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

Sponsor

Mayo Clinic (Other)

Overall Status

Completed

CT.gov ID

NCT02250287

Collaborator

(none)

Enrollment

Location

Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Autosomal Dominant Polycystic Kidney Disease Kidney Disease

Study Design

Study Type:

Observational

Actual Enrollment :

20 participants

Observational Model:

Case-Control

Time Perspective:

Retrospective

Official Title:

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

Study Start Date :

Dec 1, 2014

Actual Primary Completion Date :

Mar 1, 2016

Actual Study Completion Date :

Mar 1, 2016

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 30 Years

Sexes Eligible for Study:

All

Accepts 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

Exclusion criteria for Normal Volunteers

Previous personal or family history of kidney disease
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