Autosomal Dominant Polycystic Kidney DiseaseMRI PilotNCT02250287
New Quantitive MRI Parameters in Assessing Kidneys of Autosomal Dominant Polycystic Kidney Disease
An observational study of Autosomal Dominant Polycystic Kidney Disease and Kidney Disease, run by Mayo Clinic at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Autosomal Dominant Polycystic Kidney Disease, Kidney Disease
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to Mar 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- 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.
Who may be able to join
- 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
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot and Feasibility Study: Evaluation of New Quantitative Magnetic Resonance Imaging Parameters in Assessing the 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.
- Keywords
- autosomal dominant polycystic kidney disease, magnetic resonance imaging parameters, magnetic resonance elastography, apparent diffusion coefficient, blood oxygen level determinations, diffusion weighted imaging
- Medical subject headings
- Polycystic Kidney, Autosomal Dominant, Kidney Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate renal tissue stiffness
The renal parenchymal tissue stiffness is measured in kilopascals with magnetic resonance elastography sequence.
Measured: baseline
Magnetization transfer ratio
The magnetization transfer ratio of renal tissue is measured with magnetization transfer sequence and expressed as a ratio.
Measured: 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).
Measured: 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.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2014 (estimated)
- Study startDec 2014
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autosomal Dominant Polycystic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sudhakar K. Venkatesh, M.D., Mayo Clinic
- Investigators
- Sudhakar Venkatesh, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02250287
- Sponsor's protocol ID
- 14-000866
- Acronym
- MRI Pilot
- Status last verified
- May 2016
- First submitted
- 18 Sep 2014
- Last updated
- 17 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot and Feasibility Study: Evaluation of New Quantitative Magnetic Resonance Imaging Parameters in Assessing the Kidneys of Autosomal Dominant Polycystic Kidney Disease
- ClinicalTrials.gov ID
- NCT02250287
- Acronym / sponsor ID
- MRI Pilot / 14-000866
- Keywords
- autosomal dominant polycystic kidney disease, magnetic resonance imaging parameters, magnetic resonance elastography, apparent diffusion coefficient, blood oxygen level determinations, diffusion weighted imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 26 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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.
Key inclusion criteria (7 listed)
- 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
- Male and female subjects between 18-30 years of age
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2016.
Related trials for Autosomal Dominant Polycystic Kidney Disease
RecruitingObservational study
Hypertension in Children and Young People at Risk of Autosomal Dominant Polycystic Kidney Disease
Autosomal Dominant Polycystic Kidney Disease (ADPKD
Active, not recruitingObservational study
Role of ROS and cAMP-PKA Biomarkers in ADPKD
Autosomal Dominant Polycystic Kidney Disease
Not yet recruitingPhase 1
A Study to Investigate the Pharmacokinetics of JMKX003142 in Healthy Participants and Participants With Hepatic Impairment
ADPKD (Autosomal Dominant Polycystic Kidney Disease), Renal Edema
RecruitingPhase 1
Absorption, Distribution, Metabolism, and Excretion of 14C-VX-407 After a Single Oral Dose
Autosomal Dominant Polycystic Kidney Disease (ADPKD)
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sudhakar Venkatesh, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autosomal Dominant Polycystic Kidney Disease and Kidney Disease, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate renal tissue stiffness (time frame: baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2016.