NCT02421029

Prolonged Gadolinium Retention After MRI Imaging

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

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Mt. Sinai Medical Center, Miami · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Heavy Metal Toxicity

Interventions

Type	Name	Description
DRUG	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

Timeline

• Start date: 2017-07-01
• Primary completion: 2018-12-01
• Completion: 2018-12-01
• First posted: 2015-04-20
• Last updated: 2017-08-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study