Multiparametric MRINCT06884410
Reproducibility of Multiparametric Renal Magnetic Resonance Imaging on 1.5T MRI Scanners
A study testing MRI in people with Multiparametric MRI, run by Mario Negri Institute for Pharmacological Research at 4 sites in 4 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiparametric MRI
- What is being tested?
- MRI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 4 sitesin 4 countries
- Study dates
- 12 Apr 2025to Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
4 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 4 countries
Denmark1 site, 1 recruiting
- Not yet recruiting
Aarhus University Hospital
Aarhus, 8200
Niels H Buus, M.D., +4530313404, nhb@biomed.au.dk
Niels H Buus, M.D.
Germany1 site, 1 recruiting
- Not yet recruiting
University Medical Center Mannheim, Medical Faculty Mannheim, Heidelberg University
Mannheim, 68197
Dominik Nörenberg, MHBA, +4906213832067, Dominik.Noerenberg@medma.uni-heidelberg.de
Dominik Nörenberg, MHBA
Italy1 site, 1 recruiting
- Recruiting
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, BO, 40138
Matteo Renzulli, M.D., +390512141228, matteo.renzulli@aosp.bo.it
Matteo Renzulli, M.D.
Spain1 site, 1 recruiting
- Not yet recruiting
Clínica Universidad de Navarra
Pamplona, Navarre, 31008
Nuria G Fernandez, M.D., +34948255400, nrgarcia@unav.es
Nuria G Fernandez, M.D.
About this study
Official title: Reproducibility of Multiparametric Renal Magnetic Resonance Imaging on 1.5T MRI Scanners (RESPECT_1.5T Sub-study)
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.
Read the 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.
- Conditions
- Multiparametric MRI
- Being tested
- MRI
- Keywords
- multiparametric MRI, standardization, reproducibility, kidney, MRI scanners
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDevice
Multiparametric renal MRI on 1.5T scanners
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | Experimental | Healthy volunteers selected from 4 different centers. Each center will recruit 6 males and 6 females each. Receives: Device: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volumes
Total kidney, cortical and medullary volumes (in mL)
Measured: At day 0 and from 7 to 14 days after
Oxygenation
Renal tissue oxygenation obtained by measuring the R2* relaxation rate (in 1/ms)
Measured: At day 0 and from 7 to 14 days after
Diffusion coefficient
Apparent diffusion coefficient (in cm2/s)
Measured: At day 0 and from 7 to 14 days after
Tissue perfusion
Renal tissue perfusion (in mL/100mL/min)
Measured: At day 0 and from 7 to 14 days after
Blood flow
Renal blood flow (in mL/min)
Measured: At day 0 and from 7 to 14 days after
Relaxation times
T1 and T2 relaxation times (in ms)
Measured: At day 0 and from 7 to 14 days after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2025
- Study start12 Apr 2025
- Primary completionApr 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Multiparametric MRIStudies of the same condition, open and under way.
- More trials run by Mario Negri Institute for Pharmacological ResearchThe 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
- 48 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giuseppe Remuzzi, M.D., Principal investigator, Istituto Di Ricerche Farmacologiche Mario Negri
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06884410
- Sponsor's protocol ID
- RESPECT_1.5T
- Status last verified
- Aug 2025
- First submitted
- 13 Mar 2025
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26796439Levey 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.
PubMed 19414839Selby 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.
PubMed 30137584Caroli 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.
PubMed 30137582Xie 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.
PubMed 27630064Grenier 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.
PubMed 27067530
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reproducibility of Multiparametric Renal Magnetic Resonance Imaging on 1.5T MRI Scanners (RESPECT_1.5T Sub-study)
- ClinicalTrials.gov ID
- NCT06884410
- Acronym / sponsor ID
- RESPECT_1.5T
- Conditions
- Multiparametric MRI
- Keywords
- multiparametric MRI, standardization, reproducibility, kidney, MRI scanners
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Mario Negri Institute for Pharmacological ResearchUniversity, hospital or other
- Study start
- 12 Apr 2025 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 19 Mar 2025 (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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | Experimental | Device: MRIHealthy volunteers selected from 4 different centers. Each center will recruit 6 males and 6 females each. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| MRIMultiparametric renal MRI on 1.5T scanners | Device | Healthy volunteers |
Primary outcome
Volumes
Time frame: At day 0 and from 7 to 14 days after
Total kidney, cortical and medullary volumes (in mL)
Oxygenation
Time frame: At day 0 and from 7 to 14 days after
Renal tissue oxygenation obtained by measuring the R2* relaxation rate (in 1/ms)
Diffusion coefficient
Time frame: At day 0 and from 7 to 14 days after
Apparent diffusion coefficient (in cm2/s)
Tissue perfusion
Time frame: At day 0 and from 7 to 14 days after
Renal tissue perfusion (in mL/100mL/min)
Blood flow
Time frame: At day 0 and from 7 to 14 days after
Renal blood flow (in mL/min)
Relaxation times
Time frame: At day 0 and from 7 to 14 days after
T1 and T2 relaxation times (in ms)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2025.
- Background: PubMed 26796439McAlinden 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.
- Background: PubMed 19414839Levey 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.
- Background: PubMed 30137584Selby 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.
- Background: PubMed 30137582Caroli 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.
- Background: PubMed 27630064Xie 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.
- Background: PubMed 27067530Grenier 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.
- 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.
Giuseppe Remuzzi, M.D. principal investigator
Istituto Di Ricerche Farmacologiche Mario Negri
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI in people with Multiparametric MRI, run by Mario Negri Institute for Pharmacological Research at 4 sites in 4 countries.
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 5 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 2 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Denmark, Germany, Italy, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matias Trillini, M.D. (+390354535411, matias.trillini@marionegri.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Volumes (time frame: At day 0 and from 7 to 14 days after). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06884410, which also lists 6 linked publications.
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 2 Sep 2025.