Evaluation of the CONVIVO System

NCT05139277 | Recruiting FDA Device

• 2 other identifiers: D20056NCI-2023-06342
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Diagnostic performance of CONVIVO in discriminating between normal and abnormal tissue

  Concordance between in vivo imaging with the CONVIVO system and conventional histologic assessment.The diagnostic performance of the CONVIVO system will be assessed with respect to classification as "normal" or "abnormal" tissue. The interpretation of intraoperative images obtained in situ will be tested against conventional histologic evaluation of targeted biopsies from imaged tissue. Pertinent tumors include all intracranial neoplasms including low and high grade glial neoplasms, glioneuronal tumors, cerebral metastasis, meningioma, schwannoma, and pituitary lesions.

  On day of Surgery, Day 0

Secondary Outcomes (10)

• Degree of concordance with histologic diagnosis

  On day of surgery, Day 0

• Sensitivity and Specificity of CONVIVO system

  On day of surgery, Day 0

• Rate of uninterpretable or non-diagnostic imaging with the CONVIVO system.

  On day of surgery, Day 0

• Correlation between intra-operative confocal microscopy and co-registered MRI points.

  On day of surgery, Day 0

• Correlation between visible yellow-light fluorescence (560 nm filter) and intraoperative confocal microscopy.

  On day of surgery, Day 0

Study Arms (2)

CONVIVO system

EXPERIMENTAL

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.

Diagnostic Test: CONVIVO system

Conventional histologic evaluation

OTHER

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.

Other: Conventional histologic evaluation

Interventions

CONVIVO system DIAGNOSTIC_TEST

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.

CONVIVO system

Conventional histologic evaluation OTHER

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.

Conventional histologic evaluation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead
• Carl Zeiss Meditec, Inc.: collaborator

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

RECRUITING

MeSH Terms

Conditions

Glioblastoma; Glioma; Brain Neoplasms; Meningioma; Neurilemmoma; Pituitary Neoplasms

Condition Hierarchy (Ancestors)

Astrocytoma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms, Vascular Tissue; Meningeal Neoplasms; Neuroendocrine Tumors; Neuroma; Nerve Sheath Neoplasms; Endocrine Gland Neoplasms; Hypothalamic Neoplasms; Supratentorial Neoplasms; Hypothalamic Diseases; Pituitary Diseases; Endocrine System Diseases

Study Officials

• Linton T Evans, MD

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Linton T Evans, MD

CONTACT

603-650-5026; Linton.T.Evans@hitchcock.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: Adult patients (age\>18) presenting with suspected intracranial gliomas (including glioblastoma), cerebral metastasis, meningiomas, acoustic neuromas, and pituitary adenomas, who are surgical candidates and provide informed consent.

Study Record Dates

• First Submitted: November 4, 2021
• First Posted: December 1, 2021
• Study Start: June 28, 2022
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: February 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)