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Gadoxetic Acid, Disodium

The ODYSSEY study is a comprehensive clinical trial investigating the long-term impact of repeated exposure to gadolinium-based contrast agents (GBCAs), specifically Gadoxetic Acid, Disodium, on motor and cognitive functions in neurologically normal adults. This 5-year study aims to assess the safety and potential effects of GBCAs used in contrast-enhanced MRI examinations, comparing GBCA-exposed participants to a non-exposed control group.

Table of Contents

What is Gadoxetic Acid, Disodium?

Gadoxetic acid, disodium is a type of gadolinium-based contrast agent (GBCA) used in medical imaging, specifically in Magnetic Resonance Imaging (MRI) scans[1]. GBCAs are substances that help improve the visibility of internal body structures during an MRI examination. Gadoxetic acid is also known by other names, including its brand names, which may vary depending on the manufacturer.

Medical Uses

Gadoxetic acid, disodium is primarily used to enhance the quality of MRI scans for various medical conditions. Some of the key uses include:

  • Liver imaging: It’s particularly useful for patients with chronic liver diseases, such as cirrhosis, to detect and monitor hepatocellular carcinoma (HCC), a type of liver cancer[1].
  • Cancer detection and monitoring: It’s used in screening for breast cancer, especially in patients with dense breast tissue[1].
  • Prostate cancer diagnosis: For patients with elevated prostate-specific antigen (PSA) levels who are under surveillance for prostate cancer[1].
  • Colorectal cancer surveillance: To monitor for liver metastases in patients with low-grade colorectal cancer[1].
  • Pancreatic imaging: For surveillance of certain pancreatic conditions, such as intraductal papillary mucinous neoplasm (IPMN)[1].

How is it Administered?

Gadoxetic acid, disodium is administered as an intravenous injection. The typical dose is 0.1 milliliters per kilogram of body weight[1]. It’s usually given just before or during the MRI scan, depending on the specific imaging protocol being used.

Safety Concerns and Long-Term Effects

While gadoxetic acid and other GBCAs are generally considered safe, there are some concerns about their long-term effects, particularly with repeated use. Some key points to consider:

  • Gadolinium retention: There’s evidence that small amounts of gadolinium can be retained in the body, including in the brain, after multiple GBCA administrations[1].
  • Renal function: Patients with impaired kidney function (with an estimated glomerular filtration rate less than 60 mL/min/1.73 m²) may be at higher risk for complications and are typically excluded from receiving GBCAs[1].
  • Pregnancy and breastfeeding: GBCAs are generally avoided in pregnant or nursing women due to potential risks to the fetus or infant[1].

Ongoing Research: The ODYSSEY Study

To better understand the long-term effects of repeated GBCA use, including gadoxetic acid, a large-scale study called ODYSSEY is currently underway. This study aims to:

  • Evaluate the potential effects of repeated GBCA administrations on motor and cognitive functions in neurologically normal adults[1].
  • Compare GBCA-exposed individuals to a control group not exposed to GBCAs over a 5-year period[1].
  • Assess changes in motor and cognitive function through various tests and examinations[1].
  • Monitor gadolinium concentrations in blood and urine samples of participants[1].

Patient Considerations

If you’re scheduled to receive gadoxetic acid or any other GBCA for an MRI, here are some important points to discuss with your healthcare provider:

  • Inform your doctor about any allergies, especially to contrast agents or metals.
  • Discuss your complete medical history, including any kidney problems or previous reactions to contrast agents.
  • If you’re pregnant or breastfeeding, make sure to inform your healthcare team.
  • Ask about the necessity of the contrast agent for your specific examination and if there are any alternatives.
  • If you’re participating in the ODYSSEY study or any similar research, ensure you understand the commitments and potential risks involved.

Remember, while there are some concerns about the long-term effects of GBCAs, they remain an important tool in medical imaging, often providing crucial information for diagnosis and treatment planning. The benefits of using these agents typically outweigh the potential risks for most patients, but it’s always important to have an open discussion with your healthcare provider about your specific situation.

Aspect Details
Study Name ODYSSEY (Long-term impact of GBCAs on motor and cognitive function following repeated Contrast-Enhanced MRI)
Primary Objective To assess the potential effect of repeated exposure to GBCAs on motor and cognitive function over 5 years
Study Population Neurologically normal adults aged 18-65 years
Contrast Agent Gadoxetic Acid, Disodium (and other GBCAs)
Study Duration 5 years
Key Assessments Motor function tests, cognitive function tests, blood and urine gadolinium levels, brain MRI scans
Safety Monitoring Adverse event recording and evaluation

FAQ

  • What is the purpose of the ODYSSEY study? The ODYSSEY study aims to evaluate the potential long-term effects of repeated exposure to gadolinium-based contrast agents (GBCAs), including Gadoxetic Acid, Disodium, on motor and cognitive functions in neurologically normal adults over a 5-year period.
  • Who can participate in the ODYSSEY study? Participants must be adults under 65 years old, neurologically normal, and have specific medical indications such as breast cancer screening, prostate cancer surveillance, or chronic liver disease. They should be willing to undergo at least 5 GBCA-enhanced MRI examinations over the study period.
  • What tests will be performed during the study? Participants will undergo motor and cognitive function tests annually for 5 years. Additionally, blood and urine samples will be collected to measure gadolinium concentrations, and unenhanced brain MRI scans will be performed at the beginning and end of the study.
  • Are there any risks associated with participating in the study? The study involves repeated exposure to GBCAs, which is being investigated for potential long-term effects. Participants will be monitored closely, and adverse events will be recorded throughout the study. The study aims to better understand the safety profile of these contrast agents.
  • How will the results of the ODYSSEY study be used? The results of this study will provide valuable information about the long-term safety of GBCAs, including Gadoxetic Acid, Disodium. This information will help healthcare providers and patients make more informed decisions about the use of contrast agents in MRI examinations.

Ongoing Clinical Trials on Gadoxetic Acid, Disodium

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

    Not yet recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    France Germany Italy

Glossary

  • Gadolinium-based contrast agent (GBCA): A type of contrast medium used in magnetic resonance imaging (MRI) to enhance the visibility of internal body structures. Gadoxetic Acid, Disodium is a specific type of GBCA used in this study.
  • Contrast-Enhanced MRI (CE-MRI): A type of MRI scan that uses a contrast agent, such as a GBCA, to improve the visibility of certain tissues or blood vessels in the body.
  • Unenhanced MRI (UE-MRI): An MRI scan performed without the use of a contrast agent.
  • Motor function: The ability to move and control body movements, which is one of the main aspects being evaluated in this study.
  • Cognitive function: Mental processes involved in gaining knowledge and comprehension, including thinking, knowing, remembering, judging, and problem-solving. This is another key aspect being assessed in the ODYSSEY study.
  • Neurologically normal: Having no significant neurological disorders or conditions that could affect brain function or the study results.
  • Glomerular filtration rate (eGFR): A measure of how well the kidneys are filtering waste from the blood. This is important in the study as participants must have an eGFR of 60 mL/min/1.73 m2 or higher.
  • Composite z score: A statistical measure used in the study to combine and analyze the results of multiple motor and cognitive function tests.
  • Adverse event (AE): Any unfavorable and unintended sign, symptom, or disease that occurs during the study, whether or not it is related to the study procedures or medications.

References

  1. http://clinicaltrials.eu/trial/study-on-the-long-term-effects-of-gadoxetic-acid-gadoteridol-and-gadobenate-dimeglumine-on-motor-and-cognitive-functions-in-healthy-adults/