Prolonged Gadolinium Retention After MRI Imaging
- Registration Number
- NCT02421029
- Lead Sponsor
- Mt. Sinai Medical Center, Miami
- 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 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
• 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description edetate calcium disodium 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.
- Primary Outcome Measures
Name Time Method gadolinium levels in urine before and after an edetate calcium disodium challenge within 6 months of a gadolinium-enhanced MRI
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Mount Sinai Medical Center
🇺🇸Miami Beach, Florida, United States