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New treatment option 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?
Gadoxetate disodium is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for motor function.
Also referred to as Eovist, Primovist.
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
- 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.
- 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...
- Participants should have at least 1 of the following indications: a) Medium to high risk for breast cancer or dense breasts undergoing breast cancer...
- Each participant should be likely to undergo ≥5 GBCA-enhanced MR examinations with the same GBCA at least annually throughout the 5-year study...
- Prospective participants with up to 3 well documented GBCA administrations prior to study screening are acceptable, provided that the imaging was...
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)
- Participants should have at least 1 of the following indications: a) Medium to high risk for breast cancer or dense breasts undergoing breast cancer screening with MRI, b) Elevated prostate-specific antigen (PSA) and...
- 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...
- 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. In Years 1 to 4, the control participants will undergo their clinically indicated UE-MRIs, computed tomography (CT)...
- 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
- Presence of any metal-containing joint implants/prostheses In addition, for participants in either of the GBCA Arms only: \- Receipt of a GBCA or generic prior to study entry other than the specific GBCA to be...
- 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's taking place
- Scottsdale, Arizona, United States
- New Haven, Connecticut, United States
- Chicago, Illinois, United States
- Peoria, Illinois, United States
- Boston, Massachusetts, United States
- Methuen, Massachusetts, United States
- Worcester, Massachusetts, United States
- St Louis, Missouri, United States
- Chapel Hill, North Carolina, United States
- Hershey, Pennsylvania, United States
- Philadelphia, Pennsylvania, United States
- Dallas, Texas, United States
- Houston, Texas, United States
- Madison, Wisconsin, United States
- Taguatinga, Federal District, Brazil
- Natal, Rio Grande do Norte, Brazil
- Passo Fundo, Rio Grande do Sul, Brazil
- Porto Alegre, Rio Grande do Sul, Brazil
- Florianópolis, Santa Catarina, Brazil
- São Bernardo do Campo, São Paulo, Brazil
+ 24 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 - 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?
Study sites include Scottsdale, Arizona, United States; New Haven, Connecticut, United States; Chicago, Illinois, United States; Peoria, Illinois, United States; Boston, Massachusetts, United States; Methuen, Massachusetts, United States and 38 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.