Evaluation of the CONVIVO System
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDartmouth-Hitchcock Medical Center
About 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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
Pregnancy
Children (age <18 years)
Fluorescein sodium (FNa) allergy
Trial design
Treatments tested in this trial
- CONVIVO system
- Conventional histologic evaluation
Treatment groups
30 Participants
are divided into 2 treatment groupsSponsors and collaborators
Dartmouth-Hitchcock Medical Center
Lead sponsor
Carl Zeiss Meditec, Inc.
Collaborator
Source ClinicalTrials.gov