Prolonged Gadolinium Retention After MRI Imaging

Study Overview
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Brief Summary
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The researchers propose to investigate the prevalence of gadolinium in the urine of patients with a prior gadolinium-enhanced MRI before and after a edetate calcium disodium challenge. Moreover, will investigate if there is any correlation of gadolinium urine levels with levels of endogenous (e.g zinc) and xenobiotic metals.

Detailed Description
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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.

Official Title
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Prolonged Gadolinium Retention After MRI Imaging in Patients With Normal Renal Function

Conditions
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Heavy Metal Toxicity

Intervention / Treatment
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* Drug: edetate calcium disodium


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: edetate calcium disodium<br>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. | Drug: edetate calcium disodium<br>* All subjects will receive a 250 mL 5% dextrose intravenous infusion over 1 hour that contains 1 gr of edetate calcium disodium<br>* Other names: Calcium Disodium Versenate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| gadolinium levels in urine before and after an edetate calcium disodium challenge |  | within 6 months of a gadolinium-enhanced MRI | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gadolinium, calcium disodium ethylenediaminetetraacetic acid (EDTA), heavy metal toxicity