Prolonged Gadolinium Retention After MRI Imaging

NCT02421029 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: MRI-EDTA
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Heavy Metal Toxicity

Keywords

gadolinium; calcium disodium ethylenediaminetetraacetic acid (EDTA); heavy metal toxicity

Outcome Measures

Primary Outcomes (1)

• gadolinium levels in urine before and after an edetate calcium disodium challenge

  within 6 months of a gadolinium-enhanced MRI

Study Arms (1)

edetate calcium disodium

EXPERIMENTAL

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.

Drug: edetate calcium disodium

Interventions

edetate calcium disodium DRUG

All subjects will receive a 250 mL 5% dextrose intravenous infusion over 1 hour that contains 1 gr of edetate calcium disodium

Also known as: Calcium Disodium Versenate

edetate calcium disodium

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mt. Sinai Medical Center, Miami: lead

Study Sites (1)

Mount Sinai Medical Center

Miami Beach, Florida, 33140, United States

Location

MeSH Terms

Conditions

Heavy Metal Poisoning

Interventions

Pentetic Acid; Edetic Acid

Condition Hierarchy (Ancestors)

Poisoning; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Polyamines; Amines; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Ethylenediamines; Diamines

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair, Department of Medicine

Study Record Dates

• First Submitted: April 15, 2015
• First Posted: April 20, 2015
• Study Start: July 1, 2017
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: August 29, 2017

Record last verified: 2017-08

Locations

US (1)