Clinical Trials

Intraoperative Microdialysis During Neurosurgery for Central Nervous System Malignancies

The primary hypotheses are that the TULSA-Procedure is safe and effective treatment of intermediate grade prostate cancer over 2 years. The primary endpoint is defined as the proportion of patients who maintain urinary continence and erectile potency. The effectiveness co-primary endpoint is defined as the proportion of patients free from treatment failure.

The purpose of this study is to combine MRI images with histologic and genetic analysis of cancer (from blood and tissue samples) to improve the overall accuracy of diagnosis and effectiveness of cancer treatment.

The purpose of this study is to explore the translational abilities of desorption electrospray ionization mass spectrometry (DESI-MS) as intraoperative diagnostic tool to identify cancerous versus noncancerous tissue and estimate the percentage of tumor infiltration in tissue biopsies, by monitoring depletion of N-acetylaspartate (NAA) and aberrations of the phospholipid signature of neurological tissue; and to identify the presence of IDH mutations by monitoring the 2-hydroxyglutarate (2HG) and, therefore, differentiate between IDH-mutant and wild-type gliomas.

This is a retrospective specimen acquisition study of pre-treatment head and neck squamous cell carcinoma tumor biopsy samples.  The sponsor-provided protocol allows for multiple different tumor types.  However, Mayo Clinic, Rochester will only enroll head and neck squamous cell carcinoma.