Optimising 3D pH-Weighted CEST MRI in Acute Ischaemic Stroke (CEST in Stroke)
NCT ID: NCT04282330
Last Updated: 2022-04-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
28 participants
INTERVENTIONAL
2018-06-13
2023-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Penumbra and Recanalisation Acute Computed Tomography in Ischaemic Stroke Evaluation
NCT02360670
Cerebral Haemodynamics in Stroke Thrombolysis Study (CHIST)
NCT02928926
Emergency Stroke Unit for Acute Cerebrovascular Events ( ESU-ACE-C )
NCT06522269
Predictive Factors Of Acute Ischemic Stroke Outcome in Adult
NCT03700879
Perfusion Imaging Evaluation for Ischemic Stroke on 6-24 Hours Undergoing Endovascular Thrombectomy
NCT03502408
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
CEST imaging performed
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)).
3D CEST imaging
Chemical Exchange Saturation Transfer (CEST) is an emerging MRI technique that can acquire multiple endogenous contrasts to probe cerebral metabolism.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
3D CEST imaging
Chemical Exchange Saturation Transfer (CEST) is an emerging MRI technique that can acquire multiple endogenous contrasts to probe cerebral metabolism.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
King's College London
OTHER
King's College Hospital NHS Trust
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
King's College Hospital
London, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CEST in Stroke v4 (03.05.18)
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.