Establishing a New Ultrasound Technique to Improve Assessment of Chronic Kidney Disease.
NCT ID: NCT06159439
Last Updated: 2023-12-06
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
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NOT_YET_RECRUITING
NA
10 participants
INTERVENTIONAL
2024-01-02
2025-02-02
Brief Summary
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Kidney blood flow can be reliably measured using a specialised type of MRI scan, but this is expensive and difficult to do in people who are unwell. Contrast-enhanced ultrasound (CEUS) is a new technique, which uses a contrast containing microbubbles to measure blood flow. The benefits of this method are that it is relatively inexpensive, the contrast agents are not kidney-damaging and it can be done at the bedside.
We want to compare contrast enhanced ultrasound against the current best-measure of kidney blood flow, to see if it is giving accurate information about kidney blood flow. We will do this by doing both MRI and contrast enhanced ultrasound scans in people with chronic kidney disease and comparing the results.
Detailed Description
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The current non-invasive gold standard technique for renal perfusion measurement is arterial-spin labelling magnetic resonance imaging (ASL-MRI), which has been validated against other measures of perfusion, including contrast agent-based methods. However, MRI has limitations including high cost, and logistical barriers. Therefore, validation of a bed-side measurement tool for renal perfusion would be of significant clinical importance.
This proposal aims to validate CEUS renal cortical perfusion measurement by comparison with quantifiable ASL-MRI parameters of renal microvascular perfusion in individuals with CKD.
TRIAL REGIMEN
All interventions outlined below are for the purposes of research, not usual care.
Study day:
All participants will attend fasted for preceding 2 hours. Demographic details and medical history will be recorded. The patient's concomitant medications which form part of their usual care will be recorded. These will not be adjusted.
Results of blood and urine tests that are collected as part of clinical care will be recorded.
Participants will undergo two scanning sessions, the first using renal MRI at the Sir Peter Mansfield Imaging Centre (SPMIC) to provide a quantitative measure of renal perfusion, and the second to provide the comparator measure of renal perfusion using CEUS performed at Royal Derby Hospital.
Outcomes:
MRI derived perfusion variables: peak time, and peak signal intensity (SI) will be obtained from time intensity curves.
Mean flow velocity (cm/s), cross-sectional area of the lumen (mm2), and hence bulk renal blood flow (ml/s)
CEUS derived perfusion parameters: acoustic index (AU); mean transit time (seconds); perfusion index, which is the ratio of AI to mTT; and wash-in rate (seconds)
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Participants with CKD having MRI and CEUS
10 participants with CKD will have an MRI scan and a contrast enhanced ultrasound scan. The two scans will be done within 7 days of each other.
Contrast enhanced ultrasound scan
Contrast enhanced ultrasound using Sonovue microbubble contrast
MRI scan
Arterial-spin labelling magnetic resonance imaging
Interventions
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Contrast enhanced ultrasound scan
Contrast enhanced ultrasound using Sonovue microbubble contrast
MRI scan
Arterial-spin labelling magnetic resonance imaging
Eligibility Criteria
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Inclusion Criteria
* Ability to give informed consent
Exclusion Criteria
* Solid organ transplant
* Pregnant women
* Known allergy to Sonovue
* Contraindications to MRI
18 Years
ALL
No
Sponsors
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University of Nottingham
OTHER
Responsible Party
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Principal Investigators
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Nick Selby
Role: PRINCIPAL_INVESTIGATOR
University of Nottingham
Central Contacts
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Other Identifiers
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23018
Identifier Type: -
Identifier Source: org_study_id