Clinical trial · Interventional
CONVIVO System to Discriminate Healthy Tissues vs Tumor Tissues During Brain Tumor Resection
Clinical Investigation to Evaluate the CONVIVO System for Discrimination of Normal Tissues From Abnormal Tissues During Brain Tumor Resection
NCT05247749CI-TRIAL-00056637withdrawnN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Regulatory
Summary
Brief summary (as posted)
The purpose of the study is to do a direct comparison of the CONVIVO system (camera imaging device) with our normal Stanford pathology process. CONVIVO system is being tested to see if the device creates the images very quickly by touching a special camera to the surgical wound.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Tumor | Brain Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CONVIVO Confocal Endomicroscopy System | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Convivo Imaging
- description
- The brain area that the operating surgeon plans to resect will be scanned using the CONVIVO device
- interventionNames
- Device: CONVIVO Confocal Endomicroscopy System
Primary outcomes (1)
- measure
- Feasibility of using the CONVIVO imaging system to identify tumor tissue identified by the operating surgeon
- timeFrame
- 12 months
- description
- Feasibility is defined as a match between the pathologist determination of a mock diagnosis of type of tumor using CONVIVO images of the planned resection area and the pathologist's cryosection-derived diagnosis used in the course of surgery. This outcome will be expressed as a number without dispersion.
Secondary outcomes (2)
- measure
- Average time needed for tissue visualization with the CONVIVO system as compared to standard cryosectioning
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * The subject demonstrates the ability to understand and the willingness to sign a written informed consent document. * The subject is suspected to be suffering from following brain tumor: low-grade glioma, high grade-glioma, metastases, or meningioma. * The subject has been deemed eligible for surgical resection by a practicing Stanford physician. * Macroscopic tumor visualization using IV infusion of 500mg sodium fluorescein is planned as part of the subject's standard of care treatment. * The subject is older than 18 years. * The subject is receiving their surgery at Stanford Hospital. Exclusion Criteria: \* Patients with any kind of contraindication to the use of fluorescein
References
Publications (0)
Data not yet available
No reference posted for this study.