Chronic Kidney DiseasesNCT06159439
Establishing a New Ultrasound Technique to Improve Assessment of Chronic Kidney Disease.
A study testing Contrast enhanced ultrasound scan and MRI scan in people with Chronic Kidney Diseases, run by University of Nottingham.
Trial summary
Blood flow to the kidneys is important in the development of kidney diseases. Currently we do not have ways of measuring and monitoring kidney blood flow for patients in real-time. This is a major barrier to investigation and management of acute kidney injury (AKI) and chronic kidney disease (CKD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Diseases
- What is being tested?
- Contrast enhanced ultrasound scan and MRI scan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 2 Jan 2024to 2 Feb 2025
- 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
- CKD 3b or CKD4
- Ability to give informed consent
Who cannot join
- Autosomal dominant polycystic kidney disease
- Solid organ transplant
- Pregnant women
- Known allergy to Sonovue
- Contraindications to MRI
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Validation of Contrast Enhanced Ultrasound (CEUS) for the Assessment of Renal Perfusion Using Renal Magnetic Resonance Imaging (MRI) in Chronic Kidney Disease (CKD
Blood flow to the kidneys is important in the development of kidney diseases. Currently we do not have ways of measuring and monitoring kidney blood flow for patients in real-time. This is a major barrier to investigation and management of acute kidney injury (AKI) and chronic kidney disease (CKD).
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.
Read the detailed description
Renal perfusion, the delivery of oxygenated blood to kidney tissues, is relevant to a number of acute and chronic kidney diseases. Despite this, we do not have methods in current clinical practice to measure renal perfusion and monitor the response to supportive treatments in real time. This is a major barrier to investigation and management of acute kidney injury (AKI) and chronic kidney disease (CKD).
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
- Chronic Kidney Diseases
- Being tested
- Contrast enhanced ultrasound scan, MRI scan
- Keywords
- imaging, perfusion, contrast enhanced ultrasound
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contrast enhanced ultrasound scanDiagnostic test
Contrast enhanced ultrasound using Sonovue microbubble contrast
MRI scanDiagnostic test
Arterial-spin labelling magnetic resonance imaging
| Study group | Role | What they receive |
|---|---|---|
| Participants with CKD having MRI and CEUS | Experimental | 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. Receives: Diagnostic Test: Contrast enhanced ultrasound scan; Diagnostic Test: MRI scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between ASL-MRI measures of cortical perfusion (ml/ 100g/min) and CEUS measures of renal microvascular blood flow.
The primary outcome will be the correlation between ASL-MRI measures of cortical perfusion (ml/ 100g/min) and CEUS measures of renal microvascular blood flow. As CEUS and ASL-MRI generate different units of measurement, correlations (rather than Bland-Altman analyses) will be used. We will define an ideal result as correlation coefficient r≥0.65, and adequate correlation coefficient r≥0.4.
Measured: MRI scan and contrast enhanced ultrasound scan to be performed within 7 days of each other.
Secondary outcomes (3)
Repeatability of the CEUS measurements
Repeatability of markers of perfusion between 5 flash-reperfusion sequences taken during 1 scan session
Measured: 1 scan
Correlation between global perfusion from PC-MRI corrected flow measures and CEUS
As CEUS and ASL-MRI generate different units of measurement, correlations (rather than Bland-Altman analyses) will be used. We will define an ideal result as correlation coefficient r≥0.65, and adequate correlation coefficient r≥0.4.
Measured: MRI scan and CEUS done within 7 days of each other
Correlation between kinetic time-intensity parameters of CEUS and time-resolved MRA
As CEUS and ASL-MRI generate different units of measurement, correlations (rather than Bland-Altman analyses) will be used. We will define an ideal result as correlation coefficient r≥0.65, and adequate correlation coefficient r≥0.4.
