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

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

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.

Study Overview

• Status: Completed
• Conditions: Kidney Disease; Autosomal Dominant Polycystic Kidney Disease

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Ten known ADPKD patients between the ages of 18-30, and 10 normal non-ADPKD volunteers between the ages of 18-30, who are MRI compatible will be studied. Study participants will be selected from a list queried from the Polycystic Kidney Disease database.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate renal tissue stiffness	The renal parenchymal tissue stiffness is measured in kilopascals with magnetic resonance elastography sequence.	baseline
Magnetization transfer ratio	The magnetization transfer ratio of renal tissue is measured with magnetization transfer sequence and expressed as a ratio.	baseline
Diffusion	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).	baseline
Perfusion quantified as blood flow in mL/s.	Perfusion in the renal tissue is measured with arterial spin labeling sequence and phase contrast magnetic resonance angiography.	baseline

Collaborators and Investigators

• Sponsor: Mayo Clinic

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (ACTUAL): March 1, 2016
• Study Completion (ACTUAL): March 1, 2016

Study Registration Dates

• First Submitted: September 18, 2014
• First Submitted That Met QC Criteria: September 24, 2014
• First Posted (ESTIMATE): September 26, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): June 17, 2016
• Last Update Submitted That Met QC Criteria: June 16, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: autosomal dominant polycystic kidney disease; apparent diffusion coefficient; diffusion weighted imaging; magnetic resonance elastography; magnetic resonance imaging parameters; blood oxygen level determinations
• Additional Relevant MeSH Terms: Urologic Diseases; Congenital Abnormalities; Genetic Diseases, Inborn; Joint Diseases; Musculoskeletal Diseases; Muscular Diseases; Musculoskeletal Abnormalities; Abnormalities, Multiple; Kidney Diseases, Cystic; Ciliopathies; Kidney Diseases; Polycystic Kidney Diseases; Polycystic Kidney, Autosomal Dominant; Arthrogryposis
• Other Study ID Numbers: 14-000866