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NCT04373564 | RECRUITING | Motor Function

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

Guerbet

Brief 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 dye) which can be given to patients by injection into a blood vessel or by mouth. 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.

Condition or disease

Motor Function

Cognitive Function

Contrast Media

Intervention/treatment

Motor Tests

Cognitive Tests

Unenhanced-MRI of the brain

Gadolinium Measurements

Gadoxetate disodium

Gadobenate dimeglumine

Gadodiamide

Gadoterate meglumine

Gadobutrol

Gadoteridol

Phase

PHASE4

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 2076 participants
Masking : NONE
Primary Purpose : OTHER
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
Actual Study Start Date : 2021-03-24
Estimated Primary Completion Date : 2028-12-31
Estimated Study Completion Date : 2028-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 64 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * 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.
    • 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
      Exclusion Criteria
      • * 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
      • * 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.
Effect on Body Movement and Mental Skills in Patients Who Received Gadolinium-based Contrast Media for Magnetic Resonance Examination Multiple Times Within 5 Years

Location Details

NCT04373564

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Arizona

Scottsdale Medical Imaging, LLC

Scottsdale, Arizona, United States, 85260

WITHDRAWN

United States, Connecticut

Yale University School of Medicine

New Haven, Connecticut, United States, 06520

RECRUITING

United States, Illinois

University of Chicago Medical Center

Chicago, Illinois, United States, 60637

RECRUITING

United States, Illinois

Methodist Medical Center of Illinois

Peoria, Illinois, United States, 61637

RECRUITING

United States, Massachusetts

Massachussets General Hospital

Boston, Massachusetts, United States, 02114

RECRUITING

United States, Massachusetts

Boston University Medical Center

Boston, Massachusetts, United States, 02118

RECRUITING

United States, Massachusetts

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States, 02215

RECRUITING

United States, Massachusetts

ActivMed Practices & Research, Inc.

Methuen, Massachusetts, United States, 01844

RECRUITING

United States, Massachusetts

University of Massachusetts Memorial Medical Center

Worcester, Massachusetts, United States, 01655

WITHDRAWN

United States, Missouri

Department of Radiology

St Louis, Missouri, United States, 63110

RECRUITING

United States, North Carolina

UNC School of Medicine

Chapel Hill, North Carolina, United States, 27599

RECRUITING

United States, Pennsylvania

Penn State Hershey Medical Center

Hershey, Pennsylvania, United States, 17033

RECRUITING

United States, Pennsylvania

Albert Einstein Healthcare Network

Philadelphia, Pennsylvania, United States, 19141

RECRUITING

United States, Texas

UT Southwestern Medical Center

dallas, Texas, United States, 75390

NOT YET RECRUITING

United States, Texas

MD Anderson Cancer Center

Houston, Texas, United States, 77030

RECRUITING

United States, Wisconsin

University of Wisconsin

Madison, Wisconsin, United States, 53792

TERMINATED

Brazil, Federal District

Santa Marta Hospital

Taguatinga, Federal District, Brazil, 72025-110

RECRUITING

Brazil, Rio Grande do Norte

North-Rio-Grandense League Against Cancer

Natal, Rio Grande do Norte, Brazil, 59075-740

RECRUITING

Brazil, Rio Grande do Sul

Mederi Institute for Research and Health

Passo Fundo, Rio Grande do Sul, Brazil, 99010-120

RECRUITING

Brazil, Rio Grande do Sul

Moinhos de Vento Hospital

Porto Alegre, Rio Grande do Sul, Brazil, 90035-001

RECRUITING

Brazil, Santa Catarina

Baía Sul Teaching and Research Institute (IEP)

Florianópolis, Santa Catarina, Brazil, 88020-210

RECRUITING

Brazil, São Paulo

CEMEC - Oncology

São Bernardo do Campo, São Paulo, Brazil, 09715-090

RECRUITING

Brazil, São Paulo

São José do Rio Preto Regional Faculty of Medicine Foundation

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

RECRUITING

Brazil, São Paulo

CPCLIN - Centro de Pesquisas Clínicas Ltda.

São Paulo, São Paulo, Brazil, 01228-200

RECRUITING

Brazil, São Paulo

Albert Einstein Brazilian Israeli Charitable Society

São Paulo, São Paulo, Brazil, 05652000

WITHDRAWN

Brazil,

CEMEC - Oncology

São Bernardo do Campo, Brazil,

WITHDRAWN

Canada, Ontario

G. Kenneth Jansz Medical Professional Corporation

Burlington, Ontario, Canada, L7N 3V2

WITHDRAWN

France,

Pitie-Salpetriere Hospital Group

Paris, France, 75013

RECRUITING

France,

Strasbourg University Hospital - Hautepierre Hospital

Strasbourg, France, 67200

ACTIVE NOT RECRUITING

Germany, Baden-Württemberg

Universitaet clinic tuebing

Tübingen, Baden-Württemberg, Germany, 72076

RECRUITING

Italy,

A.O.U. Senees Policy-step Marywide Mary

Siena, Italy, 53100

RECRUITING

Italy,

University Hospital of Trieste

Trieste, Italy, 34125

SUSPENDED

Russia,

BHI of Omsk region "Clinical Oncology Dispensary"

Omsk, Russia, 644013

SUSPENDED

Russia,

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

Saint Petersburg, Russia, 192019

SUSPENDED

Russia,

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

Saint Petersburg, Russia, 197341

SUSPENDED

Russia,

LLC Medical Center Mart

Saint Petersburg, Russia, 199178

SUSPENDED

Russia,

RSBIH "Smolensk Regional Clinical Hospital"

Smolensk, Russia, 214019

SUSPENDED

Russia,

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

Tomsk, Russia, 634009

SUSPENDED

Russia,

SBIH Republican Clinical Oncological Dispensary of the MoH of Republic Bashkortostan

Ufa, Russia, 450054

RECRUITING

South Korea, Toys

Hallym University Chuncheon Sacred Heart Hospital

Chuncheon, Toys, South Korea, 24253

RECRUITING

South Korea, Ravy

Chonnam National University Hospital

Gwangju, Gyeongggi-do, South Korea, 61469

RECRUITING

South Korea, Ravy

Seoul National University Bundang Hospital

Seongnam-shi, Gyeongggi-do, South Korea, 13620

RECRUITING

South Korea,

Inje University Busan Paik Hospital

Busan, South Korea, 47392

RECRUITING

South Korea,

Pusan National University Hospital

Busan, South Korea, 49241

RECRUITING

South Korea,

Chosun University Hospital

Gwangju, South Korea, 61453

RECRUITING

South Korea,

Gangnam Severance Hospital, Yonsei University Health System

Seoul, South Korea, 06273

RECRUITING

South Korea,

Chung-Ang University Hospital

Seoul, South Korea, 06973