Optimising 3D pH-Weighted CEST MRI in Acute Ischaemic Stroke (CEST in Stroke)

NCT04282330 | Unknown

• 1 other identifier: CEST in Stroke v4 (03.05.18)
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Stroke, Acute

Outcome Measures

Primary Outcomes (3)

• 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

  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

  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

  Within 24 hours of ictus

Secondary Outcomes (3)

• Clinical feasibility: Number of patients recruited per month (determined at completion of study)

  Within 24 hours of ictus

• Clinical feasibility: Patients tolerating full scan protocol per month

  Within 24 hours of ictus

• Dice score of abnormality seen on CEST contrast & routine stroke sequences

  Within 24 hours of ictus

Study Arms (1)

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)).

Diagnostic Test: 3D CEST imaging

Interventions

3D CEST imaging DIAGNOSTIC_TEST

Chemical Exchange Saturation Transfer (CEST) is an emerging MRI technique that can acquire multiple endogenous contrasts to probe cerebral metabolism.

CEST imaging performed

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• King's College Hospital NHS Trust: lead
• King's College London: collaborator

Study Sites (1)

King's College Hospital

London, SE5 9RS, United Kingdom

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2020
• First Posted: February 24, 2020
• Study Start: June 13, 2018
• Primary Completion: April 30, 2023
• Study Completion: April 30, 2023
• Last Updated: April 5, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)