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

Kidney Disease Clinical Trial

— MRI Pilot  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02250287
• Other study ID #: 14-000866
• Status: Completed
• Phase: N/A
• First received: September 18, 2014
• Last updated: June 16, 2016
• Start date: December 2014
• Est. completion date: March 2016

Study information

• Verified date: May 2016
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 30 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Autosomal Dominant Polycystic Kidney Disease
• Kidney Disease
• Kidney Diseases
• Polycystic Kidney Diseases
• Polycystic Kidney, Autosomal Dominant

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate renal tissue stiffness	The renal parenchymal tissue stiffness is measured in kilopascals with magnetic resonance elastography sequence.	baseline	No
Primary	Magnetization transfer ratio	The magnetization transfer ratio of renal tissue is measured with magnetization transfer sequence and expressed as a ratio.	baseline	No
Primary	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	No
Primary	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	No