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Study on the Long-Term Effects of Gadoxetic Acid, Gadoteridol, and Gadobenate Dimeglumine on Motor and Cognitive Functions in Healthy Adults

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on understanding the long-term effects of repeated use of gadolinium-based contrast agents (GBCAs) on motor and cognitive functions in adults who are neurologically normal, meaning they do not have any unstable neurological or psychiatric conditions. GBCAs are substances used in Magnetic Resonance Imaging (MRI) to enhance the clarity of the images. The study will compare individuals who have been exposed to GBCAs with those who have not, to see if there are any changes in their motor skills and cognitive abilities over a period of five years.

The study involves several types of GBCAs, including Gadoxetic Acid, Disodium, Gadoteridol, Gadobenate Dimeglumine, Gadoteric Acid, and Gadobutrol. Participants in the study will receive these agents through an intravenous injection, which means the substance is delivered directly into a vein. The purpose of the study is to assess whether repeated exposure to these agents affects the participants' motor and cognitive functions over time. Participants will undergo regular MRI scans and other assessments to monitor any changes in their health.

Throughout the study, participants will be monitored for any adverse effects, which are any unwanted or harmful effects that may occur after taking a medication or undergoing a procedure. Blood and urine samples will be collected to measure the levels of gadolinium in the body. The study aims to provide valuable insights into the safety and long-term effects of using GBCAs in medical imaging, helping to ensure that these agents are used safely in the future.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Enrollment and initial assessment
Upon joining the study, you will undergo an initial assessment to confirm eligibility. This includes a neurological examination to ensure you are free of unstable neurological and psychiatric conditions.
You will also have an unenhanced magnetic resonance imaging (UE-MRI) of the brain to establish a baseline for future comparisons.
Step 2
Annual visits and imaging
Each year, for five years, you will attend an annual visit. During these visits, your motor and cognitive functions will be assessed through various tests.
If you are in the GBCA group, you will receive a gadolinium-based contrast agent injection intravenously for enhanced MRI scans. The specific agent used will be consistent throughout the study.
Step 3
Monitoring and sample collection
At each annual visit, blood and urine samples will be collected to measure total gadolinium concentrations. These samples will be taken before any MRI imaging if it occurs on the same day.
Any side effects or adverse events will be recorded, including their onset, severity, and any treatment required.
Step 4
Final assessment
At the end of the five-year period, a final assessment will be conducted. This includes another UE-MRI of the brain to compare with the initial baseline scan.
The results from all tests and assessments will be used to evaluate any changes in motor and cognitive functions over the study period.

Who can join the trial?

14 criteria

Participant must be an adult who is at least the legal age of majority and less than 65 years old.
Participant must be neurologically normal, meaning they do not have any unstable brain or mental health conditions, confirmed by a normal brain health check at the start.
Participant agrees to be part of the study for 5 years and follow the testing schedule.
Participant agrees to have a magnetic resonance imaging (MRI) scan of the brain without contrast at the start and end of the 5-year study period.
Participant must have national health insurance, if required by local rules.
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Participant should have at least one of the following health conditions:
- Medium to high risk for breast cancer or dense breasts, needing breast cancer screening with MRI.
- High prostate-specific antigen (PSA) levels, under active monitoring for prostate cancer.
- Chronic liver disease, such as mild liver cirrhosis or chronic liver inflammation, for liver cancer monitoring.
- Low-grade colorectal cancer or neuroendocrine tumor, under monitoring for liver spread.
- Small pancreatic growths, under imaging monitoring.
- For participants in the GBCA Arms only: Participant should expect to have at least 5 MRI scans with the same gadolinium-based contrast agent (GBCA) each year during the 5-year study.
- For participants in the GBCA Arms only: Participant can have had up to 3 previous MRI scans with the same GBCA before joining the study, but if the GBCA used before is unknown, they cannot join.
- For the Control Arm: Participant must be willing to have an MRI scan of the brain without contrast at the start and end of the study, and other necessary scans during the study.
- For the Control Arm: Participant must not have had or expect to have any GBCA injections during the study.

Who cannot join the trial?

9 criteria

Patients who have had previous exposure to a gadolinium-based contrast agent (GBCA) cannot participate. GBCAs are substances used in medical imaging to improve the clarity of the images.
Patients with any known allergies to gadolinium or any components of the contrast agent are excluded.
Individuals with a history of severe kidney problems, as these can affect how the body handles the contrast agent, are not eligible.
Patients with any neurological disorders, which are conditions affecting the brain, spinal cord, or nerves, cannot take part in the study.
Pregnant or breastfeeding women are not allowed to participate, as the effects on the baby are not known.
Individuals who are unable to undergo MRI scans, which are imaging tests that use strong magnets and radio waves to create pictures of the inside of the body, are excluded.
Patients who are participating in another clinical trial at the same time are not eligible.
Anyone with a history of severe allergic reactions to any medications or substances is excluded.
Individuals with any other medical condition that the study doctors believe would make participation unsafe or affect the study results cannot participate.

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Verified sites

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Responsive
Azienda Ospedaliera Universitaria Senese
Siena, Italy
Responsive
Istituto Europeo Di Oncologia S.r.l.
Milan, Italy
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Universita' Degli Studi Di Verona
Verona, Italy

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Investigated drugs

Gadolinium-based contrast agent (GBCA) is a special type of dye used in medical imaging, like MRI scans, to help doctors see the inside of your body more clearly. In this study, researchers are looking at how repeated use of this dye might affect movement and thinking skills over time in people who are otherwise healthy. They are comparing these effects to people who have not been exposed to the dye.

What is already known about the treatment

Gadolinium-based contrast agent (GBCA) – Gadolinium-based contrast agents are substances used in medical imaging, particularly in MRI scans, to enhance the clarity of the images. They are administered intravenously, meaning they are injected into a vein. Currently, these agents are widely used in clinical practice and are well-documented in medical literature. The main therapeutic indication for GBCAs is to improve the visibility of internal structures in MRI scans, aiding in the diagnosis of various conditions. At the molecular level, GBCAs work by altering the magnetic properties of nearby water molecules, which enhances the contrast of the images produced. They are classified pharmacologically as contrast media.

Investigated diseases

Long-term potential effect of repeated exposure to gadolinium-based contrast agents – This condition involves the study of potential changes in motor and cognitive functions due to repeated exposure to gadolinium-based contrast agents (GBCAs) in neurologically normal adults. GBCAs are used in magnetic resonance imaging (MRI) to enhance the clarity of the images. The study focuses on the long-term effects over a period of five years, comparing individuals exposed to GBCAs with those who are not. The progression of this condition is monitored through changes in motor and cognitive functions, assessed by a composite z score. The study aims to understand if repeated exposure to GBCAs can lead to measurable changes in these functions over time.