Stroke, AcuteNCT04282330
Optimising 3D pH-Weighted CEST MRI in Acute Ischaemic Stroke (CEST in Stroke)
A study testing 3D CEST imaging in people with Stroke, Acute, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Acute
- What is being tested?
- 3D CEST imaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 13 Jun 2018to 30 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of acute anterior circulation ischaemic stroke
- Within 24 hours of symptom onset as defined by time since last known well
- Measurable neurological deficit (i.e. impairment of one or more of the following: language, motor function, cognition, gaze, vision, neglect)
- National Institutes of Health Stroke Scale (NIHSS) score of >= 10
- >= 18 years old
- Written informed consent from patient, legal representative or consultee
Who cannot join
- Any contraindication to MRI (e.g. cardiac pacemaker)
- Clinical diagnosis of posterior circulation ischaemic stroke
- NIHSS <10
- Evidence of intracranial haemorrhage or significant non-stroke intracranial pathology (including CNS [central nervous system] neoplasm) on CT
- Seizure at onset of symptoms unless CT identifies positive evidence of significant brain ischaemia (e.g. arterial occlusion, early ischaemic change)
- Planned or anticipated intravenous thrombolysis or endovascular re-perfusion strategies
- Pregnancy
- Known allergy to MRI contrast agent
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
King's College Hospital
London, SE5 9RS
Jonnie Aeron-Thomas, MSc, 0203 299 900 ext. 7506, j.aeron-thomas@nhs.net
About this study
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Stroke, Acute
- Being tested
- 3D CEST imaging
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D CEST imagingDiagnostic test
Chemical Exchange Saturation Transfer (CEST) is an emerging MRI technique that can acquire multiple endogenous contrasts to probe cerebral metabolism.
| Study group | Role | What they receive |
|---|---|---|
| CEST imaging performed | Other | 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)). Receives: Diagnostic Test: 3D CEST imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: Within 24 hours of ictus
Secondary outcomes (3)
Clinical feasibility: Number of patients recruited per month (determined at completion of study)
Number of patients recruited per month (determined at completion of study)
Measured: Within 24 hours of ictus
Clinical feasibility: Patients tolerating full scan protocol per month
Number of patients tolerating full scan protocol per month
Measured: Within 24 hours of ictus
Dice score of abnormality seen on CEST contrast & routine stroke sequences
CEST contrast \& perfusion imaging (including PWI-DWI mismatch)
Measured: Within 24 hours of ictus
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2020
- Study start13 Jun 2018
- Primary completion30 Apr 2023 (estimated)
- Study completion30 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, AcuteStudies of the same condition, open and under way.
- More trials run by King's College Hospital NHS TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College Hospital NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- King's College London
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04282330
- Sponsor's protocol ID
- CEST in Stroke v4 (03.05.18)
- Status last verified
- Apr 2022
- First submitted
- 10 Feb 2020
- Last updated
- 5 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimising 3D pH-Weighted CEST MRI in Acute Ischaemic Stroke (CEST in Stroke)
- ClinicalTrials.gov ID
- NCT04282330
- Acronym / sponsor ID
- CEST in Stroke v4 (03.05.18)
- Conditions
- Stroke, Acute
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- King's College Hospital NHS TrustUniversity, hospital or other
- Collaborators
- King's College London
- Study start
- 13 Jun 2018 (actual)
- Primary completion
- 30 Apr 2023 (estimated)
- Study completion
- 30 Apr 2023 (estimated)
- First posted
- 24 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CEST imaging performed | Other | Diagnostic Test: 3D CEST imagingCEST 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)). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Clinical diagnosis of acute anterior circulation ischaemic stroke
- Within 24 hours of symptom onset as defined by time since last known well
- Measurable neurological deficit (i.e. impairment of one or more of the following: language, motor function, cognition, gaze, vision, neglect)
- National Institutes of Health Stroke Scale (NIHSS) score of >= 10
- >= 18 years old
Key exclusion criteria (8 listed)
- Any contraindication to MRI (e.g. cardiac pacemaker)
- Clinical diagnosis of posterior circulation ischaemic stroke
- NIHSS <10
- Evidence of intracranial haemorrhage or significant non-stroke intracranial pathology (including CNS [central nervous system] neoplasm) on CT
- Seizure at onset of symptoms unless CT identifies positive evidence of significant brain ischaemia (e.g. arterial occlusion, early ischaemic change)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3D CEST imagingChemical Exchange Saturation Transfer (CEST) is an emerging MRI technique that can acquire multiple endogenous contrasts to probe cerebral metabolism. | Diagnostic test | CEST imaging performed |
Primary outcome
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
Time frame: Within 24 hours of ictus
Percentage of patients where acquisition of a comprehensive raw CEST dataset can be performed over the human brain
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
Time frame: Within 24 hours of ictus
Percentage of patients with quantitative maps of different CEST contrasts produced including APT, NOE, and pH-weighted
Technical feasibility of 3D CEST imaging in acute stroke: Signal-to-noise ratio on the CEST contrasts determined: with and without motion
Time frame: Within 24 hours of ictus
Signal-to-noise ratio on the CEST contrasts determined: with and without motion
3 secondary outcomes
Clinical feasibility: 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
Time frame: Within 24 hours of ictus
Dice score of abnormality seen on CEST contrast & routine stroke sequences
Time frame: Within 24 hours of ictus
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2022.
- Individual participant dataSharing planned: No
Related trials for Stroke, Acute
Recruiting
Connectomic Alterations Following Acute Ischemic Stroke in the MCA Territory
Ischemic Stroke
RecruitingObservational study
Clevidipine for the Antihypertensive Treatment of Acute Intracerebral Hemorrhage
Intracerebral Hemorrhage, Stroke
Active, not recruitingPhase 4
A Study Testing How Well the Drug Extract of Ginkgo Biloba Leaves Tablets Works for People With Memory or Thinking Problems After a Stroke When Added to Standard Treatment
Ischemic Stroke Hospitalized, Impairment, Cognitive
Not yet recruitingPhase 4
Anti-inflammatory and Anti-thrombotic Therapy With colcHicine and Low Dose Rivaroxaban for Major Adverse Cardiovascular Events Reduction in Ischemic Stroke
Ischemic Stroke
Not yet recruitingPhase 3
INTRA-ARTERIAL MeVO TREATMENT (IMP-ACT) Within the ACT-GLOBAL Adaptive Platform Trial-NCT06352632
Stroke, Acute Ischemic, Medium Vessel Occlusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D CEST imaging in people with Stroke, Acute, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Within 24 hours of ictus). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2022.