Prolonged Gadolinium Retention After MRI Imaging

Heavy Metal Toxicity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02421029
• Other study ID #: MRI-EDTA
• Status: Withdrawn
• Phase: Phase 4
• First received: April 15, 2015
• Last updated: August 28, 2017
• Start date: July 2017
• Est. completion date: December 2018

Study information

• Verified date: August 2017
• Source: Mt. Sinai Medical Center, Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Heavy Metal Toxicity
• Poisoning

Intervention

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

Locations

Country	Name	City	State
United States	Mount Sinai Medical Center	Miami Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Mt. Sinai Medical Center, Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	gadolinium levels in urine before and after an edetate calcium disodium challenge		within 6 months of a gadolinium-enhanced MRI