Real-time imaging during brain tumor surgery
A Feasibility Analysis of an in Vivo CONVIVO Endomicroscopy During Brain Surgery.
This study tests a new handheld imaging tool during brain tumor surgery to see if it helps doctors better tell the difference between healthy and tumor tissue in patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Sex | All |
| Sponsor | Northwell Health Academic / other |
| Locations | 1 site (Manhasset, New York) |
| Trial ID | NCT06087393 on ClinicalTrials.gov |
What this trial studies
This project investigates the use of the CONVIVO system, a handheld imaging technology that provides real-time digital images of tissue microstructure during neurosurgery. The goal is to improve the surgical treatment of brain tumors by allowing surgeons to distinguish between healthy and abnormal tissues more effectively. By enabling intraoperative visualization at cellular resolution, this method aims to optimize biopsy procedures and enhance the accuracy of tumor resections. The study will involve 30 patients diagnosed with intrinsic brain tumors to assess the ease of use and effectiveness of this technology.
Who should consider this trial
Good fit: Ideal candidates for this study are patients undergoing elective neurosurgical resection for high-grade invasive brain tumors.
Not a fit: Patients with hypersensitivity to fluorescein, renal failure, or those who are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this technology could significantly improve surgical outcomes for patients with brain tumors by enhancing the accuracy of tumor margin identification.
How similar studies have performed: While the use of real-time imaging in surgery is a growing field, this specific application of the CONVIVO system for brain tumors is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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 women * Patients with inability to give informed consent
Where this trial is running
Manhasset, New York
- Northwell Health — Manhasset, New York, United States (Recruiting)
Study contacts
- Study coordinator: Betsy Moclair
- Email: bmoclair@northwell.edu
- Phone: 5162537753
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.