Evaluation of the CONVIVO System

NARecruitingINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

June 28, 2022

Primary Completion Date

June 30, 2025

Study Completion Date

June 30, 2025

Conditions
GlioblastomaGlial TumorBrain MetastasesMeningiomaSchwannomaPituitary 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.

Trial Locations (1)

03756

RECRUITING

Dartmouth-Hitchcock Medical Center, Lebanon

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Carl Zeiss Meditec, Inc.

INDUSTRY

lead

Dartmouth-Hitchcock Medical Center

OTHER

NCT05139277 - Evaluation of the CONVIVO System | Biotech Hunter | Biotech Hunter