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Clinical Trials in Italy / NCT06884410
Recruiting Not applicable

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

NCT06884410 · tracked via the Priya Life Science Italy tracker
Sponsor
Mario Negri Institute for Pharmacological Research
Phase
Not applicable
Started
2025-04-12
Last updated
2025-09-02

Condition(s) studied

Multiparametric MRI

Investigational drug(s) / intervention(s)

MRI

MRI: Multiparametric renal MRI on 1.5T scanners

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
Accepted
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 outcome measure(s)

  • Volumes — At day 0 and from 7 to 14 days after
    Total kidney, cortical and medullary volumes (in mL)
  • Oxygenation — 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 — At day 0 and from 7 to 14 days after
    Apparent diffusion coefficient (in cm2/s)
  • Tissue perfusion — At day 0 and from 7 to 14 days after
    Renal tissue perfusion (in mL/100mL/min)
  • Blood flow — At day 0 and from 7 to 14 days after
    Renal blood flow (in mL/min)
  • Relaxation times — At day 0 and from 7 to 14 days after
    T1 and T2 relaxation times (in ms)

Trial sites (4)

FacilityCityRegionStatus
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 Recruiting
Clínica Universidad de Navarra Pamplona Navarre Not Yet Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06884410 on ClinicalTrials.gov ↗ ← All trials in Italy