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Prolonged Gadolinium Retention After MRI Imaging

Information source: Mt. Sinai Medical Center, Miami
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Heavy Metal Toxicity

Intervention: edetate calcium disodium (Drug)

Phase: Phase 4

Status: Not yet recruiting

Sponsored by: Mt. Sinai Medical Center, Miami

Overall contact:
Gervasio A Lamas, MD, Phone: 305-674-2162, Email: gervasio.lamas@msmc.com

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.

Clinical Details

Official title: Prolonged Gadolinium Retention After MRI Imaging in Patients With Normal Renal Function

Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Primary outcome: gadolinium levels in urine before and after an edetate calcium disodium challenge

Detailed 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.

Eligibility

Minimum age: 20 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Gervasio A Lamas, MD, Phone: 305-674-2162, Email: gervasio.lamas@msmc.com

Mount Sinai Medical Center, Miami Beach, Florida 33140, United States; Not yet recruiting
Gervasio A Lamas, MD, Phone: 305-674-2162, Email: Gervasio.Lamas@msmc.com
Ivan Arenas, MD, Phone: 305-496-4376, Email: Ivan.Arenas@msmc.com
Additional Information

Starting date: June 2015
Last updated: April 17, 2015

Page last updated: August 23, 2015

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