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Motor FunctionPhase 4ODYSSEYNCT04373564

Effect on Body Movement and Mental Skills in Patients Who Received Gadolinium-based Contrast Media for Magnetic Resonance Examination Multiple Times Within 5 Years

A Phase 4 study testing Motor Tests, Cognitive Tests and Unenhanced-MRI of the brain in people with Motor Function and Cognitive Function, run by Guerbet at 51 sites in 8 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This study is a postmarketing requirement jointly carried out by four NDA holders (Bayer AG, Bracco, GE Healthcare and Guerbet) and the CRO IQVIA. The study aims to create detailed images of the organs and tissue of the human body during x-ray, CT-scan or MRI investigations, doctors are using contrast media (a kind of… Read more about this study

Who is it for?
Ages 18 to 64 years
Conditions the study is for
Motor Function, Cognitive Function, Contrast Media
What is being tested?
Motor Tests, Cognitive Tests and Unenhanced-MRI of the brain
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,076 participants
Where
51 sitesin 8 countries
Study dates
24 Mar 2021to 31 Dec 2028
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 64 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Participant must be neurologically normal, defined as free of unstable neurologic and psychiatric disease as confirmed by a normal neurologic examination at screening
  • 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)
  • 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:
  • 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
  • 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.
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  • For the Control Arm:
  • Participants who never had and are not likely to receive any GBCA injection during the course of the study
  • 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

Who cannot join

  • 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 (e.g. 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 - 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 (eg, trisomy 21), Uncontrolled severe migraine, Uncontrolled or controlled anxiety or depression within 6 months before enrollment, Screening scores of ≤24 on the MMSE and/or ≥11 on the Hospital Anxiety and Depression Scale (HADS)).
  • Prior, planned, or ongoing chemotherapy or brain irradiation
  • Use of concomitant medication(s) affecting neuro-cognitive or motor function
  • Substance or alcohol abuse as determined by the investigator
  • Alcoholic cirrhosis
  • Renal disease, defined as estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m2
Show all 15Show fewer
  • 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.
  • Clinical indications requiring >1 contrast enhanced magnetic resonance imaging (CE-MRI) every 6 months
  • Pregnant or nursing (lactating) women
  • Presence of any metal-containing joint implants/prostheses
  • 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.
  • For participants in the Control Arm only:
  • Participants with any previous exposure to a GBCA.
  • Participants with any contraindication to UE-MRI examinations.

Trial locations and contacts

51 sites in 8 countries. Contact the study team or a site near you to ask about taking part.

Nathalie LE FUR, PhD contact

+33649351166

nathalie.lefur@guerbet.com

Frantz HEBERT contact

+33680249334

frantz.hebert@guerbet.com

51 sites in 8 countries

United States16 sites, 8 recruiting

  • Massachussets General Hospital

    Boston, Massachusetts, 02114

    617-726-8396

    Mukesh Harisinghani, MD

    Recruiting

  • Boston University Medical Center

    Boston, Massachusetts, 02118

    Terminated

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

    Withdrawn

  • UNC School of Medicine

    Chapel Hill, North Carolina, 27599

    Withdrawn

  • University of Chicago Medical Center

    Chicago, Illinois, 60637

    Valentine Mildred, 7737029812, mvalenti@neurology.bsd.uchicago.edu

    Adil Javed, MD

    Recruiting

  • UT Southwestern Medical Center

    Dallas, Texas, 75390

    Sydney Haldeman Sydney, sydney.haldeman@utsouthwestern.edu

    Takeshi Yokoo, MD

    Recruiting

  • Penn State Hershey Medical Center

    Hershey, Pennsylvania, 17033

    Rebecca Jordan, rjordan@pennstatehealth.psu.edu

    Nabeel SARWANI, MD

    Recruiting

  • MD Anderson Cancer Center

    Houston, Texas, 77030

    Withdrawn

  • University of Wisconsin

    Madison, Wisconsin, 53792

    Nolan Caroll, ncarroll@clinicaltrials.wisc.edu

    Bruce Richard, MD

    Recruiting

  • ActivMed Practices & Research, Inc.

