Clinical trial NCT02250287: New Quantitive MRI Parameters in Assessing Kidneys of Autosomal Dominant Polycystic Kidney Disease
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 type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2014-09-26
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Evaluate renal tissue stiffness
timeFrame: baseline
measure: Magnetization transfer ratio
timeFrame: baseline
measure: Diffusion
timeFrame: baseline
measure: Perfusion quantified as blood flow in mL/s.
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Sudhakar Venkatesh, MD
role: PRINCIPAL_INVESTIGATOR
References: