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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NCT05139277

Evaluation of the CONVIVO System

Recruiting
NAAges 18+InterventionalDiagnostic
Dartmouth-Hitchcock Medical Center
~30 participants
Updated 2026-02-06 on ClinicalTrials.gov
What's tested:CONVIVO systemConventional histologic evaluation

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Diagnostic performance of CONVIVO in discriminating between normal and abnormal tissue
Measured over On day of Surgery, Day 0
Glioblastoma
Glial Tumor
Brain Metastases
Meningioma
Schwannoma
Pituitary Tumor
1 sites across 1 states
New Hampshire1
  • Linton T Evans, MD · PRINCIPAL_INVESTIGATOR · Dartmouth-Hitchcock Medical Center

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Eligibility criteria

Inclusion

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

Pregnancy
Children (age \<18 years)
Fluorescein sodium (FNa) allergy
  • 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.