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Trial record 25 of 112 for:    polycystic kidney disease

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02250287
First Posted: September 26, 2014
Last Update Posted: June 17, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sudhakar K. Venkatesh, M.D., Mayo Clinic
  Purpose

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
Autosomal Dominant Polycystic Kidney Disease Kidney Disease

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Sudhakar K. Venkatesh, M.D., Mayo Clinic:

Primary Outcome Measures:
  • 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.


Enrollment: 20
Study Start Date: December 2014
Study Completion Date: March 2016
Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02250287


Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Sudhakar Venkatesh, MD Mayo Clinic
  More Information

Responsible Party: Sudhakar K. Venkatesh, M.D., Primary Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02250287     History of Changes
Other Study ID Numbers: 14-000866
First Submitted: September 18, 2014
First Posted: September 26, 2014
Last Update Posted: June 17, 2016
Last Verified: May 2016

Keywords provided by Sudhakar K. Venkatesh, M.D., Mayo Clinic:
autosomal dominant polycystic kidney disease
magnetic resonance imaging parameters
magnetic resonance elastography
apparent diffusion coefficient
blood oxygen level determinations
diffusion weighted imaging

Additional relevant MeSH terms:
Kidney Diseases
Polycystic Kidney Diseases
Polycystic Kidney, Autosomal Dominant
Urologic Diseases
Kidney Diseases, Cystic
Abnormalities, Multiple
Congenital Abnormalities
Genetic Diseases, Inborn