A Study to Determine Serum and Urine Reference Ranges in Patients with Normal Renal Function Being Administered Gadobutrol for an Enhanced Magnetic Resonance Imaging (MRI)
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: 18-007387
Sponsor Protocol Number: 18-007387
About this study
The primary purpose of this study is to determine the serum and urine gadolinium reference ranges in patients with normal renal function being administered Gadobutrol for an enhanced MRI exam.
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:
- Adults 18 years or older.
- Normal renal function:
- Serum creatinine <1.4 mg/dL; or
- Glomerular filtration rate; ≥60 mL/min.
- No gadolinium-enhanced MRI in last 6 months.
- Scheduled to undergo a gadobutrol-enhanced MRI and willing to come back for blood and urine collections at various time points (e.g. pre-MRI and 1, 3, 7, 14, 28, 56, and 84 days post-MRI.
Exclusion Criteria:
- Any of the above criteria not met.
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 Paul Jannetto, Ph.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available