Evaluation of the CONVIVO System
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDartmouth-Hitchcock Medical Center
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Pregnancy
Children (age <18 years)
Fluorescein sodium (FNa) allergy
Trial design
Design model
Single group
Treatments tested in this trial
CONVIVO system
Diagnostic testApproximately 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.
Conventional histologic evaluation
Other interventionFollowing 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.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: CONVIVO systemExperimental treatment 1 intervention
Group B: Conventional histologic evaluationOther 1 intervention
Trial outcomes
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.
Time frame
On day of Surgery, Day 0Secondary outcomes
1
Degree of concordance with histologic diagnosis
Degree of concordance between in vivo imaging with the CONVIVO system and conventional histologic assessment or frozen with respect to histologic diagnosis.
Time frame
On day of surgery, Day 02
Sensitivity and Specificity of CONVIVO system
Sensitivity and specificity analysis of CONVIVO using area under the curve and receiver operating characteristics. Conventional histopathology will be the gold-standard.
Time frame
On day of surgery, Day 03
Rate of uninterpretable or non-diagnostic imaging with the CONVIVO system.
Rate of uninterpretable or non-diagnostic imaging with the CONVIVO system. During the resection the PI or other investigators may image tissue that is ultimately not biopsied. For example at the end of resection if there is a region of interest that cannot be safely resected, the CONVIVO system can be used to image the tissue without obtaining a corresponding tissue specimen for histology. During image acquisition it will be noted and documented by the research team that there is not a corresponding tissue specimen.
Time frame
On day of surgery, Day 04
Correlation between intra-operative confocal microscopy and co-registered MRI points.
MRI characteristics will include (i) the presence or absence of contrast enhancement; (ii) signal intensity on T2 weighted images; (iii) perfusion based and spectroscopy imaging; (iv) diffusion weighted sequences.
Time frame
On day of surgery, Day 0Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Dartmouth-Hitchcock Medical Center
Lead sponsor
Carl Zeiss Meditec, Inc.
Collaborator
Source ClinicalTrials.gov