Clinical Trial: Prolonged Gadolinium Retention After MRI Imaging
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
Official Title: Prolonged Gadolinium Retention After MRI Imaging in Patients With Normal Renal Function
Brief 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 Summary:
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:
- 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 .
- Evaluate levels of endogenous and xenobiotic metal levels and their relationship with gadolinium levels.
- Evaluate for symptoms of gadolinium toxicity.
Sponsor: Mt. Sinai Medical Center, Miami
Current Primary Outcome: gadolinium levels in urine before and after an edetate calcium disodium challenge [ Time Frame: within 6 months of a gadolinium-enhanced MRI ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Mt. Sinai Medical Center, Miami
Dates:
Date Received: April 15, 2015
Date Started: July 2017
Date Completion: December 2018
Last Updated: March 21, 2017
Last Verified: March 2017
