The aim of the project is to collect pre-procedural CT scans, intra-procedural post-evacuation scans as well as immediate post-procedural CT scans to evaluate and collect feedback of two Siemens prototypes: 1) perfusion prototype and 2) automatic hemorrhage detection prototype. The assessment of the prototypes, including its features will focus on the feasibility, usefulness as well as the potential clinical value add in minimally invasive ICH treatment.
The aim of the project is to prospectively collect pre-procedural CT scans, intraprocedural scans post-evacuation (7s DynaCT Sine Spin and DynaCT Multiphase) and immediate post-procedural CT scans to evaluate and collect feedback of two Siemens prototypes. The assessment of the prototypes, including its features, will focus on the feasibility, usefulness, and potential clinical value. In addition to the prospective data collection outlined above, already available pre- and post procedural CT data sets as well as pre- and post-evacuation DynaCT Sine Spin data sets will be collected retrospectively (n=5). These data sets were acquired as part of standard of care procedures. The additional data sets will also be included in the evaluation
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
DynaCT Multiphase device is the perfusion prototype scan. DynaCT Multiphase scans taken intra-operatively will be processed offsite on Siemens' hemorrhage detection and perfusion prototypes.
DynaCT Sine Spin scan is the automatic hemorrhage detection prototype. Scans taken intra-operatively will be processed offsite on Siemens' hemorrhage detection and perfusion prototypes.
Mount Sinai West
New York, New York, United States
RECRUITINGVolume of Post-procedure hemorrhage
Quantitative assessment of the comparison of the detected residual hemorrhage on the DynaCT Sine Spin data and the detected residual hematoma on the immediate post-procedural CT
Time frame: Immediately post-procedure
Quantitative correlation outcomes of post-procedure hemorrhage
Correlation of the generated perfusion maps (CBV, CBF, MTT, TTP) to other available clinical information. Prespecified variables to be included are; Location of hypoperfusion on FPCT-PI (1-frontal, 2-parietal, 3-temporal, 4-occipital) and presence of residual hypoperfusion on FPCT-PI (1-present, 2-absent).
Time frame: Immediately post-procedure
Qualitative assessment of the contours of post-procedure hemorrhage
Qualitative assessment of the contours on DynaCT Sine Spin vs postprocedural CT of the hemorrhage detection prototype, using the following scale for evaluation: 1=Clinically usable, 2=Usable with minor edits, 3=Usable with major edits, 4=Redo completely.
Time frame: Immediately post-procedure
Volume of Pre-procedure hemorrhage
Quantitative assessment of the comparison of the detected residual hemorrhage on the DynaCT Sine Spin data and the detected hematoma on the pre-procedural CT
Time frame: Pre-procedure
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