Clinical Investigation to Evaluate the CONVIVO System for Discrimination of Normal From Abnormal Tissue During Brain Tumor Resection

Status: Recruiting
Location: See location...
Intervention Type: Other, Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
New Hampshire
Dartmouth-Hitchcock Medical Center
RECRUITING
Lebanon
Contact Information
Primary
Linton T Evans, MD
Linton.T.Evans@hitchcock.org
603-650-5026
Time Frame
Start Date: 2022-06-28
Estimated Completion Date: 2025-06
Participants
Target number of participants: 30
Treatments
Experimental: CONVIVO system
During tumor resection, study investigators trained in the use of the system will determine when the CONVIVO imaging system will be used for in vivo¬ imaging. At this point 5 mg/kg of fluorescein will be administered intravenously by an anesthesia provider over one minute.Approximately 2-5 minutes following administration of FNa in situ imaging will be performed by the participating surgeon ensuring proper technique.
Other: Conventional histologic evaluation
Following image acquisition, the tissue region imaged with the CONVIVO system will then be biopsied using biopsy forceps. This will be passed immediately off the surgical field as a research specimen and provided to a member of the research team to be prepared for conventional histologic evaluation. The specimen will be labeled with the deidentified subject and sample number. This sequence will then be repeated for each successive sample.
Related Therapeutic Areas
Neuroendocrine Tumor
Hypothalamic Tumor
Astrocytoma
Glioblastoma
Meningioma
Schwannoma
Brain Tumor
Glioma
Pituitary Tumor
Gliomatosis Cerebri
Sponsors
Collaborators: Carl Zeiss Meditec, Inc.
Leads: Dartmouth-Hitchcock Medical Center

This content was sourced from clinicaltrials.gov

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