Prolonged Gadolinium Retention After MRI Imaging

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-31

Study Completion Date

2018-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Heavy Metal Toxicity

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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edetate calcium disodium

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.

Group Type EXPERIMENTAL

edetate calcium disodium

Intervention Type DRUG

All subjects will receive a 250 mL 5% dextrose intravenous infusion over 1 hour that contains 1 gr of edetate calcium disodium

Interventions

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edetate calcium disodium

All subjects will receive a 250 mL 5% dextrose intravenous infusion over 1 hour that contains 1 gr of edetate calcium disodium

Intervention Type DRUG

Other Intervention Names

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Calcium Disodium Versenate

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes