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Long-term impact of GBCAs on motor and cognitive function following repeated Contrast-Enhanced MRI—ODYSSEY
EU CTIS ID: 2024-515462-14-00
What this study is testing
To prospectively assess the potential effect of repeated exposure to either a linear or a macrocyclic gadolinium-based contrast agent (GBCA) on change from baseline to Year 5 in motor and cognitive function among neurologically normal adults in comparison to a matched non-GBCA–exposed control group.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Participant must be an adult having reached legal majority age and less than 65 years old.
- For the Control Arm: 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), ultrasound, or X-ray procedures.
- For the Control Arm: Participants matched with the population characteristics of the 2 GBCA study arms, including clinical indication for imaging, geographic region, and age-group. Additional potential risk factors (education level and sex) will be recorded and adjusted for as appropriate at the statistical analysis stage.
- Participant must be neurologically normal, defined as free of unstable neurologic and psychiatric disease as confirmed by a normal neurologic examination at screening.
- Participant agrees to be tested as per protocol for 5 consecutive years.
- 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).
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 could influence the results of the study’s motor and cognitive tests. Examples include but are not limited to: • 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 (NOS)—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 (e.g., trisomy 21) • Uncontrolled severe migraine • Uncontrolled or controlled anxiety or depression within 6 months before enrollment • Screening scores of ≤24 on the Mini-Mental State Examination (MMSE) and/or ≥11 on the Hospital Anxiety and Depression Scale (HADS)
- Clinical indications requiring >1 contrast-enhanced magnetic resonance imaging (CE-MRI) every 6 months.
- Receipt of any investigational product or participation in any other clinical trial within 30 days prior to enrolling in this study or while enrolled in this trial.
- Previous enrollment in this study.
- Pregnant or nursing (lactating) women.
- Presence of any metal-containing joint implants/prostheses.
See the full eligibility criteria
Who can join
- Participant must be an adult having reached legal majority age and less than 65 years old.
- For the Control Arm: 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), ultrasound, or X-ray procedures.
- For the Control Arm: Participants matched with the population characteristics of the 2 GBCA study arms, including clinical indication for imaging, geographic region, and age-group. Additional potential risk factors (education level and sex) will be recorded and adjusted for as appropriate at the statistical analysis stage.
- Participant must be neurologically normal, defined as free of unstable neurologic and psychiatric disease as confirmed by a normal neurologic examination at screening.
- Participant agrees to be tested as per protocol for 5 consecutive years.
- 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).
- Patient affiliated to national health insurance according to local regulatory requirements, where applicable.
- Participants should have at least 1 of the following indications: • Medium to high risk for breast cancer or with dense breasts undergoing breast cancer screening with magnetic resonance imaging (MRI) • Elevated prostate-specific antigen (PSA) and under active diagnostic surveillance for prostate cancer • Chronic liver disease (e.g., liver cirrhosis limited to Child class A, post-hepatitis chronic hepatopathy, or primary sclerosing cholangitis) for surveillance of hepatocellular carcinoma (HCC) development • Low-grade colorectal cancer or neuroendocrine tumor undergoing surveillance for liver metastases • Branch-duct intraductal papillary mucinous neoplasm (IPMN) of the pancreas (maximum size ≤2 cm) undergoing imaging surveillance
- In addition, for participants in the GBCA Arms 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.
- In addition, for participants in the GBCA Arms only : 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.
What rules you out
- 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. Examples include but are not limited to: • 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 (NOS)—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 (e.g., trisomy 21) • Uncontrolled severe migraine • Uncontrolled or controlled anxiety or depression within 6 months before enrollment • Screening scores of ≤24 on the Mini-Mental State Examination (MMSE) and/or ≥11 on the Hospital Anxiety and Depression Scale (HADS)
- Clinical indications requiring >1 contrast-enhanced magnetic resonance imaging (CE-MRI) every 6 months.
- Receipt of any investigational product or participation in any other clinical trial within 30 days prior to enrolling in this study or while enrolled in this trial.
- Previous enrollment in this study.
- Pregnant or nursing (lactating) women.
- Presence of any metal-containing joint implants/prostheses.
- In addition, for participants in either of the GBCA Arms only: Any contraindication to GBCA-enhanced MRI examinations.
- 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 administered during the course of the study.
- In addition, for participants in the Control Arm only: Participants with any previous exposure to a GBCA.
- In addition, for participants in the Control Arm only: Participants with any contraindication to UE-MRI examinations.
- Prior, planned, or ongoing chemotherapy or brain irradiation.
- Use of concomitant medication (CM)(s) affecting neuro-cognitive or motor function (an authorized exception is a single intake before the study MRI because of anxiety if administered after the motor and cognitive test evaluation): • Regular use of benzodiazepines or non-benzodiazepine hypnotics. Long-acting benzodiazepines (e.g., diazepam) should not be administered within 24 hours prior to cognitive testing. • Short/medium-acting benzodiazepines (e.g., alprazolam, lorazepam, oxazepam, temazepam), except if used chronically for sleep and on a stable dose for 8 weeks prior to Screening Visit 1 or 12 hours prior to cognitive testing • Regular use of anticholinergic drugs (anticholinergics for bladder control with limited cognitive effects are permitted) • Long-term use of corticosteroids or methotrexate, cladribine • Regular use of antidepressants (e.g., anticholinergic, tricyclic, monoamine oxidase inhibitors (MAOIs), norepinephrine–dopamine reuptake inhibitors (NDRIs) selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), or lithium, antiepileptics and/or antipsychotic drugs: Use of antidepressants is allowed if at stable doses for 8 weeks prior to Screening Visit. Antipsychotics used on a regular basis, except for low doses of atypical antipsychotics (e.g., risperidone, aripiprazole, or quetiapine), anticonvulsants with limited cognitive effects, such as lamotrigine, pregabalin, levetiracetam for treatment of pain, and other non-epilepsy indications, are allowed as-needed basis or if used at a stable dose for 8 weeks prior to Screening Visit • CNS stimulants (e.g., for attention-deficit/hyperactivity disorder [ADHD])
- Substance or alcohol abuse as determined by the investigator.
- Alcoholic cirrhosis.
- Any history or presence of other relevant chronic disease that prevents participation in the study or that may confound neurofunction testing.
- Renal disease, defined as estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2, calculated by using the Modification of Diet in Renal Disease (MDRD) formula or the Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.
- 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.
- Anticipated, current, or past conditions (medical, psychological, social, or geographical) that, in the opinion of the investigator, would compromise the participant’s safety or her/his ability to participate in the study (e.g., clinically significant vitamin B12 deficiency, folic acid deficiency, uncontrolled thyroid dysfunction from medical history).
The study team makes the final eligibility decision.
Where it's taking place
- Russian Federation
- Korea, Republic of
- Brazil
- United States
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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Russian Federation; Korea, Republic of; Brazil; United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.