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

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

Plain Language Summary

Simplified for easier understanding

This study evaluates the CONVIVO system, a microscope-like device used during brain surgery that provides real-time imaging to help surgeons distinguish tumor tissue from normal brain tissue more precisely. **You may be eligible if...** - You are 18 or older - You are suspected to have a brain tumor (glioma, glioblastoma, brain metastasis, meningioma, acoustic neuroma, or pituitary adenoma) - You are a candidate for brain surgery - You can provide informed consent **You may NOT be eligible if...** - You are pregnant - You are under 18 - You have an allergy to fluorescein sodium (the imaging dye used) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.


Locations(1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

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NCT05139277


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