New Quantitive MRI Parameters in Assessing Kidneys of Autosomal Dominant Polycystic Kidney Disease

Pilot and Feasibility Study: Evaluation of New Quantitative Magnetic Resonance Imaging Parameters in Assessing the Kidneys of Autosomal Dominant Polycystic Kidney Disease

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02250287

Acronym

MRI Pilot

Enrollment

Registered

2014-09-26

Start date

2014-12-31

Completion date

2016-03-31

Last updated

2016-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autosomal Dominant Polycystic Kidney Disease, Kidney Disease

Keywords

autosomal dominant polycystic kidney disease, magnetic resonance imaging parameters, magnetic resonance elastography, apparent diffusion coefficient, blood oxygen level determinations, diffusion weighted imaging

Brief summary

The purpose of this study is to establish normal Magnetic Resonance quantitative values (tissues stiffness, Apparent Diffusion Coefficient values and Blood Oxygen Level Determination values for both renal cortex and medullary tissues and total renal blood flow) for young Autosomal Dominant Polycystic Kidney Disease patients with normal renal function, and normal young adult controls without Autosomal Dominant Polycystic Kidney Disease and normal renal function. Hypothesis: Newer Magnetic Resonance quantitative imaging parameters (tissue stiffness, Apparent Diffusion Coefficient, Blood Oxygen Level Determination levels, Magnetization Transfer and renal blood flow) will have different values in young adult ADPKD patients as compared to normal volunteers.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 30 Years

Healthy volunteers

Yes

Inclusion criteria

ADPKD participants * Male and female subjects between 18-30 years of age * Diagnosis of ADPKD * Glomerular Filtration Rate (GFR) of \> or = to 60 mL/min (Chronic Kidney Disease-Epidemiology Collaboration equation) * Ability to provide written, informed consent

Exclusion criteria

for ADPKD participants * Clinically significant concomitant systemic disease * Subjects with Diabetes Mellitus * Urinary protein excretion * Abnormal urinalysis suggestive of concomitant glomerular disease * Subjects having contraindications to, or interference with MRI assessments * Subjects with supine blood pressure higher than 140/90 mm Hg or taking blood pressure medications Inclusion criteria for Normal Volunteers * Male and female subjects between 18-30 years of age * Glomerular Filtration Rate (GFR) of \> or = to 60 mL/min (Chronic Kidney Disease-Epidemiology Collaboration equation) * Ability to provide written, informed consent

Design outcomes

Primary

Measure	Time frame	Description
Evaluate renal tissue stiffness	baseline	The renal parenchymal tissue stiffness is measured in kilopascals with magnetic resonance elastography sequence.
Magnetization transfer ratio	baseline	The magnetization transfer ratio of renal tissue is measured with magnetization transfer sequence and expressed as a ratio.
Diffusion	baseline	Diffusion is quantified as apparent diffusion coefficient (x10-3/mm2) in renal tissue is measured with intravoxel incoherent motion imaging (IVIM) sequence and diffusion tensor imaging (DTI).
Perfusion quantified as blood flow in mL/s.	baseline	Perfusion in the renal tissue is measured with arterial spin labeling sequence and phase contrast magnetic resonance angiography.

Countries

United States

Outcome results