Evaluating the CONVIVO System During Brain Tumor Surgery
This study is testing a new tool called the CONVIVO system during brain tumor surgery. The goal is to see how well the CONVIVO system can tell the difference between normal and abnormal (cancerous) tissue right when you are having surgery. Researchers will compare images from the CONVIVO system with standard tissue evaluations done by pathologists (doctors who study diseases). This study is for adults aged 18 and older who are having surgery for certain brain tumors like glioblastoma, brain metastases, or meningioma. You cannot join if you are pregnant or allergic to fluorescein sodium (FNa). The study aims to enroll 30 participants, but its current recruitment status is unclear.
- Study design
- This interventional study plans to enroll 30 adult participants. It is designed to compare the CONVIVO system's images with conventional tissue evaluations.
- What's involved
- During your brain tumor surgery, the CONVIVO system will be used for 2-5 minutes after a substance called FNa is given. Afterward, a small tissue sample will be taken from the imaged area for standard evaluation.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary outcome, diagnostic performance, is measured on the day of surgery (Day 0).
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Evaluation of the CONVIVO System
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Linton T Evans, MD · PRINCIPAL_INVESTIGATOR · Dartmouth-Hitchcock Medical Center
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Diagnostic performance of CONVIVO in discriminating between normal and abnormal tissueOn day of Surgery, Day 0
Concordance between in vivo imaging with the CONVIVO system and conventional histologic assessment.The diagnostic performance of the CONVIVO system will be assessed with respect to classification as "normal" or "abnormal" tissue. The interpretation of intraoperative images obtained in situ will be tested against conventional histologic evaluation of targeted biopsies from imaged tissue. Pertinent tumors include all intracranial neoplasms including low and high grade glial neoplasms, glioneuronal tumors, cerebral metastasis, meningioma, schwannoma, and pituitary lesions.