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Gadolinium-Based Contrast Media Effects on Motor and Cognitive Functioning (ODYSSEY Trial)
ODYSSEY Trial Summary
This trial is looking at the effects of contrast media on human organs and tissue during x-ray, CT-scan, or MRI investigations.
ODYSSEY Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowODYSSEY Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.ODYSSEY Trial Design
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Who is running the clinical trial?
Media Library
- I am participating in a trial that involves Gadolinium-Based Contrast Agents.I am participating in the GBCA Arms of the study.My kidney function is reduced with an eGFR below 60.I need more than one MRI with contrast every 6 months.You have metal implants or artificial joints in your body.You have one of the following conditions and are undergoing screening or surveillance to detect potential cancer:
- Medium to high risk for breast cancer or dense breasts undergoing breast cancer screening with MRI
- Elevated PSA and under active diagnostic surveillance for prostate cancer
- Chronic liver disease for surveillance of hepatocellular carcinoma development
- Low-grade colorectal cancer or neuroendocrine tumor undergoing screening for liver metastases
- Branch-duct intraductal papillary mucinous neoplasm (IPMN) of the pancreas (maximum size ≤2 cm) undergoing imaging surveillance.You have been exposed to certain chemicals in your environment or job that can potentially affect your memory, thinking skills, or physical abilities. These chemicals include things like heavy metals, pesticides, solvents, or carbon monoxide.I have been exposed to a gadolinium-based contrast agent before.I have not received any contrast agents for MRI other than the one planned for this study.I agree to have specific brain scans now and in 5 years, with other scans as needed in between.I am taking medication that affects my thinking or movement.I do not have any neurological or psychiatric conditions that could affect study results.I am expected to have 5 or more MRI scans with contrast each year for 5 years.I have liver damage due to heavy drinking.I agree to have two brain MRIs: one now and another in 5 years.I have had up to 3 MRI contrasts with the same agent that will be used in the study.I have never had and don't plan to have a GBCA injection.You have a history of drug or alcohol abuse, as determined by the doctor in charge of the study.I am currently undergoing, or have plans for, chemotherapy or brain radiation.
- Group 1: No GBCA (Control arm)
- Group 2: Linear GBCAs
- Group 3: Macrocyclic GBCAs
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Has research been conducted on Motor Tests previously?
"Currently, there are 10 trials actively studying Motor Tests with none of them in their final stage. Most sites for this type of research can be found in the city of Houston; nevertheless, 43 medical centres across the country are running clinical trials related to it."
Is this experiment still open for enrollment?
"Affirmative. Clinicaltrials.gov maintains the public record that this study, initially posted in March of 2021, is actively enlisting participants. Over two thousand people are needed across 12 different sites to complete this trial."
Do applicants need to meet a certain age requirement for participating in this experiment?
"The age range required to be considered eligible for this medical study is between 18 and 64."
What is the total participant count of this trial?
"Affirmative. Information accessible on clinicaltrials.gov attests that this medical trial, which was first announced on March 24th 2021, is actively recruiting participants. Approximately 2076 patients must be enrolled from 12 different healthcare facilities."
Is it possible to join this medical research initiative?
"This medical trial is accepting 2076 patients between the age of majority and 64 years old who have contrast medium. These participants will additionally need to display neurological normalcy, with a passing neurologic examination at screening, as well as no prior or expected exposure to GBCA injections over the course of this study."
Has the FDA sanctioned Motor Tests for public use?
"There is extensive scientific data backing the safety of Motor Tests, thus it was awarded a 3 under our team's rating system. This product has been approved for clinical use as part of Phase 4 trials."
What medical purposes does Motor Tests typically serve?
"Motor Tests is typically given to those suffering from veno-occlusive disease but can also provide relief for other aliments like chronic liver diseases, stenosis and neurological disorders."
What is the geographical scope of this research trial?
"This trial is currently conducted in 12 distinct medical centres, including ones located in New Haven, Peoria and Boston. Therefore, it is wise to choose the closest location for enrollment so as to minimize travel requirements."
Who else is applying?
What state do they live in?
What portion of applicants met pre-screening criteria?
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