Evaluation of Gadoterate in Patients With Decreased Kidney Function

June 5, 2019 updated by: Ari Goldberg, Loyola University

Evaluation of Gadoterate in Patients With Renal Dysfunction

This study is for individuals with decreased kidney function whose doctor has ordered Magnetic Resonance Imaging (MRI). Because kidney function is decreased, these patients usually do not receive the intravenous contrast material that can improve the accuracy of the MRI findings. The purpose of this study is to evaluate the safety and benefit of using a contrast material called Gadoterate in patients with decreased kidney function.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Gadolinium-based intravenous contrast agents are widely used for the enhancement of MRI findings. However, these agents have been implicated in varying degrees of nephrotoxicity and therefore are not usually used in patients with renal dysfunction. Gadoterate is a Gadolinium agent and previous studies have indicated that it is safe in patients with decreased kidney function. The purpose of this study is to evaluate the safety and efficacy of using Gadoterate in this patient population.

Participants who have been scheduled for an MRI will choose to either receive Gadoterate contrast as part of their MRI or not receive Gadoterate as part of their MRI.

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Maywood, Illinois, United States, 60153
        • Loyola University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Glomerular filtration rates (GFR) less than 30 ml/min but not on dialysis
  • Being sent for an MRI examination in the course of routine clinical evaluation of one of the following indications: suspected or known head/neck/brain mass, hepatic mass, renal mass, pancreatic mass, or prostate mass, as well as evaluation of carotid or abdominopelvic vasculature.

Exclusion Criteria:

  • Pregnant and lactating females
  • Planned initiation of chemotherapy or surgery within 72 hours of the MRI exam
  • Hemodynamic instability or acute coronary syndrome
  • History of nephrotoxic medication within 2 weeks of the exam
  • Less than 18 years old

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Gadoterate
Patients who choose to receive Gadoterate will receive an MRI exam with standard pre-contrast and Gadoterate-enhanced acquisitions (0.2 mL/kg). The MRI protocol utilized in the study will be comprised of the standard Body protocols (routine abdomen, liver-pancreas, renal, prostate, angiography) as well as the standard Neurologic exam protocols (routine brain, orbital, brainstem, neck, angiography).
Drug: Gadoterate
Patients who choose to receive Gadoterate will receive an MRI exam with standard pre-contrast and Gadoterate-enhanced acquisitions (0.2 mL/kg). The MRI protocol utilized in the study will be comprised of the standard Body protocols (routine abdomen, liver-pancreas, renal, prostate, angiography) as well as the standard Neurologic exam protocols (routine brain, orbital, brainstem, neck, angiography).
Other Names:
  • Dotarem
Other: No Gadoterate
Patients who choose not to receive Gadoterate will receive an MRI exam with no Gadolinium contrast. MRI protocols utilized in the study will be comprised of the standard Body protocols (routine abdomen, liver-pancreas, renal, prostate, angiography) as well as the standard Neurologic exam protocols (routine brain, orbital, brainstem, neck, angiography).
Other: No Gadoterate
Patients who choose not to receive Gadoterate will receive an MRI exam with no Gadolinium contrast. The MRI protocol utilized in the study will be comprised of the standard Body protocols (routine abdomen, liver-pancreas, renal, prostate, angiography) as well as the standard Neurologic exam protocols (routine brain, orbital, brainstem, neck, angiography).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in glomerular filtration rate (GFR)
Time Frame: 6 months
Change in GFR from 0 to 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Loyola University

Collaborators

Guerbet

Investigators

  • Principal Investigator: Ari Goldberg, MD, Loyola University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2015

Primary Completion (Anticipated)

October 1, 2019

Study Completion (Anticipated)

July 1, 2020

Study Registration Dates

First Submitted

February 27, 2015

First Submitted That Met QC Criteria

March 3, 2015

First Posted (Estimate)

March 6, 2015

Study Record Updates

Last Update Posted (Actual)

June 7, 2019

Last Update Submitted That Met QC Criteria

June 5, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 206338

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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