New Quantitive MRI Parameters in Assessing Kidneys of Autosomal Dominant Polycystic Kidney Disease
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 14-000866
NCT ID: NCT02250287
Sponsor Protocol Number: 14-000866
About this study
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.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential 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
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Sudhakar Venkatesh, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available