Prolonged Gadolinium Retention After MRI Imaging

Withdrawn before enrolling · Phase 4

Conditions studied: Heavy Metal Toxicity

In brief

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.

Key facts

Study ID

NCT02421029

Run by

Mt. Sinai Medical Center, Miami

People needed

0

Starts

2017-07-01

Expected to finish

2018-12-01

Last updated by the study team

2017-08-29

Who can join

Age: 20 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Mount Sinai Medical Center — Miami Beach, Florida, United States

Full record on ClinicalTrials.gov

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