation, neuroaxis neuroimaging (MRI brain and spine), and CSF cytology. These methods have limited sensitivity and specificity, and lack the ability to quantitatively measure the LM’s response to treatment. These hindrances create challenges in LM diagnosis and management for physicians. CNSide is a commercially available Laboratory Developed Test (LDT) that is analytically validated for the detection and characterization of tumor cells in the CSF, and run commercially in Biocept’s CLIA-certified, CAP-accredited laboratory. Physicians order CNSide testing at their discretion for patients that have a suspicion of LM. To evaluate the performance of CNSide for LM disease management in a controlled setting, Biocept is conducting a prospective, multi-center clinical study (FORESEE, NCT05414123) involving patients previously diagnosed with NSCLC or Breast Cancer and a suspicion or diagnosis of LM per standard of care (SOC) management, including clinical assessment, radiographic evaluation, and CSF cytology. At baseline and at designated time points throughout treatment, matched CSF samples will be analyzed in parallel with standard of care CSF cytology and CNSide at Biocept along with time matched neuroimaging and clinical evaluation. The primary end point of the trial is the proportion of decision points during LM treatment in which physicians indicated that CNSide aided in their decision making. Physicians will also indicate which component of the test aided in management, modeling other similar studies that measure the effect of serum biomarker results on clinical management of cancer. Secondary end points include diagnostic comparison to clinical evaluation, cytology, and radiographic results, and determining the sensitivity, specificity, PPV and NPV of CNSide in the detection of CSF tumor cells (cytology being the reference standard).