Establishing a New Ultrasound Technique to Improve Assessment of Chronic Kidney Disease.

NCT06159439 | Unknown

• 1 other identifier: 23018
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief 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). 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.

Conditions

Chronic Kidney Diseases

Keywords

imaging; perfusion; contrast enhanced ultrasound

Outcome Measures

Primary Outcomes (1)

• 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.

  MRI scan and contrast enhanced ultrasound scan to be performed within 7 days of each other.

Secondary Outcomes (3)

• Repeatability of the CEUS measurements

  1 scan

• Correlation between global perfusion from PC-MRI corrected flow measures and CEUS

  MRI scan and CEUS done within 7 days of each other

• Correlation between kinetic time-intensity parameters of CEUS and time-resolved MRA

  MRI scan and CEUS done within 7 days of each other

Study Arms (1)

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.

Diagnostic Test: Contrast enhanced ultrasound scan; Diagnostic Test: MRI scan

Interventions

Contrast enhanced ultrasound scan DIAGNOSTIC_TEST

Contrast enhanced ultrasound using Sonovue microbubble contrast

Participants with CKD having MRI and CEUS

MRI scan DIAGNOSTIC_TEST

Arterial-spin labelling magnetic resonance imaging

Participants with CKD having MRI and CEUS

Eligibility Criteria

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

You may qualify if:

• CKD 3b or CKD4
• Ability to give informed consent

You may not qualify if:

• Autosomal dominant polycystic kidney disease
• Solid organ transplant
• Pregnant women
• Known allergy to Sonovue
• Contraindications to MRI

Sponsors & Collaborators

• University of Nottingham: lead

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Nick Selby

  University of Nottingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kerry Horne, BMBCh

CONTACT

07469037422; kerry.horne@nottingham.ac.uk

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: November 28, 2023
• First Posted: December 6, 2023
• Study Start: January 2, 2024
• Primary Completion: February 2, 2025
• Study Completion: February 2, 2025
• Last Updated: December 6, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share