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Evaluating a Prototype CT Scan for ICH Evacuation

ConditionIntracerebral Hemorrhage
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIcahn School of Medicine at Mount Sinai

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient ≥ 18 years old

Patient is planned to undergo minimally invasive hemorrhage evacuation at Mount Sinai West Hospital

Disqualifiers

Patient is < 18 years old

Patient is not planned to undergo minimally invasive hemorrhage evacuation at Mount Sinai West Hospital

Trial design

Design model

Single group

Treatments tested in this trial

  • DynaCT Multiphase

    Device

    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

    Device

    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.

Treatment groups

15 Participants
are divided into 1 treatment group
Group A: DynaCT Multiphase scanOther 2 interventions

Trial outcomes

Primary outcomes

1

Volume 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

Secondary outcomes

1

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
2

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
3

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Icahn School of Medicine at Mount Sinai

Lead sponsor

Siemens Corporation, Corporate Technology

Collaborator

Source ClinicalTrials.gov
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