Study of the CONVIVO Confocal Endomicroscope to Differentiate Normal and Abnormal Brain Tissue During Tumor Surgery

What this Trial Is About

Researchers are evaluating the CONVIVO confocal endomicroscope to see how well it can distinguish between normal and abnormal brain tissue during tumor surgery. This study aims to compare images taken during surgery with the standard histologic examination of biopsy samples to check how closely they match. The study focuses on brain tumors such as gliomas, metastases, meningiomas, schwannomas, and pituitary tumors in adult surgical patients. During surgery, the CONVIVO system is used after an intravenous injection of fluorescein sodium dye, which helps with fluorescence imaging. The surgeon obtains in vivo images of the tissue using a sterile-covered probe. After imaging, the same tissue area is biopsied and sent for conventional histologic analysis. The study does not use the imaging results to guide surgery and only samples tissue planned for removal. This procedure is repeated for each tissue sample. Participants will undergo imaging and biopsy during their surgery, with images and tissue samples collected for diagnostic comparison. The research team will measure the accuracy of the CONVIVO system in identifying abnormal tissue compared to standard histology, including sensitivity, specificity, and image interpretation times. They will also assess correlations with MRI and fluorescence data, extent of tumor removal, and any side effects from the dye. Participation involves only the surgical procedure and associated evaluations, with privacy protections and the option to withdraw at any time.

Evaluation of the CONVIVO System