Heavy Metal Toxicity
Conditions
Keywords
gadolinium, calcium disodium ethylenediaminetetraacetic acid (EDTA), heavy metal toxicity
Brief summary
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
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: 1. 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 . 2. Evaluate levels of endogenous and xenobiotic metal levels and their relationship with gadolinium levels. 3. Evaluate for symptoms of gadolinium toxicity.
Interventions
All subjects will receive a 250 mL 5% dextrose intravenous infusion over 1 hour that contains 1 gr of edetate calcium disodium
Sponsors
Mt. Sinai Medical Center, Miami
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| gadolinium levels in urine before and after an edetate calcium disodium challenge | within 6 months of a gadolinium-enhanced MRI |
Countries
United States
Outcome results
None listed