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Miami Beach, Florida 33140


Purpose:

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.


Study summary:

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.


Criteria:

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.


NCT ID:

NCT02421029


Primary Contact:

N/A


Backup Contact:

N/A


Location Contact:

Miami Beach, Florida 33140
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 21, 2017

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