    Methuen, Massachusetts, 01844

    Withdrawn

  • Yale University School of Medicine

    New Haven, Connecticut, 06520

    Withdrawn

  • Methodist Medical Center of Illinois

    Peoria, Illinois, 61637

    Teresa Osmulski, 3096724808, teresa.osmulski@unitypoint.org

    Praveen Sudhindra, MD

    Recruiting

  • Albert Einstein Healthcare Network

    Philadelphia, Pennsylvania, 19141

    Meera Kasireddy, 2154566370, kasiredm@einstein.edu

    Ryan Lee, MD

    Recruiting

  • Scottsdale Medical Imaging, LLC

    Scottsdale, Arizona, 85260

    4804254194, comrkorn@imagingendpoints.com

    Ronald Korn, MD

    Recruiting

  • Department of Radiology

    St Louis, Missouri, 63110

    Withdrawn

  • University of Massachusetts Memorial Medical Center

    Worcester, Massachusetts, 01655

    Terminated

Other trials in United States

Brazil10 sites, 4 recruiting

  • Instituto Baía Sul de Ensino e Pesquisa (IEP)

    Florianópolis, Santa Catarina, 88020-210

    Withdrawn

  • Liga Norte-Rio-Grandense Contra o Câncer

    Natal, Rio Grande do Norte, 59075-740

    Withdrawn

  • Instituto Mederi de Pesquisa e Saude

    Passo Fundo, Rio Grande do Sul, 99010-120

    Keyla Deucher, +5549991379921, keyla.deucher@bioservsmo.com.br

    Cassiano Mateus Forcelini, MD

    Recruiting

  • Hospital Moinhos de Vento

    Porto Alegre, Rio Grande do Sul, 90035-001

    Brenda Santos, +555133203479, brenda.santos@hmv.org.br

    Arthur Pille, MD

    Recruiting

  • CEMEC - Oncológica

    São Bernardo do Campo, São Paulo, 09715-090

    Withdrawn

  • CEMEC - Oncológica

    São Bernardo do Campo

    Withdrawn

  • Fundação Faculdade Regional de Medicina de São José do Rio Preto

    São José do Rio Preto, São Paulo, 15090-000

    Luciana Cubas Volpe, +551732015054, lucianacubas@gmail.com

    Kathia Abdalla

    Recruiting

  • CPCLIN - Centro de Pesquisas Clínicas Ltda.

    São Paulo, São Paulo, 01228-200

    Terminated

  • Albert Einstein Sociedade Beneficente Israelita Brasileira

    São Paulo, São Paulo, 05652000

    Gilberto Szarf, gilberto.szarf@einstein.br

    Ronaldo Baroni, MD

    Recruiting

  • Hospital Santa Marta

    Taguatinga, Federal District, 72025-110

    Terminated

Other trials in Brazil

South Korea8 sites, 6 recruiting

  • Inje University Busan Paik Hospital

    Busan, 47392

    Hayun Jung, +82518908975, ejjung@busanpaik.ac.kr

    Hae Woong Jeong, MD

    Recruiting

  • Pusan National University Hospital

    Busan, 49241

    Yun Jung, yunj555@naver.com

    Jeong Heo, MD

    Recruiting

  • Hallym University Chuncheon Sacred Heart Hospital

    Chuncheon, Gangwon-do, 24253

    Withdrawn

  • Chonnam National University Hospital

    Gwangju, Gyeonggi-do, 61469

    Withdrawn

  • Chosun University Hospital

    Gwangju, 61453

    Gyu Won Kim, nakgp2191@naver.com

    Lee Jun-Hyung, MD

    Recruiting

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620

    JinSil Choi, rkwkqwe@gmail.com

    Won Chang, MD

    Recruiting

  • Gangnam Severance Hospital, Yonsei University Health System

    Seoul, 06273

    so hyun Kim, "+82220194608 -0-0000-0000", sohyunzang@gmail.com

    Joon Jeong, MD

    Recruiting

  • Chung-Ang University Hospital

    Seoul, 06973

    DaJeong Kwon, +821029011336, d5301@caumc.or.kr

    Chang-hwan Choi, MD

    Recruiting

Other trials in South Korea

Russia7 sites

  • BHI of Omsk region "Clinical Oncology Dispensary"

    Omsk, 644013

    Suspended

  • FSBI "National medical scientific center of psychiatry and neurology n.a. V.M. Bekhterev" Adolescent

    Saint Petersburg, 192019

    Suspended

  • FSBI North-West Federal Medical Research Center n.a. V.A. Almazov of MoH RF

    Saint Petersburg, 197341

    Suspended

  • LLC Medical Center Mart

    Saint Petersburg, 199178

    Suspended

  • RSBIH "Smolensk Regional Clinical Hospital"

    Smolensk, 214019

    Suspended

  • Federal State Budgetary Scientific Institution "Tomsk National Research Medical Centre of the Russia

    Tomsk, 634009

    Suspended

  • SBIH Republican Clinical Oncological Dispensary of the MoH of Republic Bashkortostan

