CONVIVO System for Brain Tumor Detection
What You Need to Know Before You Apply
What is the purpose of this trial?
The primary objective of this study is to evaluate the diagnostic performance of the CONVIVO confocal endomicroscope in discriminating between normal and abnormal tissue in vivo during brain tumor surgery. The interpretation of intraoperative images obtained in situ will be tested against conventional histologic evaluation of targeted biopsies from imaged tissue. The study team hypothesize that there will be a high degree of correlation between images obtained with the CONVIVO system and conventional histologic interpretation.
Do I need to stop my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.
Is the CONVIVO System safe for use in humans?
The CONVIVO System, a type of confocal endomicroscope, has been used in studies for brain tumor surgeries and is considered promising for providing real-time images during operations. While specific safety data is not detailed, the technology is non-invasive and has been used in clinical settings, suggesting it is generally safe for human use.12345
How is the CONVIVO System treatment different from other brain tumor treatments?
The CONVIVO System is unique because it uses confocal laser endomicroscopy to provide near real-time, high-resolution images of brain tissue during surgery, helping surgeons identify tumor margins more accurately. This technology allows for immediate intraoperative diagnosis, which is not possible with traditional methods that rely on slower histopathological analysis.12346
What data supports the effectiveness of the CONVIVO System for brain tumor detection?
Who Is on the Research Team?
Linton T Evans, MD
Principal Investigator
Dartmouth-Hitchcock Medical Center
Are You a Good Fit for This Trial?
This trial is for adults over 18 with suspected brain tumors like gliomas, meningiomas, and pituitary adenomas who can undergo surgery. It's not for pregnant individuals, children under 18, or those allergic to Fluorescein sodium.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Surgery and Imaging
During tumor resection, the CONVIVO system is used for in vivo imaging following administration of fluorescein. Images are compared to conventional histologic specimens.
Postoperative Monitoring
Postoperative MRI is obtained to assess the extent of tumor resection and monitor for adverse events related to fluorescein administration.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including interpretation of imaging and histology.
What Are the Treatments Tested in This Trial?
Interventions
- Conventional Histologic Evaluation
- CONVIVO System
CONVIVO System is already approved in United States for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Dartmouth-Hitchcock Medical Center
Lead Sponsor
Carl Zeiss Meditec, Inc.
Industry Sponsor