Reproducibility of Multiparametric Renal Magnetic Resonance Imaging on 1.5T MRI Scanners

NCT06884410 | Recruiting

• 1 other identifier: RESPECT_1.5T
• Study Type: interventional
• Target: 48
• Locations: 4 countries
• Sites: 4

Brief Summary

This is an interventional, multicenter, prospective study involving healthy volunteers, to primarily assess the reproducibility of multiparametric renal MRI on 1.5T scanners. The study is also aimed at assessing possible differences in renal MRI reproducibility on 1.5T MRI scanners by sex and age, and assessing possible differences in renal MRI reproducibility across field strengths (1.5T vs 3T) in the subgroup of subjects enrolled in both RESPECT clinical study and in the current subproject.

Conditions

Multiparametric MRI

Keywords

multiparametric MRI; standardization; reproducibility; kidney; MRI scanners

Outcome Measures

Primary Outcomes (6)

• Volumes

  Total kidney, cortical and medullary volumes (in mL)

  At day 0 and from 7 to 14 days after

• Oxygenation

  Renal tissue oxygenation obtained by measuring the R2\* relaxation rate (in 1/ms)

  At day 0 and from 7 to 14 days after

• Diffusion coefficient

  Apparent diffusion coefficient (in cm2/s)

  At day 0 and from 7 to 14 days after

• Tissue perfusion

  Renal tissue perfusion (in mL/100mL/min)

  At day 0 and from 7 to 14 days after

• Blood flow

  Renal blood flow (in mL/min)

  At day 0 and from 7 to 14 days after

• Relaxation times

  T1 and T2 relaxation times (in ms)

  At day 0 and from 7 to 14 days after

Study Arms (1)

Healthy volunteers

EXPERIMENTAL

Healthy volunteers selected from 4 different centers. Each center will recruit 6 males and 6 females each.

Device: MRI

Interventions

MRI DEVICE

Multiparametric renal MRI on 1.5T scanners

Healthy volunteers

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mario Negri Institute for Pharmacological Research: lead

Study Sites (4)

Aarhus University Hospital

Aarhus, 8200, Denmark

NOT YET RECRUITING

University Medical Center Mannheim, Medical Faculty Mannheim, Heidelberg University

Mannheim, 68197, Germany

NOT YET RECRUITING

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, BO, 40138, Italy

RECRUITING

Clínica Universidad de Navarra

Pamplona, Navarre, 31008, Spain

NOT YET RECRUITING

Related Publications (6)

• McAlinden C, Khadka J, Pesudovs K. Precision (repeatability and reproducibility) studies and sample-size calculation. J Cataract Refract Surg. 2015 Dec;41(12):2598-604. doi: 10.1016/j.jcrs.2015.06.029. No abstract available.

  PMID: 26796439 BACKGROUND

• Levey AS, Stevens LA, Schmid CH, Zhang YL, Castro AF 3rd, Feldman HI, Kusek JW, Eggers P, Van Lente F, Greene T, Coresh J; CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration). A new equation to estimate glomerular filtration rate. Ann Intern Med. 2009 May 5;150(9):604-12. doi: 10.7326/0003-4819-150-9-200905050-00006.

  PMID: 19414839 BACKGROUND

• Selby NM, Blankestijn PJ, Boor P, Combe C, Eckardt KU, Eikefjord E, Garcia-Fernandez N, Golay X, Gordon I, Grenier N, Hockings PD, Jensen JD, Joles JA, Kalra PA, Kramer BK, Mark PB, Mendichovszky IA, Nikolic O, Odudu A, Ong ACM, Ortiz A, Pruijm M, Remuzzi G, Rorvik J, de Seigneux S, Simms RJ, Slatinska J, Summers P, Taal MW, Thoeny HC, Vallee JP, Wolf M, Caroli A, Sourbron S. Magnetic resonance imaging biomarkers for chronic kidney disease: a position paper from the European Cooperation in Science and Technology Action PARENCHIMA. Nephrol Dial Transplant. 2018 Sep 1;33(suppl_2):ii4-ii14. doi: 10.1093/ndt/gfy152.

  PMID: 30137584 BACKGROUND

• Caroli A, Pruijm M, Burnier M, Selby NM. Functional magnetic resonance imaging of the kidneys: where do we stand? The perspective of the European COST Action PARENCHIMA. Nephrol Dial Transplant. 2018 Sep 1;33(suppl_2):ii1-ii3. doi: 10.1093/ndt/gfy181. No abstract available.

  PMID: 30137582 BACKGROUND

• Xie L, Bennett KM, Liu C, Johnson GA, Zhang JL, Lee VS. MRI tools for assessment of microstructure and nephron function of the kidney. Am J Physiol Renal Physiol. 2016 Dec 1;311(6):F1109-F1124. doi: 10.1152/ajprenal.00134.2016. Epub 2016 Sep 14.

  PMID: 27630064 BACKGROUND

• Grenier N, Merville P, Combe C. Radiologic imaging of the renal parenchyma structure and function. Nat Rev Nephrol. 2016 Jun;12(6):348-59. doi: 10.1038/nrneph.2016.44. Epub 2016 Apr 12.

  PMID: 27067530 BACKGROUND

Study Officials

• Giuseppe Remuzzi, M.D.

  Istituto Di Ricerche Farmacologiche Mario Negri

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matias Trillini, M.D.

CONTACT

+390354535411; matias.trillini@marionegri.it

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: March 13, 2025
• First Posted: March 19, 2025
• Study Start: April 12, 2025
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: September 2, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1); IT (1); DE (1); ES (1)