Evaluation of the CONVIVO System

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.

Conditions

• Glioblastoma
• Glial Tumor
• Brain Metastases
• Meningioma
• Schwannoma
• Pituitary Tumor

Interventions

DIAGNOSTIC_TEST

CONVIVO 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.

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.

Sponsors & Collaborators

• Carl Zeiss Meditec, Inc.

  collaborator INDUSTRY

• Dartmouth-Hitchcock Medical Center

  lead OTHER

Principal Investigators

• Linton T Evans, MD · Dartmouth-Hitchcock Medical Center

Study Design

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-06-28

Primary Completion

2026-10-31

Completion

2026-10-31

FDA Device

Yes

Countries

• United States

Study Locations