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Evaluation of Gadoterate in Patients With Decreased Kidney Function

Primary Purpose

Renal Dysfunction

Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Gadoterate
No Gadoterate
Sponsored by
Loyola University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Renal Dysfunction focused on measuring Magnetic Resonance Imaging, Contrast Agent, Gadoterate

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Loyola University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Gadoterate

No Gadoterate

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

Change in glomerular filtration rate (GFR)
Change in GFR from 0 to 6 months

Secondary Outcome Measures

Full Information

First Posted
February 27, 2015
Last Updated
June 5, 2019
Sponsor
Loyola University
Collaborators
Guerbet
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1. Study Identification

Unique Protocol Identification Number
NCT02382380
Brief Title
Evaluation of Gadoterate in Patients With Decreased Kidney Function
Official Title
Evaluation of Gadoterate in Patients With Renal Dysfunction
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 2015 (Actual)
Primary Completion Date
October 2019 (Anticipated)
Study Completion Date
July 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Loyola University
Collaborators
Guerbet

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Dysfunction
Keywords
Magnetic Resonance Imaging, Contrast Agent, Gadoterate

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gadoterate
Arm Type
Experimental
Arm Description
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).
Arm Title
No Gadoterate
Arm Type
Other
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Gadoterate
Other Intervention Name(s)
Dotarem
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
No Gadoterate
Intervention Description
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).
Primary Outcome Measure Information:
Title
Change in glomerular filtration rate (GFR)
Description
Change in GFR from 0 to 6 months
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ari Goldberg, MD
Organizational Affiliation
Loyola University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States

12. IPD Sharing Statement

Citations:
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17061066
Citation
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PubMed Identifier
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Citation
Perazella MA. Current status of gadolinium toxicity in patients with kidney disease. Clin J Am Soc Nephrol. 2009 Feb;4(2):461-9. doi: 10.2215/CJN.06011108. Erratum In: Clin J Am Soc Nephrol. 2009 Apr;4(4):866.
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Evaluation of Gadoterate in Patients With Decreased Kidney Function

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