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

  • Study type

    Observational
  • Study IDs

  • Describes 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.
  • 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. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

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 us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Paul Jannetto, Ph.D.

Open for enrollment

Contact information:

Katelyn Reed

(507)284-0503

Reed.Katelyn@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20456571

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