Evaluating the CONVIVO System for Brain Tumor Surgery
Clinical Investigation to Evaluate the CONVIVO System for Discrimination of Normal From Abnormal Tissue During Brain Tumor Resection
This study is testing a new imaging tool during brain tumor surgery to see if it can better tell the difference between healthy and unhealthy brain tissue for patients with brain tumors.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Dartmouth-Hitchcock Medical Center Academic / other |
| Locations | 1 site (Lebanon, New Hampshire) |
| Trial ID | NCT05139277 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the diagnostic performance of the CONVIVO confocal endomicroscope in distinguishing between normal and abnormal brain tissue during surgical procedures for brain tumors. By comparing intraoperative images obtained with the CONVIVO system to conventional histologic evaluations of targeted biopsies, the researchers hope to establish a strong correlation between the two methods. The study focuses on patients with various types of brain tumors, including glioblastoma and meningiomas, who are candidates for surgical intervention. This innovative approach seeks to enhance the extent of tumor resection while minimizing risks associated with surgery.
Who should consider this trial
Good fit: Ideal candidates for this study are adult patients over 18 years old with suspected intracranial gliomas or other specified brain tumors who are eligible for surgery.
Not a fit: Patients who are pregnant, under 18 years old, or have an allergy to fluorescein sodium may not benefit from this study.
Why it matters
Potential benefit: If successful, this could lead to improved surgical outcomes and survival rates for patients with brain tumors.
How similar studies have performed: This approach is novel, as previous studies have not evaluated the use of confocal microscopy for real-time tissue discrimination during brain tumor surgeries.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients (age\>18) * Adults presenting with suspected intracranial gliomas (including glioblastoma), cerebral metastasis, meningiomas, acoustic neuromas, and pituitary adenomas, who are surgical candidates * Adults able to provide informed consent. Exclusion Criteria: * Pregnancy * Children (age \<18 years) * Fluorescein sodium (FNa) allergy
Where this trial is running
Lebanon, New Hampshire
- Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States (Recruiting)
Study contacts
- Principal investigator: Linton T Evans, MD — Dartmouth-Hitchcock Medical Center
- Study coordinator: Linton T Evans, MD
- Email: Linton.T.Evans@hitchcock.org
- Phone: 603-650-5026
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.