Single administration at a dose of 0.1 mmol/kg

Gadobutrol (Gadovist, BAY86-4875)

Gadopentetate Dimeglumine (Magnevist, BAY86-4882)

Bayer Study Director

The purpose of the study is to look at the safety (what are the side effects) and efficacy (how well does it work) of gadobutrol when used for taking MR images of the body/extremities regions. The results of the MRI with gadobutrol injection will be compared to the results of MR images taken without contrast and with the results of the MR images taken with Magnevist.

Gadobutrol Magnevist-controlled Body Study

A Multi-center/Multi-national, Randomized, Controlled, Single-blind, Group Comparison Phase 3 Study to Determine the Efficacy and Safety of Gadobutrol 1.0 Molar in Comparison to Magnevist Following Single Injection in Patients Referred for Contrast-enhanced MRI of the Body/Extremities Regions (Breast, Heart, Abdomen, Kidney, Pelvis, or Extremities)

Bayer

Therapeutic Area Head

Neoplasms

All Conditions

Symptoms and General Pathology

Nervous System Diseases

Rare Diseases

Glioma

Disease Progression

Neovascularization, Pathologic

Supratentorial Neoplasms

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

Repeated Measurements of the relative regional cerebral blood volume variation through an every 6 monts Magnetic Resonance Imaging use.

Repeated Measurements of the relative regional cerebral blood volume

Nicolas MENJOT DE CHAMPFLEUR, MD, PhD

Retrospective longitudinal follow-up in patients with diffuse low-grade glioma with multimodal MRI assessment

Longitudinal MRI Assessment in Patients With Diffuse Low-grade Gliomas

Retrospective Longitudinal Follow-up in Patients With Diffuse Low-grade Glioma With Multimodal MRI Assessment

Longitudinal variation of the relative regional cerebral blood volume from first pass perfusion imaging data for each MRI performed

University Hospital, Montpellier

Skin and Connective Tissue Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Digestive System 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

Gland and Hormone Related Diseases

Thyroid Diseases

Thyroid Neoplasms

Thyroid Nodule

Endocrine System Diseases

Endocrine Gland Neoplasms

Head and Neck Neoplasms

Integrated scoring method and up-and-down scoring method

Contrast-enhanced Ultrasound

Jingliang Ruan, PhD

Xiaming Ye, Master

Baoming Luo, Professor

Contrast-enhanced ultrasound (CEUS) can sensitively show the blood perfusion characteristics of thyroid nodules, which is a useful supplement to gray-scale ultrasound. However, there is no standard combined diagnostic method of gray-scale ultrasound and CEUS. Therefore, the aim of this study was to compare the diagnostic performance of the integrated scoring method and the up-and-down scoring method. This study was a multicenter retrospective clinical study and followed the Standards for Reporting of Diagnostic Accuracy Studies (version 2015). Inclusion criteria: 1) participants with at least one thyroid nodule larger than 5 mm confirmed by conventional ultrasound; 2) participants underwent gray-scale ultrasound, contrast-enhanced ultrasound and fine needle aspiration biopsy of the thyroid nodule successively; 3) participants have a final diagnosis of benign or malignant. Exclusion criteria included: 1) participants with cytologic findings of Bethesda I, III, or IV without definitive benign or malignant pathologic findings; 2) participants with a history of thyroid fine needle aspiration, ablation or surgery; 3) participants with low quality ultrasound images (e.g., severe artifacts or low image resolution). According to the American College of Radiology Thyroid Imaging Reporting and Data System, only one thyroid nodule with the highest point was included in each participant. A total of 600 participants from January 2018 to December 2022 were consecutively included in Sun Yat-sen Memorial Hospital of Sun Yat-sen University to form a training set (average age 48 years; Range 24-81 years old). A total of 200 subjects with thyroid nodules from January 2022 to December 2022 were consecutively included to form an external validation set in Houjie Hospital of Dongguan City, Guangdong Province (mean age 46 years; Range 30-74 years). The malignant risk of enrolled thyroid nodules and the necessity of biopsy were evaluated by integrated scoring method and up-and-down scoring method, respectively. The diagnostic performance and unnecessary biopsy rate of the above two methods were calculated and compared.

CEUS Improves the Diagnostic Performance of SRSS of Thyroid Carcinoma

Contrast-enhanced Ultrasound Improves the Diagnostic Performance of Sonographic Risk Stratification System of Thyroid Carcinoma: Comparison Between Integrated Scoring Method and Up-and-down Scoring Method

Data generated or analyzed during the study are available from the principal investigator by request.