    Ufa, 450054

    Suspended

Other trials in Russia

Italy5 sites, 5 recruiting

  • Ospedale San Raffaele

    Milan, 20123

    Stephanie Steidler, steidler.stephanie@hsr.it

    Francesco de Cobelli, MD

    Recruiting

  • Università Campus Bio-Medico di Roma

    Roma, 00128

    Frederica Spani, f.spani@unicampus.it

    Carlo Augusto Mallio, MD

    Recruiting

  • A.O.U. Senese Policlinico Santa Maria alle Scotte

    Siena, Siena, 53100

    Alfonso Cerase, MD

    Recruiting

  • Azienda Ospedaliera Universitaria di Trieste

    Trieste, Trieste, 34125

    Anna Ianza, +39403992120, anna.ianza@asugi.sanita.fvg.it

    Alessandra Guglielmi, MD

    Recruiting

  • Azienda Ospedaliera Universitaria Integrata Verona (Ospedale Borgo Roma)

    Verona, 37134

    Robertis Riccardo, riccardo.derobertis@hotmail.it

    Mirko D'Onofrio, MD

    Recruiting

Other trials in Italy

France2 sites, 1 recruiting

  • Groupe Hospitalier Pitie-Salpetriere

    Paris, 75013

    Withdrawn

  • CHU Strasbourg - Hôpital Hautepierre

    Strasbourg, 67200

    Samir Chenaf, samir.chenaf@chru-strasbourg.fr

    Sebastien MOLIERE, MD

    Recruiting

Other trials in France

Germany2 sites, 1 recruiting

  • Vivantes Klinikum Neukoelln

    Berlin, 12351

    Gabriella Baumann, gabriela.baumann@vivantes.de

    Thomas Albrecht, MD

    Recruiting

  • Universitaetsklinikum Tuebingen

    Tübingen, Baden-Wurttemberg, 72076

    Active, not recruiting

Other trials in Germany

Canada1 site

  • G. Kenneth Jansz Medical Professional Corporation

    Burlington, Ontario, L7N 3V2

    Withdrawn

Other trials in Canada

About this study

Official title: Prospective Evaluation of Potential Effects of Repeated Gadolinium-based Contrast Agent (GBCA) Administrations of the Same GBCA on Motor and Cognitive Functions in Neurologically Normal Adults in Comparison to a Non-GBCA Exposed Control Group

This study is a postmarketing requirement jointly carried out by four NDA holders (Bayer AG, Bracco, GE Healthcare and Guerbet) and the CRO IQVIA.

The study aims to create detailed images of the organs and tissue of the human body during x-ray, CT-scan or MRI investigations, doctors are using contrast media (a kind of dye) which can be given to patients by injection into a blood vessel or by mouth.

Read more

In this study researchers want to find out whether so called gadolinium-based contrast agents (GBCAs) have an effect on body movement and mental skills when given to participants multiple times within 5 years.

The study plans to enroll about 2076 participants suffering from a condition for which they are likely to have at least annually a MRI or another imaging examinations. Only adults up to 65 years will be considered to join this study. During the study duration of 5 years participants will receive annually a MRI or other imaging tests (such as CT-scan, x-ray) and will visit the study doctor at least 7 times for physical examinations, laboratory investigations and tests on body movement and mental skills.

Read the detailed description

The primary objective of the study is to 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 composite measure of motor and cognitive function among neurologically normal adults in comparison to a matched non-GBCA- exposed control group.

The secondary objectives comprise the assessment of the following endpoints in GBCA-exposed participants as compared to controls a) changes from baseline in composite measure of motor and cognitive function post-baseline on yearly basis (Years 1 to 4); b) changes from baseline in each individual test of motor and cognitive function on yearly basis (Years 1 to 5). Total Gd concentrations in blood and urine samples on yearly basis (Years 1 to 5) and adverse events will be collected as secondary objectives.

Of note : The study is considered interventional because of the addition of UE-MRI scans for all participants, as well as blood sampling and the administration of the motor and cognitive tests. The GBCA administered as part of the contrast-enhanced MR imaging in the experimental arms is not the intervention in this study. Neither the protocol nor the investigators assign patients to a specific GBCA as part of the study, making this part of the study observational rather than interventional. The participants were already scheduled, prior to study screening, to undergo CE-MRI as part of their clinical care. The choice of GBCA for the CE-MRI will be based on medical need and institutional usage of GBCA, independent of study participation.

