Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
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 |
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. |
On day of surgery, Day 0 |
|
Secondary |
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. |
On day of surgery, Day 0 |
|
Secondary |
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. |
On day of surgery, Day 0 |
|
Secondary |
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. |
On day of surgery, Day 0 |
|
Secondary |
Correlation between visible yellow-light fluorescence (560 nm filter) and intraoperative confocal microscopy. |
Following image coregistration, the 560 yellow light filter on the Kinevo microscope will be used to determine the visible fluorescence in the region that was interrogated and classified from 0 to 4 based upon the fluorescence intensity. This will be recorded by the research team. The degree of visible fluorescence will be graded as 0-no fluorescence, 1- weak intensity, 2-moderate intensity, 3-strong intensity. |
On day of surgery, Day 0 |
|
Secondary |
Correlation between visible blue-light fluorescence and quantitative fluorescence measurements |
If the participant has also received 5-ALA, the 400 nm blue light filter will then be selected and the visible fluorescence of PPIX will also be classified from 0 to 4 based upon the fluorescence intensity. The degree of visible fluorescence will be graded as 0-no fluorescence, 1- weak intensity, 2- moderate intensity, 3-strong intensity. |
On day of surgery, Day 0 |
|
Secondary |
Extent of tumor resection |
Extent of resection has been found to be associated with increased overall and progression free survival, with the greatest benefit occurring in the setting of a complete or gross total resection. Postoperative MRI is obtained as appropriate, as it relates to extent of resection. |
2 Days after surgery up to one month. |
|
Secondary |
Adverse events related to the administration of fluorescein |
Record adverse events as reported by participant or observed by investigator related to the administration of fluorescein |
Day of surgery (Day 0), 2 Days after surgery up to one month. |
|
Secondary |
Time to interpretation of imaging and histology |
Time to pathologic interpretation of intraoperative imaging compared to conventional interpretation of histology.Currently, the frozen section provides intraoperative histopathological analysis of brain tumors. Though useful, this process is time consuming and requires the cutting, freezing, and staining of several biopsies. |
Day of surgery (Day 0), and up to one week |
|
Secondary |
Ability to discriminate between viable tumor and pseudoprogression or "treatment effect" using the CONVIVO system. |
The WHO criteria for the diagnosis of Glioblastoma (GBM) - cell density, cellular pleomorphism, increased mitoses, microvascular proliferation and trpalisading or ischemic necrosis - were all detectable by Confocal EndoMicroscope (CEM). Identification of the infiltration zone or the center of the tumor was possible based upon assessments of cell density comparing the center and border specimens. Additional aspects, e.g. apoptotic figures in perinecrotic pseudopalisading tumor cells, and important histological structures such as giant cells, fibrillary tumor matrix and blood vessels were also visible with CEM. Typical features of CEM in patients with histologically proven meningioma were also seen. |
Day of surgery (Day 0) and up to one month |
|