Reproducibility of multiparametric kidney MRI on 1.5T scanners

Reproducibility of Multiparametric Renal Magnetic Resonance Imaging on 1.5T MRI Scanners (RESPECT_1.5T Sub-study)

This project will test how consistently multiparametric kidney MRI measurements can be obtained on common 1.5T MRI scanners in healthy adults aged 18–70.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 48 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Mario Negri Institute for Pharmacological Research (other)
• Locations: 4 sites (Aarhus and 3 other locations)
• Trial ID: NCT06884410 on ClinicalTrials.gov

What this trial studies

This multicenter prospective study enrolls healthy volunteers to measure how reproducible multiparametric renal MRI metrics are when acquired on 1.5T scanners using standardized acquisition and processing protocols. Participants will undergo repeated MRI scans at participating sites to quantify within- and between-scanner variability and to compare reproducibility across sex and age groups. A subgroup of participants already enrolled in the RESPECT trial will permit direct comparison of reproducibility between 1.5T and 3T field strengths. The study aims to inform harmonized protocols and normative benchmarks to support wider clinical use of renal MRI.

Who should consider this trial

Good fit: Ideal candidates are healthy men and women aged 18–70 with normal blood pressure, normal kidney function (eGFR ≥60 mL/min/1.73 m2), negative urine tests for blood/protein, no ongoing medical therapy, and no MRI contraindications.

Not a fit: People with chronic kidney disease, active medical treatments (e.g., for diabetes or dyslipidemia), past or current cancer, pregnancy, or MRI-incompatible implants will not qualify and are unlikely to receive direct clinical benefit from this imaging reproducibility study.

Why it matters

Potential benefit: If successful, this work could enable reliable kidney MRI measures on widely available 1.5T scanners, helping earlier detection and more consistent monitoring of kidney disease in more clinical centers.

How similar studies have performed: Previous multicenter work—most notably the RESPECT trial—has shown repeatability of multiparametric renal MRI at 3T, but reproducibility on commonly used 1.5T scanners has been less well studied.

Eligibility criteria

Inclusion Criteria:

* Provision of written informed consent prior to any study specific procedures
* Male and female subjects aged \[18-70\] years
* Office SBP values \< 140 mmHg and DBP values ≤ 90 mmHg, under no antihypertensive therapy
* Normal renal function defined as: estimated glomerular filtration rate \[eGFR\] ≥ 60mL/min/1.73m2 (using CKD-EPI Creatinine Equation)
* Negative result upon urine testing for haematuria or proteinuria.

Exclusion Criteria:

* Previous enrollment in the present substudy
* Contraindications to MRI including caustrophobia, pregnancy, cardiac pacemakers or other MRI-incompatible prostheses
* Ongoing therapy (e.g. for diabetes, dyslipidemia, or any acute disease)
* Past or current oncological pathology

Where this trial is running

Aarhus and 3 other locations

• Aarhus University Hospital — Aarhus, Denmark (NOT_YET_RECRUITING)
• University Medical Center Mannheim, Medical Faculty Mannheim, Heidelberg University — Mannheim, Germany (NOT_YET_RECRUITING)
• IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna, BO, Italy (RECRUITING)
• Clínica Universidad de Navarra — Pamplona, Navarre, Spain (NOT_YET_RECRUITING)

Study contacts

• Principal investigator: Giuseppe Remuzzi, M.D. — Istituto Di Ricerche Farmacologiche Mario Negri
• Study coordinator: Matias Trillini, M.D.

Conditions: Multiparametric MRI, multiparametric MRI, standardization, reproducibility, kidney, MRI scanners