Comparing 3 approaches for motor function
Official title: Effect on Body Movement and Mental Skills in Patients Who Received Gadolinium-based Contrast Media for Magnetic Resonance Examination Multiple Times Within 5 Years
Prospective Evaluation of Potential Effects of Repeated Gadolinium-based Contrast Agent (GBCA) Administrations of the Same GBCA on Motor and Cognitive Functions in Neurologically Normal Adults in Comparison to a Non-GBCA Exposed Control Group
- Phase 4
- 3 groups
- One site, in Burlington
- Recruiting
Interventions (10)
- Medical procedure
Motor Tests
To assess motor function annually
- Medical procedure
Cognitive Tests
To assess cognitive function annually
- Medical procedure
Unenhanced-MRI of the brain
The UE-MRI of the brain will be performed at baseline and at the year 5 visit in order to exclude presence of a significant MRI abnormality
- Medical procedure
Gadolinium Measurements
Blood samples and spontaneous urine specimens will be collected through the course of the study to measure Gd concentration
- Medication
Gadoxetate disodium
Administered as defined by the treating physician as part of routine clinical practice
- Medication
Gadobenate dimeglumine
Administered as defined by the treating physician as part of routine clinical practice
- Medication
Gadodiamide
Administered as defined by the treating physician as part of routine clinical practice
- Medication
Gadoterate meglumine
Administered as defined by the treating physician as part of routine clinical practice
- Medication
Gadobutrol
Administered as defined by the treating physician as part of routine clinical practice
- Medication
Gadoteridol
Administered as defined by the treating physician as part of routine clinical practice
Canadian Sites (1)
1 listed, none recruiting
- Withdrawn
G. Kenneth Jansz Medical Professional Corporation
Burlington, Ontario
Eligibility Criteria
See who this study is looking for24 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Each controlControl groupThe group a new treatment is measured against.Read more → participant must be willing to undergo UE-MRI of the brain at baselineBaselineYour starting measurements, taken before treatment begins.Read more → and at Year 5. In Years 1 to 4, the control participants will undergo their clinically indicated UE-MRIs, computed tomography (CT), ultrasound, or X-ray procedures
- +Participants should have at least 1 of the following indications: a) Medium to high risk for breast cancer or dense breasts undergoing breast cancer screeningScreeningThe checks done before joining, to see whether a study fits.Read more → with MRI, b) Elevated prostate-specific antigen (PSA) and under active diagnostic surveillance for prostate cancer, c) Chronic liver disease (eg, liver cirrhosis limited to Child class A, post-hepatitis chronic hepatopathy, or primary sclerosing cholangitis) for surveillance of hepatocellular carcinoma development, d) Low-grade colorectal cancer or neuroendocrine tumor undergoing screening for liver metastases or e) Branch-duct intraductal papillary mucinous neoplasm (IPMN) of the pancreas (maximum size ≤2 cm) undergoing imaging surveillance.
- +Participant must be neurologically normal, defined as free of unstable neurologic and psychiatric disease as confirmed by a normal neurologic examination at screening
- +Participant (GBCA-exposed or controls) agrees to undergo unenhanced magnetic resonance imaging (UE-MRI) of the brain at enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more → and at the end of the observation period (5 years)
- +In addition, for participants in the GBCA ArmsArmOne of the groups in a study, each receiving something different.Read more → only:
- +Each participant should be likely to undergo ≥5 GBCA-enhanced MR examinations with the same GBCA at least annually throughout the 5-year study duration
- +Prospective participants with up to 3 well documented GBCA administrations prior to study screening are acceptable, provided that the imaging was performed with the same GBCA as the one to be prospectively used in the study. If the GBCA used cannot be identified, he/she cannot be enrolled.
- +For the Control Arm:
- +Participants who never had and are not likely to receive any GBCA injection during the course of the study
Exclusion
- −Use of concomitant medication(s) affecting neuro-cognitive or motor function
- −Substance or alcohol abuse as determined by the investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →
- −Alcoholic cirrhosis
- −Renal disease, defined as estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73 m2
- −History of environmental/occupational/other exposure to one or more chemicals that may affect cognitive and/or motor function, including, but not limited to, heavy metals (arsenic \[As\], cadmium \[Cd\], lead \[Pb\], manganese \[Mn\], and mercury \[Hg\]), pesticides, solvents, or carbon monoxide.
- −Clinical indications requiring \>1 contrast enhanced magnetic resonance imaging (CE-MRI) every 6 months
- −Presence of any metal-containing joint implants/prostheses
- −In addition, for participants in either of the GBCA ArmsArmOne of the groups in a study, each receiving something different.Read more → only:
- −\- Receipt of a GBCA or generic prior to study entry other than the specific GBCA to be administered during the course of the study.
- −For participants in the Control ArmControl groupThe group a new treatment is measured against.Read more → only:
- −Participants with any previous exposure to a GBCA.
- −Participants with any contraindication to UE-MRI examinations.
