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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorMario Negri Institute for Pharmacological Research

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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)

Disqualifiers

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 design

Design model

Single group

Treatments tested in this trial

  • MRI

    Device

    Multiparametric renal MRI on 1.5T scanners

Treatment groups

48 Participants
are divided into 1 treatment group
Group A: Healthy volunteersExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Volumes

Total kidney, cortical and medullary volumes (in mL)

Time frame
At day 0 and from 7 to 14 days after
2

Oxygenation

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

Time frame
At day 0 and from 7 to 14 days after
3

Diffusion coefficient

Apparent diffusion coefficient (in cm2/s)

Time frame
At day 0 and from 7 to 14 days after
4

Tissue perfusion

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

Time frame
At day 0 and from 7 to 14 days after

Secondary outcomes

Other outcomes

Sponsors and contacts

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