RecruitingNot ApplicableNCT05139277

Evaluation of the CONVIVO System

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

Sponsor

Dartmouth-Hitchcock Medical Center

Enrollment

30 participants

Start Date

Jun 28, 2022

Study Type

INTERVENTIONAL

Conditions

Brain Metastases Glioblastoma Meningioma Pituitary Tumor Schwannoma Glial Tumor

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

Min Age: 18 Years

Inclusion Criteria3

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.

Exclusion Criteria3

Pregnancy
Children (age \<18 years)
Fluorescein sodium (FNa) allergy

Interventions

DIAGNOSTIC_TESTCONVIVO system

Approximately 2-5 minutes following administration of FNa in situ imaging will be performed by the participating surgeon ensuring proper technique. Prior to entering the surgical field, the probe will be covered in a disposable sterile sheath that is manufactured with quality assurance for this purpose. The probe will gently be held against the tissue interface while imaging occurs. Again this will only be in regions that would normally be resected or sampled in routine clinical care. Following image acquisition, a neuropathologist present in the operating room, will review and capture each image.

OTHERConventional 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.