Prolonged Gadolinium Retention After MRI Imaging

• Status: Withdrawn
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Mt. Sinai Medical Center, Miami
• Treatments: Calcium; Calcium, Dietary; Edetic Acid; Pentetic Acid

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.