Sensitivity, specificity, positive predictive value, negative predictive value, area under the curve

The unnecessary biopsy rate was defined as a percentage of the number of benign nodules among biopsy-indicated nodules in the total nodules.

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Principal Investigator

Kidney Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Joachim Hohmann, MD

Retrospective comparison of complex cystic renal lesions which are found with computed tomography (CT) and were controlled with contrast enhanced ultrasound (CEUS).

All subjects receive an contrast enhanced CT due to different clinical indications. When a complex cystic renal lesion is found an evaluation with CEUS is performed. The CEUS protocol included a native baseline examination of both kidneys. After a bolus injection of 1.5 ml SonoVue (Bracco, Milano, Italy) an examination of the affected kidneys is performed over a time period of at least three minutes. An optional dose will be given when the initial examination is not conclusive, e. g. when the arterial phase is partly missed. When both examinations are done the lesions were classified using the Bosniak classification system and a comparison of both methods will be done.

CT Versus CEUS Findings of Complex Cystic Renal Lesions

Complex Cystic Renal Lesions: Evaluation of Computed Tomography Findings With Contrast Enhanced Ultrasound in Terms of the Bosniak Classification System.

University Hospital, Basel, Switzerland

Dr. Joachim Hohmann

Neoplasm Metastasis

Colorectal Neoplasms

Neoplastic Processes

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Hematinics

Liver Extracts

Contrast-enhanced MRI with an i.v. application of Primovist in the approved dosage

Primovist MRI

Contrast-enhanced MRI with an i.v. application of an approved extracellular contrast medium in the approved dosage

Extracellular contrast media (ECCM) MRI

Contrast-enhanced 3 phase multidetector CT with an i.v. application of an approved iodinated contrast medium in the approved dosage

Contrast-enhanced CT

Patients with a history of colorectal cancer and known or suspected liver metastases who are scheduled for contrast-enhanced tomographic imaging will be included in this study. After randomization to either Primovist-enhanced MRI, extracellular contrast media (ECCM)-enhanced MRI or contrast-enhanced (CE)-CT outcomes and resource needs of the diagnostic work-up and treatment will be evaluated for each of the three imaging modalities. Main objectives of the study are to assess the proportion of patients for whom further imaging is required to come to a therapy decision and to evaluate the proportion of patients with intraoperatively modified surgical plans after Primovist-enhanced MRI as compared to ECCM-enhanced MRI and CE-CT.

Health Economic Evaluation of Primovist-enhanced Liver MRI

Multi-center, Randomized Comparison Study to eVALUatE Outcomes and Resource Needs of Imaging and Treatment Following Primovist-enhanced MRI of the Liver in Comparison to Extracellular Contrast Media (ECCM)-Enhanced MRI and Contrast-enhanced Computed Tomography (CT) in Patients With a History of Colorectal Cancer and Known or Suspected Metachronous Liver Metastases.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Gadobutrol Magnevist-controlled Body Study	NCT01050829	Magnetic Resona...	Gadobutrol (Gad... Gadopentetate D...	20 Years -	Bayer
Longitudinal MRI Assessment in Patients With Diffuse Low-grade Gliomas	NCT04346472	Low-grade Gliom...	Repeated Measur...	18 Years -	University Hospital, Montpellier
Gadobutrol Magnevist-controlled Body Study	NCT01050829	Magnetic Resona...	Gadobutrol (Gad... Gadopentetate D...	20 Years -	Bayer
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
CEUS Improves the Diagnostic Performance of SRSS of Thyroid Carcinoma	NCT06146764	Thyroid Nodule Thyroid Carcino...	Contrast-enhanc...	18 Years -	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
CT Versus CEUS Findings of Complex Cystic Renal Lesions	NCT01159717	Kidney Neoplasm... Computed Tomogr... Ultrasonography Contrast Media		18 Years -	University Hospital, Basel, Switzerland
Health Economic Evaluation of Primovist-enhanced Liver MRI	NCT00764621	Colorectal Neop... Neoplasm Metast...	Primovist MRI Extracellular c... Contrast-enhanc...	18 Years -	Bayer
Longitudinal MRI Assessment in Patients With Diffuse Low-grade Gliomas	NCT04346472	Low-grade Gliom...	Repeated Measur...	18 Years -	University Hospital, Montpellier

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