Measured: MRI scan and CEUS done within 7 days of each other
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2023
- Study start2 Jan 2024 (estimated)
- Primary completion2 Feb 2025 (estimated)
- Study completion2 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe 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
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nick Selby, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06159439
- Sponsor's protocol ID
- 23018
- Status last verified
- Nov 2023
- First submitted
- 28 Nov 2023
- Last updated
- 6 Dec 2023
- 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 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Contrast Enhanced Ultrasound (CEUS) for the Assessment of Renal Perfusion Using Renal Magnetic Resonance Imaging (MRI) in Chronic Kidney Disease (CKD
- ClinicalTrials.gov ID
- NCT06159439
- Acronym / sponsor ID
- 23018
- Conditions
- Chronic Kidney Diseases
- Keywords
- imaging, perfusion, contrast enhanced ultrasound
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- 2 Jan 2024 (estimated)
- Primary completion
- 2 Feb 2025 (estimated)
- Study completion
- 2 Feb 2025 (estimated)
- First posted
- 6 Dec 2023 (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.
Blood flow to the kidneys is important in the development of kidney diseases. Currently we do not have ways of measuring and monitoring kidney blood flow for patients in real-time. This is a major barrier to investigation and management of acute kidney injury (AKI) and chronic kidney disease (CKD).
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
Renal perfusion, the delivery of oxygenated blood to kidney tissues, is relevant to a number of acute and chronic kidney diseases. Despite this, we do not have methods in current clinical practice to measure renal perfusion and monitor the response to supportive treatments in real time. This is a major barrier to investigation and management of acute kidney injury (AKI) and chronic kidney disease (CKD).
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)
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with CKD having MRI and CEUS | Experimental | Diagnostic Test: Contrast enhanced ultrasound scan, Diagnostic Test: MRI scan10 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- CKD 3b or CKD4
- Ability to give informed consent
Key exclusion criteria (5 listed)
- Autosomal dominant polycystic kidney disease
- Solid organ transplant
- Pregnant women
- Known allergy to Sonovue
- Contraindications to MRI
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 |
|---|---|---|
| Contrast enhanced ultrasound scanContrast enhanced ultrasound using Sonovue microbubble contrast | Diagnostic test | Participants with CKD having MRI and CEUS |
| MRI scanArterial-spin labelling magnetic resonance imaging | Diagnostic test | Participants with CKD having MRI and CEUS |
Primary outcome
Correlation between ASL-MRI measures of cortical perfusion (ml/ 100g/min) and CEUS measures of renal microvascular blood flow.
Time frame: MRI scan and contrast enhanced ultrasound scan to be performed within 7 days of each other.
The primary outcome will be the correlation between ASL-MRI measures of cortical perfusion (ml/ 100g/min) and CEUS measures of renal microvascular blood flow. As CEUS and ASL-MRI generate different units of measurement, correlations (rather than Bland-Altman analyses) will be used. We will define an ideal result as correlation coefficient r≥0.65, and adequate correlation coefficient r≥0.4.
3 secondary outcomes
Repeatability of the CEUS measurements
Time frame: 1 scan
Correlation between global perfusion from PC-MRI corrected flow measures and CEUS
Time frame: MRI scan and CEUS done within 7 days of each other
Correlation between kinetic time-intensity parameters of CEUS and time-resolved MRA
Time frame: MRI scan and CEUS done within 7 days of each other
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2023.
- Individual participant dataSharing planned: No
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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.
Nick Selby principal investigator
University of Nottingham
Questions about this trial
What is this clinical trial studying?
A study testing Contrast enhanced ultrasound scan and MRI scan in people with Chronic Kidney Diseases, run by University of Nottingham.
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 2 inclusion and 5 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 6 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Kerry Horne, BMBCh (07469037422, kerry.horne@nottingham.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between ASL-MRI measures of cortical perfusion (ml/ 100g/min) and CEUS measures of renal microvascular blood flow. (time frame: MRI scan and contrast enhanced ultrasound scan to be performed within 7 days of each other.). 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 6 Dec 2023.