Clinical trial 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
ClinicalTrials.gov ID: NCT04373564
What this study is testing
What is Gadoxetate disodium?
an investigational gadolinium‑based contrast agent being studied for its potential impact on motor and cognitive function in adults undergoing repeated imaging. is designed to improve MRI images by altering the magnetic properties of nearby water molecules in the body.
Also referred to as Eovist, Primovist, BAY86-4873.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to find out whether gadolinium‑based contrast agents given multiple times over five years change a person’s body movement or mental abilities.
- Who it's for
- Adults 18‑65 who need at least one MRI or similar imaging test each year.
- What's involved
- Participants will receive an MRI or other imaging test with the contrast dye each year and will have physical exams, lab work, and tests of movement and mental skills at study visits.
- Time commitment
- The study lasts five years with at least seven doctor visits for exams and tests.
- Phase 4: studies an already-approved treatment
- Time commitment: about 5 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 64
You may be able to join if
- Participant must be neurologically normal, defined as free of unstable neurologic and psychiatric disease as confirmed by a normal neurologic...
- Participant (GBCA-exposed or controls) agrees to undergo unenhanced magnetic resonance imaging (UE-MRI) of the brain at enrollment and at the end of...
- Each participant should be likely to undergo ≥5 GBCA-enhanced MR examinations with the same GBCA at least annually throughout the 5-year study...
- Participants who never had and are not likely to receive any GBCA injection during the course of the study
- Each control participant must be willing to undergo UE-MRI of the brain at baseline and at Year 5.
You likely can't join if
- As evidenced by history or determined in the neurologic exam at screening, concurrent neurological and/or psychiatric disease (or treatments) that...
- Prior, planned, or ongoing chemotherapy or brain irradiation
- Use of concomitant medication(s) affecting neuro-cognitive or motor function
- Substance or alcohol abuse as determined by the investigator
- Alcoholic cirrhosis
- Renal disease, defined as estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73 m2
See the full eligibility criteria
- 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 enrollment and at the end of the observation period (5 years)
- 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
- Participants who never had and are not likely to receive any GBCA injection during the course of the study
- Each control participant must be willing to undergo UE-MRI of the brain at baseline and at Year 5.
- As evidenced by history or determined in the neurologic exam at screening, concurrent neurological and/or psychiatric disease (or treatments) that could influence the results of the study's motor and cognitive tests...
- Prior, planned, or ongoing chemotherapy or brain irradiation
- Use of concomitant medication(s) affecting neuro-cognitive or motor function
- Substance or alcohol abuse as determined by the investigator
- 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]...
- Clinical indications requiring \>1 contrast enhanced magnetic resonance imaging (CE-MRI) every 6 months
- Pregnant or nursing (lactating) women
- Participants with any previous exposure to a GBCA.
- Participants with any contraindication to UE-MRI examinations.
The study team makes the final eligibility decision.
Where it is enrolling
- Scottsdale, Arizona, United States
- Chicago, Illinois, United States
- Peoria, Illinois, United States
- Boston, Massachusetts, United States
- Hershey, Pennsylvania, United States
- Philadelphia, Pennsylvania, United States
- Dallas, Texas, United States
- Madison, Wisconsin, United States
- Passo Fundo, Rio Grande do Sul, Brazil
- Porto Alegre, Rio Grande do Sul, Brazil
- São José do Rio Preto, São Paulo, Brazil
- São Paulo, São Paulo, Brazil
- Strasbourg, France
- Berlin, Germany
- Siena, Siena, Italy
- Trieste, Trieste, Italy
- Milan, Italy
- Roma, Italy
- Verona, Italy
- Seongnam-si, Gyeonggi-do, South Korea
+ 3 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 5 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Scottsdale, Arizona, United States; Chicago, Illinois, United States; Peoria, Illinois, United States; Boston, Massachusetts, United States; Hershey, Pennsylvania, United States; Philadelphia, Pennsylvania, United States and 17 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.