Prolonged Gadolinium Retention After MRI Imaging

Mt. Sinai Medical Center, Miami

Status and phase: Withdrawn; Phase 4

Conditions: Heavy Metal Toxicity

Treatments: Drug: edetate calcium disodium

Study type: Interventional

Funder types: Other

Identifiers

NCT02421029

MRI-EDTA

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 20+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

edetate calcium disodium

Experimental group

Description:

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.

Treatment:

Drug: edetate calcium disodium