Actively Recruiting
Clinical Investigation to Evaluate the CONVIVO System for Discrimination of Normal From Abnormal Tissue During Brain Tumor Resection
Led by Dartmouth-Hitchcock Medical Center · Updated on 2026-02-06
30
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
D
Dartmouth-Hitchcock Medical Center
Lead Sponsor
C
Carl Zeiss Meditec, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the CONVIVO confocal endomicroscope to see how well it can distinguish between normal and abnormal brain tissue during tumor surgery. This study aims to compare images taken during surgery with the standard histologic examination of biopsy samples to check how closely they match. The study focuses on brain tumors such as gliomas, metastases, meningiomas, schwannomas, and pituitary tumors in adult surgical patients. During surgery, the CONVIVO system is used after an intravenous injection of fluorescein sodium dye, which helps with fluorescence imaging. The surgeon obtains in vivo images of the tissue using a sterile-covered probe. After imaging, the same tissue area is biopsied and sent for conventional histologic analysis. The study does not use the imaging results to guide surgery and only samples tissue planned for removal. This procedure is repeated for each tissue sample. Participants will undergo imaging and biopsy during their surgery, with images and tissue samples collected for diagnostic comparison. The research team will measure the accuracy of the CONVIVO system in identifying abnormal tissue compared to standard histology, including sensitivity, specificity, and image interpretation times. They will also assess correlations with MRI and fluorescence data, extent of tumor removal, and any side effects from the dye. Participation involves only the surgical procedure and associated evaluations, with privacy protections and the option to withdraw at any time.
CONDITIONS
Brief Title
Evaluation of the CONVIVO System
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
You will not qualify if you...
- Pregnancy
- Children (age <18 years)
- Fluorescein sodium (FNa) allergy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of Surgery (Day 0)
Participants undergo surgical tumor resection during which the CONVIVO imaging system is used to image tissue in vivo following administration of fluorescein. Tissue samples imaged with the CONVIVO system are biopsied for conventional histologic evaluation. Imaging and biopsy procedures occur only in tissue areas already planned for resection as part of routine clinical care.
1 surgical visit (in-person)
Duration - 2 days after surgery up to one month
Participants are monitored after surgery to assess extent of tumor resection, adverse events related to fluorescein administration, and diagnostic outcomes up to one month after surgery.
Follow-up visits as part of routine clinical care
Trial Site Locations
Total: 1 location
1
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
Actively Recruiting
Research Team
L
Linton T Evans, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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