Being tested
Motor Tests, Cognitive Tests, Unenhanced-MRI of the brain, Gadolinium Measurements, Gadoxetate disodium
Keywords
Motor function assessment, Cognitive function assessment, Magnetic Resonance Imaging (MRI), Gadolinium, Gadolinium-based contrast agent (GBCA), Gadolinium retention, Breast cancer, Prostate cancer, Hepatocellular carcinoma, Colorectal cancer, Neuroendocrine tumor, Branch-duct intraductal papillary mucinous neoplasm (IPMN) of the pancreas
Medical subject headings
Breast Neoplasms, Prostatic Neoplasms, Carcinoma, Hepatocellular, Colorectal Neoplasms, Neuroendocrine Tumors

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Motor TestsProcedure or surgery

    To assess motor function annually

  • Cognitive TestsProcedure or surgery

    To assess cognitive function annually

  • Unenhanced-MRI of the brainProcedure or surgery

    The UE-MRI of the brain will be performed at baseline and at the year 5 visit in order to exclude presence of a significant MRI abnormality

  • Gadolinium MeasurementsProcedure or surgery

    Blood samples and spontaneous urine specimens will be collected through the course of the study to measure Gd concentration

  • Gadoxetate disodiumDrug

    Also called Eovist, Primovist, BAY86-4873

    Administered as defined by the treating physician as part of routine clinical practice

  • Gadobenate dimeglumineDrug

    Also called MultiHance

    Administered as defined by the treating physician as part of routine clinical practice

  • GadodiamideDrug

    Also called Omniscan

    Administered as defined by the treating physician as part of routine clinical practice

  • Gadoterate meglumineDrug

    Also called Dotarem, Magnescope

    Administered as defined by the treating physician as part of routine clinical practice

  • GadobutrolDrug

    Also called BAY86-4875, Gadavist, Gadovist

    Administered as defined by the treating physician as part of routine clinical practice

  • GadoteridolDrug

    Also called ProHance

    Administered as defined by the treating physician as part of routine clinical practice

Study groups in NCT04373564
Study groupRoleWhat they receive
Linear GBCAsExperimentalAdult 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.
Receives: Procedure: Motor Tests; Procedure: Cognitive Tests; Procedure: Unenhanced-MRI of the brain; Procedure: Gadolinium Measurements; Drug: Gadoxetate disodium; Drug: Gadobenate dimeglumine; Drug: Gadodiamide
Macrocyclic GBCAsExperimentalAdult 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.
Receives: Procedure: Motor Tests; Procedure: Cognitive Tests; Procedure: Unenhanced-MRI of the brain; Procedure: Gadolinium Measurements; Drug: Gadoterate meglumine; Drug: Gadobutrol; Drug: Gadoteridol
No GBCA (Control arm)OtherAdult 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).
Receives: Procedure: Motor Tests; Procedure: Cognitive Tests; Procedure: Unenhanced-MRI of the brain; Procedure: Gadolinium Measurements

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change of motor function from baseline to year 5 in comparison to a matched non-GBCA-exposed control group

    The endpoint is a composite z score, defined as the weighted sum of the z scores of the individual tests

    Measured: At baseline, year 5

  2. Change in cognitive function from baseline to year 5 in comparison to a matched non-GBCA-exposed control group

    The endpoint is a composite z score, defined as the weighted sum of the z scores of the individual tests

    Measured: At baseline, year 5

Secondary outcomes (4)

  1. 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.

    The endpoint is a composite z score, defined as the weighted sum of the z scores of the individual tests

    Measured: At baseline, years 1, 2, 3, 4

  2. 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.

    The endpoint is a composite z score, defined as the weighted sum of the z scores of the individual tests

    Measured: At baseline, years 1, 2, 3, 4

  3. Number of participants with adverse events

    Measured: At baseline, years 1, 2, 3, 4, 5

  4. Total Gd concentrations (as measured in a central laboratory) in blood and urine samples taken from exposed and control participants at the time of the annual visit

    Measured: At baseline, years 1, 2, 3, 4, 5

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 May 2020
  2. Study start24 Mar 2021
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Other
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
2,076 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04373564
Sponsor's protocol ID
DGD-44-065
Other IDs
20405, GMRA-105, GE-041-081, IQVIA-ODYS-001-LZA45541
Acronym
ODYSSEY
Status last verified
Jan 2026
First submitted
30 Apr 2020
Last updated
22 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Motor Tests, Cognitive Tests and Unenhanced-MRI of the brain in people with Motor Function and Cognitive Function, run by Guerbet at 51 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 51 sites in United States, Brazil, South Korea, Russia, Italy and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Nathalie LE FUR, PhD (+33649351166, nathalie.lefur@guerbet.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of motor function from baseline to year 5 in comparison to a matched non-GBCA-exposed control group (time frame: At baseline, year 5). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04373564.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.

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