- −Pregnant or nursing (lactating) women
- −As evidenced by history or determined in the neurologic exam at screeningScreeningThe checks done before joining, to see whether a study fits.Read more →, concurrent neurological and/or psychiatric disease (or treatments) that could influence the results of the study's motor and cognitive tests (e.g. Cerebrovascular disease, Multiple sclerosis, Neurodegenerative disease, Malignant disease other than listed in indications, Carcinoid tumors, Epilepsy, Prior neurosurgery, Psychotic disorders or any prior psychotic episode not otherwise specified - any documented prior history of chronic schizophrenia, Remittent or current medically confirmed major depressive disorder or bipolar disorder, History of long-term major depression or bipolar affective disorder with an active episode in the past 2 to 5 years, Neurodevelopmental disorders (eg, trisomy 21), Uncontrolled severe migraine, Uncontrolled or controlled anxiety or depression within 6 months before enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more →, Screening scores of ≤24 on the MMSE and/or ≥11 on the Hospital Anxiety and Depression Scale (HADS)).
- −Prior, planned, or ongoing chemotherapy or brain irradiation
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study does not fall into the standard research categories.
Phase 4Phase 4A study of a treatment that is already approved and in use.Read more → — a study of a treatment already approved for use, following it in everyday practice.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 3 groups in this study.
Group A receives one or more of: Motor Tests, Cognitive Tests, Unenhanced-MRI of the brain, Gadolinium Measurements, Gadoxetate disodium, Gadobenate dimeglumine and Gadodiamide.
Registry label: A: Linear GBCAs
Group B receives one or more of: Motor Tests, Cognitive Tests, Unenhanced-MRI of the brain, Gadolinium Measurements, Gadoterate meglumine, Gadobutrol and Gadoteridol.
Registry label: B: Macrocyclic GBCAs
Group C receives one or more of: Motor Tests, Cognitive Tests, Unenhanced-MRI of the brain and Gadolinium Measurements.
Registry label: C: No GBCA (Control arm)
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Groups are assigned by the study team using set rules, rather than by chance.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists an age range of 18 years to 64 years.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 2,076 people.
The study is currently expected to finish around December 2028.
The main measurement is taken over: At baselineBaselineYour starting measurements, taken before treatment begins.Read more →, year 5.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Change of motor function from baselineBaselineYour starting measurements, taken before treatment begins.Read more → to year 5 in comparison to a matched non-GBCA-exposed control groupControl groupThe group a new treatment is measured against.Read more → — measured over At baseline, year 5.
Change in cognitive function from baseline to year 5 in comparison to a matched non-GBCA-exposed control group — measured over At baseline, year 5.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT04373564 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Motor TestsProcedure
To assess motor function annually
From the trial registry — its own words, unedited.
What a procedure is here: A surgery, technique or clinical procedure being studied.
Read the full explanation → · in clinical review
About Cognitive TestsProcedure
To assess cognitive function annually
From the trial registry — its own words, unedited.
What a procedure is here: A surgery, technique or clinical procedure being studied.
Read the full explanation → · in clinical review
About Unenhanced-MRI of the brainProcedure
The UE-MRI of the brain will be performed at baseline and at the year 5 visit in order to exclude presence of a significant MRI abnormality
From the trial registry — its own words, unedited.
What a procedure is here: A surgery, technique or clinical procedure being studied.
Read the full explanation → · in clinical review
About Gadolinium MeasurementsProcedure
Blood samples and spontaneous urine specimens will be collected through the course of the study to measure Gd concentration
From the trial registry — its own words, unedited.
What a procedure is here: A surgery, technique or clinical procedure being studied.
Read the full explanation → · in clinical review
About Gadoxetate disodiumDrug
Administered as defined by the treating physician as part of routine clinical practice
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About Gadobenate dimeglumineDrug
Administered as defined by the treating physician as part of routine clinical practice
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About GadodiamideDrug
Administered as defined by the treating physician as part of routine clinical practice
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About Gadoterate meglumineDrug
Administered as defined by the treating physician as part of routine clinical practice
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About GadobutrolDrug
Administered as defined by the treating physician as part of routine clinical practice
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About GadoteridolDrug
Administered as defined by the treating physician as part of routine clinical practice
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 18 years to 64 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
Groups are assigned by the study team using set rules, rather than by chance.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 18 years to 64 years.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: At baselineBaselineYour starting measurements, taken before treatment begins.Read more →, year 5.
The study as a whole is currently expected to finish around 2028-12-31.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 2,076 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: Burlington, Ontario, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
This study is a postmarketing requirement jointly carried out by four NDA holders (Bayer AG, Bracco, GE Healthcare and Guerbet) and the CRO IQVIA. The study aims to create detailed images of the organs and tissue of the human body during x-ray, CT-scan or MRI investigations, doctors are using contrast media (a kind of dye) which can be given to patients by injection into a blood vessel or by mouth. In this study researchers want to find out whether so called gadolinium-based contrast agents (GBCAs) have an effect on body movement and mental skills when given to participants multiple times within 5 years. The study plans to enroll about 2076 participants suffering from a condition for which they are likely to have at least annually a MRI or another imaging examinations. Only adults up to 65 years will be considered to join this study. During the study duration of 5 years participants will receive annually a MRI or other imaging tests (such as CT-scan, x-ray) and will visit the study doctor at least 7 times for physical examinations, laboratory investigations and tests on body movement and mental skills.
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.