New Quantitive MRI Parameters in Assessing 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.

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Key information

Conditions

Autosomal Dominant Polycystic Kidney Disease Abnormalities, Multiple Ciliopathies Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genetic Diseases, Inborn Kidney Disease Kidney Diseases Kidney Diseases, Cystic Male Urogenital Diseases Polycystic Kidney Diseases Polycystic Kidney, Autosomal Dominant Urogenital Diseases Urologic Diseases

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Evaluate renal tissue stiffness

Time frame: baseline

The renal parenchymal tissue stiffness is measured in kilopascals with magnetic resonance elastography sequence.
Magnetization transfer ratio

Time frame: baseline

The magnetization transfer ratio of renal tissue is measured with magnetization transfer sequence and expressed as a ratio.
Diffusion

Time frame: 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.

Time frame: baseline

Perfusion in the renal tissue is measured with arterial spin labeling sequence and phase contrast magnetic resonance angiography.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Acronym: MRI Pilot

Important dates

Study start: 2014
Primary completion: 2016
Study completion: 2016
First posted: Sep 26, 2014
Registry last updated: Jun 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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