An interventional study of 3D CEST imaging in Stroke, Acute, sponsored by King's College Hospital NHS Trust. Status unknown at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-04-05.
Sponsored by King's College Hospital NHS Trust · Not applicable, Interventional, and Diagnostic
CEST in Stroke is an observational magnetic resonance imaging (MRI) study in acute ischaemic stroke patients. Ischaemic stokes are the most common type of stroke and occur when a blood clot blocks the flow of blood and oxygen your brain needs. This can lead to cellular death (infarction) so the quicker a stroke is diagnosed and treated, the better a patient's recovery is likely to be.
The purpose of this study is to determine the technical feasibility of a new MRI technique known as Chemical Exchange Saturation Transfer (CEST) imaging for assessing the extent of potentially salvageable brain tissue (penumbra) around an area of infarction. CEST imaging works by looking at the chemicals in the brain cells. The chemicals may change when cells are affected by stroke. Stroke patients are not normally treated with with clotbusting drugs or clot-retrieving devices if they arrive at hospital many hours after the stroke because treatment may not help and in some cases it may cause more harm than good. However, the new MRI technique could detect those stroke patients who arrive at hospital many hours after the stroke but still have salvageable brain - in these cases it would be helpful to treat these patients and therefore stop those cells from dying.
However, there are several technical issues that need to be addressed before CEST can be adopted as a routine clinical assessment. CEST in Stroke hopes to address these issues by using an alternate MRI sequence capable of acquiring CEST data over a large portion of the brain in approximately in 10 minutes.
The overall aim of study is to determine the feasibility of CEST imaging for assessing the extent of penumbra, in order to determine which patients may benefit from re-perfusion interventions who would otherwise not be eligible. If the study is successful, further research will be implemented to help clinical decision making in stroke patients who present outside of conventional time windows.
CEST in Stroke is an observational magnetic resonance imaging (MRI) study in acute ischaemic stroke patients. Ischaemic stokes are the most common type of stroke and occur when a blood clot blocks the flow of blood and oxygen your brain needs. This can lead to cellular death (infarction) so the quicker a stroke is diagnosed and treated, the better a patient's recovery is likely to be.
The purpose of this study is to determine the technical feasibility of a new MRI technique known as Chemical Exchange Saturation Transfer (CEST) imaging for assessing the extent of potentially salvageable brain tissue (penumbra) around an area of infarction. CEST imaging works by looking at the chemicals in the brain cells. The chemicals may change when cells are affected by stroke. Stroke patients are not normally treated with with clotbusting drugs or clot-retrieving devices if they arrive at hospital many hours after the stroke because treatment may not help and in some cases it may cause more harm than good. However, the new MRI technique could detect those stroke patients who arrive at hospital many hours after the stroke but still have salvageable brain - in these cases it would be helpful to treat these patients and therefore stop those cells from dying.
However, there are several technical issues that need to be addressed before CEST can be adopted as a routine clinical assessment. CEST in Stroke hopes to address these issues by using an alternate MRI sequence capable of acquiring CEST data over a large portion of the brain in approximately in 10 minutes.
The overall aim of study is to determine the feasibility of CEST imaging for assessing the extent of penumbra, in order to determine which patients may benefit from re-perfusion interventions who would otherwise not be eligible. If the study is successful, further research will be implemented to help clinical decision making in stroke patients who present outside of conventional time windows.
Eligible participants (or a consultee) will be approached upon admission in A\&E or on the Hyper Acute Stroke Unit within 24 hours of onset. The study will be described in detail and an information sheet provided. After being given sufficient time to consider participation, the participant or their consultee will be asked to complete a consent form. They will be given a copy of the consent form and information sheet for their records.
A one off study visit will then take place. This will entail a 30 minute MRI scan in the King's College Hospital Clinical Research Facility. In addition, a brief neurological assessment (routine examination for all stroke patients) will also be performed and the following information collected: demographics, past medical history and any local laboratory results. The participant's clinical details will be recorded on a case report form (CRF). Any clinical information not provided by the participant will be completed using the patient's medical notes.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's planned enrollment of 28 is below the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →King's College Hospital NHS Trust is the lead sponsor of 164 studies on the registry; 54 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
CEST imaging will be performed (15 min): Axial 3D volume acquisition at 3.5 mm isotropic voxel size, 20-30 offset frequencies, plus Axial 3D T1w and T2w map at same resolution for use in CEST quantification. A routine stroke MRI protocol will also be performed (10 min): Axial T2w; Axial DWI and ADC (apparent diffusion coefficient) using accelerated multi-band sequence; Axial T2w\* or SWI (susceptibility weighted imaging); and dynamic susceptibility contrast-enhanced (DSC) perfusion imaging following contrast agent administration (5 min, provided Radiology Department protocols allow DSC (e.g. no renal impairment)).
Diagnostic Test: 3D CEST imaging
Chemical Exchange Saturation Transfer (CEST) is an emerging MRI technique that can acquire multiple endogenous contrasts to probe cerebral metabolism.
Technical feasibility of 3D CEST imaging in acute stroke: Percentage of patients where acquisition of a comprehensive raw CEST dataset can be performed over the human brain
Percentage of patients where acquisition of a comprehensive raw CEST dataset can be performed over the human brain
Time frame: Within 24 hours of ictus
Technical feasibility of 3D CEST imaging in acute stroke: Percentage of patients with quantitative maps of different CEST contrasts produced including APT, NOE, and pH-weighted
Percentage of patients with quantitative maps of different CEST contrasts produced including APT, NOE, and pH-weighted
Time frame: Within 24 hours of ictus
Technical feasibility of 3D CEST imaging in acute stroke: Signal-to-noise ratio on the CEST contrasts determined: with and without motion
Signal-to-noise ratio on the CEST contrasts determined: with and without motion
Time frame: Within 24 hours of ictus
Clinical feasibility: Number of patients recruited per month (determined at completion of study)
Number of patients recruited per month (determined at completion of study)
Time frame: Within 24 hours of ictus
Clinical feasibility: Patients tolerating full scan protocol per month
Number of patients tolerating full scan protocol per month
Time frame: Within 24 hours of ictus
Dice score of abnormality seen on CEST contrast & routine stroke sequences
CEST contrast \& perfusion imaging (including PWI-DWI mismatch)
Time frame: Within 24 hours of ictus
Plan to share: No
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King's College Hospital NHS Trust