Heavy Metal ToxicityPhase 4NCT02421029
Prolonged Gadolinium Retention After MRI Imaging
A Phase 4 study testing edetate calcium disodium in people with Heavy Metal Toxicity, run by Mt. Sinai Medical Center, Miami at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heavy Metal Toxicity
- What is being tested?
- edetate calcium disodium
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2017to Dec 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- Diseases of copper, iron, or calcium metabolism
- Women of child-bearing potential
- History of lead intoxication; lead encephalopathy; cerebral edema.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mount Sinai Medical Center
Miami Beach, Florida, 33140
About this study
Official title: Prolonged Gadolinium Retention After MRI Imaging in Patients With Normal Renal Function
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.
Read the 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:
- 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.
- Conditions
- Heavy Metal Toxicity
- Being tested
- edetate calcium disodium
- Keywords
- gadolinium, calcium disodium ethylenediaminetetraacetic acid (EDTA), heavy metal toxicity
- Medical subject headings
- Heavy Metal Poisoning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
edetate calcium disodiumDrug
Also called Calcium Disodium Versenate
All subjects will receive a 250 mL 5% dextrose intravenous infusion over 1 hour that contains 1 gr of edetate calcium disodium
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: edetate calcium disodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
gadolinium levels in urine before and after an edetate calcium disodium challenge
Measured: within 6 months of a gadolinium-enhanced MRI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2015 (estimated)
- Study startJul 2017 (estimated)
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Why it stopped: it was logistically difficult to obtain the drug needed to conduct the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heavy Metal ToxicityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mt. Sinai Medical Center, Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gervasio Lamas, MD, Mt. Sinai Medical Center, Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02421029
- Sponsor's protocol ID
- MRI-EDTA
- Status last verified
- Aug 2017
- First submitted
- 15 Apr 2015
- Last updated
- 29 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prolonged Gadolinium Retention After MRI Imaging in Patients With Normal Renal Function
- ClinicalTrials.gov ID
- NCT02421029
- Acronym / sponsor ID
- MRI-EDTA
- Conditions
- Heavy Metal Toxicity
- Keywords
- gadolinium, calcium disodium ethylenediaminetetraacetic acid (EDTA), heavy metal toxicity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: it was logistically difficult to obtain the drug needed to conduct the study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mt. Sinai Medical Center, MiamiUniversity, hospital or other
- Study start
- Jul 2017 (estimated)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 20 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| edetate calcium disodium | Experimental | Drug: edetate calcium disodiumSubjects 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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| edetate calcium disodiumAlso: Calcium Disodium VersenateAll subjects will receive a 250 mL 5% dextrose intravenous infusion over 1 hour that contains 1 gr of edetate calcium disodium | Drug | edetate calcium disodium |
Primary outcome
gadolinium levels in urine before and after an edetate calcium disodium challenge
Time frame: within 6 months of a gadolinium-enhanced MRI
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing edetate calcium disodium in people with Heavy Metal Toxicity, run by Mt. Sinai Medical Center, Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 29 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
gadolinium levels in urine before and after an edetate calcium disodium challenge (time frame: within 6 months of a gadolinium-enhanced MRI). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2017.