RECRUITING

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

Conditions

Motor Function Cognitive Function Contrast Media 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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2021-03-24

Study Completion:2028-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04373564

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 64 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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. * 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. * 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	* 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 * Participants with any previous exposure to a GBCA. * Participants with any contraindication to UE-MRI examinations.

Inclusion Criteria

Exclusion 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.
* 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.
* 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

* 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
* Participants with any previous exposure to a GBCA.
* Participants with any contraindication to UE-MRI examinations.

Contacts and Locations

Study Contact

Nathalie LE FUR, PhD

CONTACT

+33649351166

nathalie.lefur@guerbet.com

Frantz HEBERT

CONTACT

+33680249334

frantz.hebert@guerbet.com

Study Locations (Sites)

Scottsdale Medical Imaging, LLC

Scottsdale, Arizona, 85260

United States

Yale University School of Medicine

New Haven, Connecticut, 06520

United States

University of Chicago Medical Center

Chicago, Illinois, 60637

United States

Methodist Medical Center of Illinois

Peoria, Illinois, 61637

United States

Massachussets General Hospital

Boston, Massachusetts, 02114

United States

Boston University Medical Center

Boston, Massachusetts, 02118

United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215

United States

ActivMed Practices & Research, Inc.

Methuen, Massachusetts, 01844

United States

University of Massachusetts Memorial Medical Center

Worcester, Massachusetts, 01655

United States

Department of Radiology

Saint Louis, Missouri, 63110

United States

UNC School of Medicine

Chapel Hill, North Carolina, 27599

United States

Penn State Hershey Medical Center

Hershey, Pennsylvania, 17033

United States

Albert Einstein Healthcare Network

Philadelphia, Pennsylvania, 19141

United States

UT Southwestern Medical Center

Dallas, Texas, 75390

United States

MD Anderson Cancer Center

Houston, Texas, 77030

United States

University of Wisconsin

Madison, Wisconsin, 53792

United States

Collaborators and Investigators

Sponsor: Guerbet

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-03-24

Study Completion Date2028-12-31

Study Record Updates

Study Start Date2021-03-24

Study Completion Date2028-12-31

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

Motor Function
Cognitive Function
Contrast Media