New Quantitive MRI Parameters in Assessing Kidneys of Aut... | NCT02250287

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

NCT02250287

Sponsor

Mayo Clinic

Status

Completed

Last Update Posted

Jun 17, 2016Estimated

Enrollment

20Actual

Phase

Not provided

Conditions

Autosomal Dominant Polycystic Kidney Disease
Kidney Disease

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2014

Primary Completion Date

Mar 2016Actual

Completion Date

Mar 2016Actual

First Submitted Date

Sep 18, 2014

First Submission Date that Met QC Criteria

Sep 24, 2014

First Posted Date

Sep 26, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 16, 2016

Last Update Posted Date

Jun 17, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

30 Years

Standard Ages

Adult

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.

Sampling Method

Non-Probability Sample

ID	Term
D016891	Polycystic Kidney, Autosomal Dominant
D007674	Kidney Diseases

ID	Term
D007690	Polycystic Kidney Diseases
D052177	Kidney Diseases, Cystic
D014570	Urologic Diseases
D052776	Female Urogenital Diseases