A Feasibility Analysis of an in Vivo CONVIVO Endomicroscopy During Brain Surgery.
Northwell Health
Summary
Visualization of the tissue microstructure during neurosurgery using a non destructive handheld imaging technology producing a real time digital image ("optical biopsy") at cellular resolution is a novel method that holds great promise for optimization and improvement of the surgical treatment of brain pathologies, brain tumors in particular. The goal of this project is to investigate and assess the ease of use of the CONVIVO FDA cleared system in discriminating healthy and abnormal tissues during in vivo use on the brain during neurosurgery in 30 patients with a working diagnosis of intrinsic brain tumors.
Description
During surgery for the removal of brain tumors, frozen-section biopsies are routinely taken intraoperatively to help the surgeon to distinguish abnormal tissue areas from normal tissue, and to assess and guide the extent of tumor or mass resection. Frozen-section analysis is time-consuming and freezing may produce architectural artifacts in the tissue sample that are difficult to interpret. As well, some tumors are heterogeneous in cell composition, so a tissue biopsy in one area may not represent the entire tumor mass. Biopsies acquired at the border regions or margins of the surgical resecti…
Eligibility
- Age range
- Not specified
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * . The patient is suffering from an intracranial lesion requiring surgery: * Patients undergoing neurosurgical resection for intrinsic presumably high grade, invasive tumors. * Patients undergoing neurosurgical resection for other brain tumors,. * All patient groups will only be comprised of elective surgical patients who have signed the informed consent prior to use Exclusion Criteria: * History of hypersensitivity to fluorescein * History of allergy or bronchial asthma * Renal failure - Children (patients less than 18 years of age) * Pregnant women * Breast feeding wo…
Interventions
- DeviceCONVIVO
Any clinical adverse event (AE), laboratory abnormality, or other medical condition or situation occurs such that continued participation in the study would not be in the best interest of the participant. The participant meets an exclusion criterion (either newly developed or not previously recognized) that precludes further study participation.
Location
- Northwell HealthManhasset, New York