- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02421029
Prolonged Gadolinium Retention After MRI Imaging
Prolonged Gadolinium Retention After MRI Imaging in Patients With Normal Renal Function
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The investigators propose to enroll 20 volunteers in this pilot study, including males older than 20 years and postmenopausal women in two groups: Group 1: Individuals who had a gadolinium-enhanced MRI study within 1-4 weeks before participation and Group 2: Individuals who had gadolinium-enhanced MRI study within 3-6 months before enrollment. The results will inform future analyses of gadolinium retention, excretion, and potential symptoms associated with same.
Thus, the specific aims of this cross sectional study are to:
- Evaluate levels of gadolinium in the urine of adults with normal kidney function and a prior MRI performed within 6 months at baseline, and after a single dose of edetate calcium disodium .
- Evaluate levels of endogenous and xenobiotic metal levels and their relationship with gadolinium levels.
- Evaluate for symptoms of gadolinium toxicity.
Study Type
Phase
- Phase 4
Contacts and Locations
Study Locations
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Florida
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Miami Beach, Florida, United States, 33140
- Mount Sinai Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
• Subjects who had a contrast enhanced MRI for any indication within 1-4 weeks or 3-6 months, and normal renal function assessed by normal glomerular filtration rate (GFR) >60 mL/min/1.73 m2 at the time of the gadolinium-enhanced MRI study.
Exclusion Criteria:
- Allergy to edetate calcium disodium
- Prior chelation therapy with edetate disodium since the administration of gadolinium
- Blood pressure >160/100
- No venous access
- Platelet count <100,000/mm3
- Liver disease or alanine transaminase (ALT) or aspartate transaminase (AST) >2.0 times the upper limit of normal
- Diseases of copper, iron, or calcium metabolism
- Women of child-bearing potential
- History of lead intoxication; lead encephalopathy; cerebral edema.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: edetate calcium disodium
Subjects who had a gadolinium-enhanced MRI within 1-4 weeks or within 3-6 months before enrollment will receive a single dose of edetate calcium disodium to evaluate levels of gadolinium in their urine, pre and post infusion.
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All subjects will receive a 250 mL 5% dextrose intravenous infusion over 1 hour that contains 1 gr of edetate calcium disodium
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
gadolinium levels in urine before and after an edetate calcium disodium challenge
Time Frame: within 6 months of a gadolinium-enhanced MRI
|
within 6 months of a gadolinium-enhanced MRI
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Chemically-Induced Disorders
- Poisoning
- Heavy Metal Poisoning
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Protective Agents
- Bone Density Conservation Agents
- Calcium-Regulating Hormones and Agents
- Anticoagulants
- Antidotes
- Chelating Agents
- Sequestering Agents
- Iron Chelating Agents
- Calcium Chelating Agents
- Calcium
- Calcium, Dietary
- Edetic Acid
- Pentetic Acid
Other Study ID Numbers
- MRI-EDTA
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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