A Study of Three-Dimensional Ultrasound Imaging for Measurement of Total Kidney Volume and Renal Blood Flow
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: 18-010292
Sponsor Protocol Number: 18-010292
About this study
The primary purpose of this study is to measure total kidney volume (TKV) from multi-sweep freehand 3D US using a Philips EPIQ scanner with a 2D curved array C5-1 probe and an electromagnetic (EM) orientation tracker attached to the probe, and from panoramic 3D using X6-1 matrix probe. To segment the kidney from US volume in a fully automated manner, we will use deep learning approaches. We will also use MR-based measurements of TKV as the gold standard by which we will evaluate the accuracy of the US based measurements.
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:
- Male and female subjects between 0 and 99 years of age.
- Adult participants who are ADPKD affected.
- Pediatric participants ADPKD affected or siblings unaffected or affected unknown.
- Adult participants must have been scheduled for an MRI exam. Concomitant MRI imaging is not required for pediatric patients under this protocol.
- Ability to provide written, informed consent prior to initiation of any study-related procedures, and ability, in the opinion of the principle investigator, to comply with all requirements of the study.
Exclusion Criteria:
- Female subjects that are pregnant.
Eligibility last updated 10/22/21. Questions regarding updates should be directed to the study team contact.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
More information
Publications
Publications are currently not available