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it was logistically difficult to obtain the drug needed to conduct the study
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| edetate calcium disodium | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| edetate calcium disodium | Drug | All subjects will receive a 250 mL 5% dextrose intravenous infusion over 1 hour that contains 1 gr of edetate calcium disodium |
|
| Measure | Description | Time Frame |
|---|---|---|
| gadolinium levels in urine before and after an edetate calcium disodium challenge | within 6 months of a gadolinium-enhanced MRI |
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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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mount Sinai Medical Center | Miami Beach | Florida | 33140 | United States |
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| ID | Term |
|---|---|
| D000075322 | Heavy Metal Poisoning |
| ID | Term |
|---|---|
| D011041 | Poisoning |
| D064419 | Chemically-Induced Disorders |
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| ID | Term |
|---|---|
| D004369 | Pentetic Acid |
| D004492 | Edetic Acid |
| ID | Term |
|---|---|
| D011073 | Polyamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 |
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|
| Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D005029 | Ethylenediamines |
| D003959 | Diamines |