Intracerebral Hemorrhage
Conditions
Keywords
Minimally invasive hemorrhage evacuation
Brief summary
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.
Detailed description
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
Interventions
DEVICEDynaCT Multiphase
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.
DEVICEDynaCT Sine Spin
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.
Sponsors
Icahn School of Medicine at Mount Sinai
Siemens Corporation, Corporate Technology
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient ≥ 18 years old * Patient is planned to undergo minimally invasive hemorrhage evacuation at Mount Sinai West Hospital
Exclusion criteria
* Patient is \< 18 years old * Patient is not planned to undergo minimally invasive hemorrhage evacuation at Mount Sinai West Hospital
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Volume of Post-procedure hemorrhage | Immediately post-procedure | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quantitative correlation outcomes of post-procedure hemorrhage | Immediately post-procedure | 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). |
| Qualitative assessment of the contours of post-procedure hemorrhage | Immediately post-procedure | 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. |
| Volume of Pre-procedure hemorrhage | Pre-procedure | 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 |
Countries
United States
Contacts
CONTACTEmily Svendsen
CONTACTSydney Edwards
PRINCIPAL_INVESTIGATORChristopher Kellner
Icahn School of Medicine at Mount Sinai
Outcome results
None listed