Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Digestive System Diseases

Rare Diseases

Breast Neoplasms

Prostatic Neoplasms

Carcinoma

Carcinoma, Hepatocellular

Neuroendocrine Tumors

Neuroendocrine Tumor

Gastrointestinal Agents

All Drugs and Chemicals

Pancrelipase

Pancreatin

Gadolinium 1,4,7,10-tetraazacyclododecane-N,N',N'',N'''-tetraacetate

Chelating Agents

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.

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.

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).

Motor Tests

Cognitive Tests

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

Unenhanced-MRI of the brain

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

Gadolinium Measurements

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

Gadoxetate disodium

Gadobenate dimeglumine

Gadodiamide

Gadoterate meglumine

Gadobutrol

Gadoteridol

Nathalie LE FUR, PhD

Frantz HEBERT

Ronald Korn, MD

Valentine Mildred

Carla Harmath, MD

Teresa Osmulski

Praveen Sudhindra, MD

Mukesh Harisinghani, MD

Fishman Michael, MD

Joseph Yap

Leo Tsai, MD

Ricardo Sanchez, MD

Sara Schiller

Boris Nicolas Bloch, MD

Lauren Burke, MD

Rebecca Jordan

Nabeel SARWANI, MD

Meera Kasireddy

Ryan Lee, MD

Sydney Haldeman Sydney

Takeshi Yokoo, MD

Riya Nellippallil

Khaled Elsayes, MD

Nolan Caroll

Bruce Richard, MD

Patricia Moura

Joilda Batista de Almeida Rego, MD

Keyla Deucher

Cassiano Mateus Forcelini, MD

Brenda Santos

Ivan Pedrollo, MD

Marcela Maria Dutra

Israel Silva Maia, MD

Nicole Rabello

Luis Eduardo Werneck de Carvalho, MD

Luciana Cubas Volpe

Kathia Abdalla

Study Coordinator

Lis Gomes, MD

Gilberto Szarf

Ronaldo Baroni, MD

Samir Chenaf

Sebastien MOLIERE, MD

Alfonso Cerase, MD

Anna Ianza

Alessandra Guglielmi, MD

YoungJi Lee

Dong Joon Kim, MD

Hwasong Lee

Sang Soo Shin, MD

JinSil Choi

Won Chang, MD

Hayun Jung

Hae Woong Jeong, MD

Yun Jung

Jeong Heo, MD

Gyu Won Kim

JuYeon Cho,, MD

so hyun Kim

Joon Jeong, MD

DaJeong Kwon

Chang-hwan Choi, MD

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.

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.

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

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

Bayer AG (Sponsor)

Bracco (Sponsor)

GEHC (Sponsor)

Guerbet

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

The investigators use monopolar stimulators to determine and retain the tumor margin within 5mm from the posterior limb of the inner capsule in type III motor area glioma patients.

The investigators use bipolar stimulator according to the current standard surgery plan. After the positive points are identified by stimulator, the positive points are retained in order to preserve the motor function while all the non-positive points of the tumor are resected.

The awake neurosurgical procedure performed on the brain is to provide a real-time neurological functions monitoring in order to preserve the functions of brain to the greatest extent.

Awake craniotomy

Tao Jiang, MD and PhD

Yuhao Guo, MD

This study aims to compare the motor functions after traditional or a new surgical plan during awake glioma resection surgery.

This study concentrates on patients with type III motor area glioma. In the awake surgery, The investigators compare the new surgical plan, which the investigators use a monopolar stimulator to determine and retain the tumor margin within 5mm from the posterior limb of the inner capsule. For the traditional surgical plan, the investigators use bipolar stimulator according to the current standard surgery plan. After the positive points are identified by stimulator, the positive points are retained in order to preserve the motor function while all the non-positive points of the tumor are resected. This study is designed to determine whether the new surgical plan is more suitable for type III motor area glioma patients.

Strategic Intervention on Preserving Motor Function During Awake Craniotomy

Strategic Intervention on Preserving Motor Function With Application of Monopolar Stimulator During Awake Glioma Resection Surgery

The investigators do not plan to share individual participant data with other researchers

Motor function of the participants in new surgical plan group is better preserved and recover faster than the participants in traditional surgical group.The difference between the motor functions of two groups are analyzed using t-test or chi-square test according to the type of data.

Beijing Tiantan Hospital

Beijing Neurosurgical Institute

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Effect on Body Movement and Mental Skills in Patients Who Received Gadolinium-based Contrast Media for Magnetic Resonance Examination Multiple Times Within 5 Years	NCT04373564	Motor Function Cognitive Funct... Contrast Media	Motor Tests Cognitive Tests Unenhanced-MRI ... Gadolinium Meas... Gadoxetate diso... Gadobenate dime... Gadodiamide Gadoterate megl... Gadobutrol Gadoteridol	18 Years - 64 Years	Guerbet
Strategic Intervention on Preserving Motor Function During Awake Craniotomy	NCT05143788	Glioma	Awake craniotom...	18 Years - 65 Years	Beijing Neurosurgical Institute

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