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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02421029
Study type Interventional
Source Mt. Sinai Medical Center, Miami
Contact
Status Withdrawn
Phase Phase 4
Start date July 2017
Completion date December 2018

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