Effect on Body Movement and Mental Skills in Patients Who Received Gadolinium-based Contrast Media for Magnetic Resonance Examination Multiple Times Within 5 Years
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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 64 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 65 years
- Procedures mentioned: MRI scans, X-rays, Injections, Physical exams, Urine samples
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "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."
- "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."
- "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."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Official eligibility 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.
Study sites (16)
AZ
- Scottsdale Medical Imaging, LLC · Scottsdale, AZ 85260 · Study contact · 4804254194 · comrkorn@imagingendpoints.comRonald Korn, MD · Principal investigatorMore trials in Scottsdale
CT
- Yale University School of Medicine · New Haven, CT 06520More trials in New Haven
IL
- University of Chicago Medical Center · Chicago, IL 60637Valentine Mildred · Study contact · 7737029812 · mvalenti@neurology.bsd.uchicago.eduAdil Javed, MD · Principal investigatorMore trials in Chicago
- Methodist Medical Center of Illinois · Peoria, IL 61637Teresa Osmulski · Study contact · 3096724808 · teresa.osmulski@unitypoint.orgPraveen Sudhindra, MD · Principal investigatorMore trials in Peoria
MA
- Massachussets General Hospital · Boston, MA 02114 · Study contact · 617-726-8396Mukesh Harisinghani, MD · Principal investigatorMore trials in Boston
- Boston University Medical Center · Boston, MA 02118More trials in Boston
- Beth Israel Deaconess Medical Center · Boston, MA 02215More trials in Boston
- ActivMed Practices & Research, Inc. · Methuen, MA 01844More trials in Methuen
- University of Massachusetts Memorial Medical Center · Worcester, MA 01655More trials in Worcester
MO
- Department of Radiology · St Louis, MO 63110More trials in St Louis
NC
- UNC School of Medicine · Chapel Hill, NC 27599More trials in Chapel Hill
PA
- Penn State Hershey Medical Center · Hershey, PA 17033Rebecca Jordan · Study contact · rjordan@pennstatehealth.psu.eduNabeel SARWANI, MD · Principal investigatorMore trials in Hershey
- Albert Einstein Healthcare Network · Philadelphia, PA 19141Meera Kasireddy · Study contact · 2154566370 · kasiredm@einstein.eduRyan Lee, MD · Principal investigatorMore trials in Philadelphia
TX
- UT Southwestern Medical Center · Dallas, TX 75390Sydney Haldeman Sydney · Study contact · sydney.haldeman@utsouthwestern.eduTakeshi Yokoo, MD · Principal investigatorMore trials in Dallas
- MD Anderson Cancer Center · Houston, TX 77030More trials in Houston
WI
- University of Wisconsin · Madison, WI 53792Nolan Caroll · Study contact · ncarroll@clinicaltrials.wisc.eduBruce Richard, MD · Principal investigatorMore trials in Madison