Renal Dysfunction
Conditions
Keywords
Magnetic Resonance Imaging, Contrast Agent, Gadoterate
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.
Interventions
DRUGGadoterate
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).
OTHERNo 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).
Sponsors
Guerbet
Loyola University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Glomerular Filtration Rate (GFR) | 72 hours | Change in GFR from 0 to 72 hours |
Countries
United States
Participant flow
Recruitment details
Recruitment began on November 5, 2014 and ended on May 15, 2019
Participants by arm
| Arm | Count |
|---|---|
| No Gadoterate 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). | 13 |
| Gadoterate 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). | 33 |
| Total | 46 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 2 |
Baseline characteristics
| Characteristic | No Gadoterate | Gadoterate | Total |
|---|---|---|---|
| Age, Continuous | 57.2 years | 64.2 years | 59.5 years |
| Body Mass Index | 30.5 kg/m^2 | 28.6 kg/m^2 | 29.6 kg/m^2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 5 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants | 28 Participants | 40 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 5 Participants | 11 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) White | 7 Participants | 23 Participants | 30 Participants |
| Region of Enrollment United States | 13 Participants | 33 Participants | 46 Participants |
| Sex: Female, Male Female | 5 Participants | 16 Participants | 21 Participants |
| Sex: Female, Male Male | 8 Participants | 17 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 5 / 33 |
| other Total, other adverse events | 0 / 13 | 0 / 33 |
| serious Total, serious adverse events | 0 / 13 | 5 / 33 |
Outcome results
Primary
Change in Glomerular Filtration Rate (GFR)
Change in GFR from 0 to 72 hours
Time frame: 72 hours
Population: The analysis population includes all participants with a baseline and 72-hour follow-up GFR assessment
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| No Gadoterate | Change in Glomerular Filtration Rate (GFR) | 1.5 ml/minute |
| Gadoterate | Change in Glomerular Filtration Rate (GFR) | 1.0 ml/minute |