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Gadolinium-Based Contrast Media Effects on Motor and Cognitive Functioning (ODYSSEY Trial)

Phase 4
Recruiting
Research Sponsored by Guerbet
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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 under active diagnostic surveillance for prostate cancer, c) Chronic liver disease (eg, liver cirrhosis limited to Child class A, post-hepatitis chronic hepatopathy, or primary sclerosing cholangitis) for surveillance of hepatocellular carcinoma development, d) Low-grade colorectal cancer or neuroendocrine tumor undergoing screening for liver metastases or e) 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:
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline, years 1, 2, 3, 4, 5
Awards & highlights

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.

Who is the study for?
Adults up to 65 years old needing regular MRI scans for conditions like medium/high-risk breast cancer, prostate cancer surveillance, or chronic liver disease. Participants must be neurologically stable with no severe kidney issues, not pregnant/nursing, and free from heavy metal exposure that could affect brain function.Check my eligibility
What is being tested?
The study is examining if repeated use of gadolinium-based contrast agents (GBCAs) during MRIs over five years affects motor skills and cognitive functions. It involves annual MRIs and tests on body movement/mental skills across four GBCA types versus unenhanced-MRI controls.See study design
What are the potential side effects?
While the trial primarily monitors long-term effects on motor/cognitive functions rather than immediate side effects, potential risks may include allergic reactions to GBCAs or nephrogenic systemic fibrosis in those with pre-existing kidney problems.

ODYSSEY Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am participating in the GBCA Arms of the study.
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I agree to have specific brain scans now and in 5 years, with other scans as needed in between.
Select...
I am expected to have 5 or more MRI scans with contrast each year for 5 years.
Select...
I agree to have two brain MRIs: one now and another in 5 years.
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I have had up to 3 MRI contrasts with the same agent that will be used in the study.
Select...
I have never had and don't plan to have a GBCA injection.

ODYSSEY Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at baseline, years 1, 2, 3, 4, 5
This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline, years 1, 2, 3, 4, 5 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in cognitive function from baseline to year 5 in comparison to a matched non-GBCA-exposed control group
Change of motor function from baseline to year 5 in comparison to a matched non-GBCA-exposed control group
Secondary outcome measures
Change from baseline for each of the individual tests (motor and cognitive) at each of the post-baseline time points (Years 1 to 5) in GBCA-exposed participants as compared to controls.
Change from baseline in the composite endpoints (motor and cognitive) at each of the post-baseline time points (Years 1 to 4) in GBCA-exposed participants as compared to controls.
Number of participants with adverse events
+1 more

ODYSSEY Trial Design

3Treatment groups
Experimental Treatment
Group I: No GBCA (Control arm)Experimental Treatment4 Interventions
Adult participants who were never exposed to any gadolinium-based contrast agent and matching the population characteristics of the two GBCA arms. They will not receive any gadolinium-based contrast agent over the study course, but may undergo clinically indicated imaging (e.g. unenhanced magnetic resonance imaging (MRI), unenhanced or enhanced computed tomography, ultrasound and/or X-ray).
Group II: Macrocyclic GBCAsExperimental Treatment7 Interventions
Adult participants, who were scheduled for repeated enhanced magnetic resonance imaging (MRI), receive a macrocyclic gadolinium-based contrast agent (GBCA, i.e. Gadavist/ Gadovist, Dotarem, Magnescope or ProHance) prior to MRI. Each participant will receive the same GBCA throughout the study.
Group III: Linear GBCAsExperimental Treatment7 Interventions
Adult participants, who were scheduled for repeated enhanced magnetic resonance imaging (MRI), receive a linear gadoliniumbased contrast agent (GBCA, i.e. Eovist/ Primovist, MultiHance or Omniscan) prior to MRI. Each participant will receive the same GBCA throughout the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gadobenate dimeglumine
2019
Completed Phase 2
~360
Gadobutrol
2020
Completed Phase 3
~250
Cognitive Tests
2013
Completed Phase 2
~110
Gadoteridol
2015
Completed Early Phase 1
~40

Find a Location

Who is running the clinical trial?

GuerbetLead Sponsor
68 Previous Clinical Trials
91,646 Total Patients Enrolled
Bayer AG (Sponsor)UNKNOWN
Bracco (Sponsor)UNKNOWN

Media Library

Motor Tests Clinical Trial Eligibility Overview. Trial Name: NCT04373564 — Phase 4
Contrast Media Research Study Groups: No GBCA (Control arm), Linear GBCAs, Macrocyclic GBCAs
Contrast Media Clinical Trial 2023: Motor Tests Highlights & Side Effects. Trial Name: NCT04373564 — Phase 4
Motor Tests 2023 Treatment Timeline for Medical Study. Trial Name: NCT04373564 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Who else is applying?

What state do they live in?
District of Columbia
Massachusetts
What portion of applicants met pre-screening criteria?
Did not meet criteria
~1272 spots leftby Dec 2028