Clinical trial NCT06884410: Reproducibility of Multiparametric Renal Magnetic Resonance Imaging on 1.5T MRI Scanners
Official title: Reproducibility of Multiparametric Renal Magnetic Resonance Imaging on 1.5T MRI Scanners (RESPECT_1.5T Sub-study)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Multiparametric MRI
Keywords: multiparametric MRI
standardization
reproducibility
kidney
MRI scanners
Lead sponsor: Mario Negri Institute for Pharmacological Research
Sponsor class: OTHER
First posted: 2025-03-19
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Detailed description: Over the past decade, renal Magnetic Resonance Imaging (MRI) has emerged as a promising non-invasive technique for improved understanding and characterisation of renal pathophysiology.

Despite renal MRI potential to address several key clinical questions, current methodological differences across studies hinder reliable comparisons of the results, which can only be regarded as preliminary. Widely accepted normative values of renal MRI measures to establish benchmarks for early diagnosis, prognosis or treatment planning are not available. Standardization of acquisition and processing protocols across centres is therefore needed, and this is a necessary preliminary step towards multiparametric renal MRI wider use in clinical research and ultimate adoption in clinical practice.

The ongoing "Exploratory multicentre clinical study to assess repeatability, reproducibility, acceptability and clinical validity of multiparametric renal Magnetic Resonance Imaging (RESPECT Trial, NCT05229263)" trial will provide relevant information on repeatability and reproducibility of MRI measures obtained from multiparametric MRI scans acquired on 3T scanners, that represent the state-of-the-art for clinical research. However, 3T MRI scanners are not available in most clinical centres, where instead lower-field (1.5T) MRI scanners are much more common. Investigating reproducibility of renal MRI measures on 1.5T scanners and assessing possible differences in reproducibility across magnetic field strength would be needed towards translation of the results of the RESPECT clinical study to clinics.

The possible advantages that can derive from participating in the present research are essentially linked to the possibility to specifically assess the renal function with multiparametric MRI, that is not part of the routine clinical practice. More generally, in the long term, it will be possible for CKD patients to benefit from the results of this study that is aimed at demonstrating the reproducibility and the clinical validity of multiparametric MRI.

Participation in the study will not entail any additional risk to subjects' health. All clinical MRI safety procedures will be strictly followed. Indeed, multiparametric MRI acquisitions required by this research will be performed without the administration of contrast media and do not present risks in either short or long term.

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

Primary outcomes:
measure: Volumes
timeFrame: At day 0 and from 7 to 14 days after
measure: Oxygenation
timeFrame: At day 0 and from 7 to 14 days after
measure: Diffusion coefficient
timeFrame: At day 0 and from 7 to 14 days after
measure: Tissue perfusion
timeFrame: At day 0 and from 7 to 14 days after
measure: Blood flow
timeFrame: At day 0 and from 7 to 14 days after
measure: Relaxation times
timeFrame: At day 0 and from 7 to 14 days after
Secondary outcomes:
Other outcomes:
Locations:
city: Århus
country: Denmark
facility: Aarhus University Hospital
city: Mannheim
country: Germany
facility: University Medical Center Mannheim, Medical Faculty Mannheim, Heidelberg University
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna
state: BO
city: Pamplona
country: Spain
facility: Clínica Universidad de Navarra
state: Navarra
Study officials:
affiliation: Istituto Di Ricerche Farmacologiche Mario Negri
name: Giuseppe Remuzzi, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.