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NCT05915728

PHASE3

A Study to Compare How Well Gadoquatrane Works and Its Safety With an Already Available Contrast Agent for MRI in People With Any Known or Suspected Problems of the Body (Except Brain or Spinal Cord-related Problems)

Sponsor: Bayer

View on ClinicalTrials.gov

Summary

Researchers are looking for a better way to help people with any known or suspected problems (except brain or spinal cord-related problems) scheduled for a "contrast-enhanced" Magnetic Resonance Imaging (MRI). MRI is used by doctors to create detailed images of the inside of the body to identify health problems. Sometimes doctors need to inject contrast agent into a patient's vein to perform a so called "contrast-enhanced" MRI (CE-MRI). Such CE-MRI examinations may support doctors to identify certain health problems or improve the evaluation. The contrast agents commonly used in MRI are gadolinium-based contrast agents (GBCAs). GBCAs contain a "rare earth" element called gadolinium (Gd). Gadoquatrane is a new contrast agent under development with a lower amount of Gd needed per CE-MRI. The main purpose of this study is to learn whether CE-MRI scans with gadoquatrane work better than MRI scans without the use of a contrast agent (GBCA). The researchers will compare the ability to detect known or suspected problems (except brain or spinal cord-related problems) with gadoquatrane-MRI scans to plain-MRI scans without the use of a contrast agent. The participants will undergo 2 MRI scans, one with gadoquatrane and one with currently used GBCA. Both contrast agents will be injected into the vein. Each participant will be in the study for between 6 and 42 days with up to 7 doctor visits. At the start or during the study, the doctors and their study team will: * take blood and urine samples * do physical examinations * check blood pressure and heart rate * review the MRI scans obtained in the study and decide on the diagnosis * ask the participants questions about how they are feeling and what adverse events they are having. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatments.

Official title: A Multicenter, Randomized, Prospective Double-blind, Cross-over Phase 3 Study to Evaluate the Efficacy and Safety of 0.04 mmol Gd/kg Body Weight of Gadoquatrane for MRI in Adults With Known or Suspected Pathology of Any Body Region (Except CNS), Compared to 0.1 mmol Gd/kg Approved Macrocyclic Gadolinium-based Contrast Agents (GBCAs)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

410

Start Date

2023-07-24

Completion Date

2024-06-01

Last Updated

2026-08-20

Healthy Volunteers

Conditions

Contrast Enhancement in Magnetic Resonance Imaging Non-central Nervous System Pathology

Interventions

DRUG

Gadoquatrane (BAY1747846)

0.04 mmol Gd/kg body weight, solution for intravenous injection, single dose

DRUG

Gadobutrol

Approved standard of care macrocyclic GBCA, 0.1 mmol Gd/kg body weight, solution for intravenous injection, single dose

DRUG

Gadoterate meglumine

Approved standard of care macrocyclic GBCA, 0.1 mmol Gd/kg body weight, solution for intravenous injection, single dose

DRUG

Gadoteridol

Approved standard of care macrocyclic GBCA, 0.1 mmol Gd/kg body weight, solution for intravenous injection, single dose

Inclusion Criteria: * Participant must be \>= 18 years of age inclusive, at the time of signing the informed consent form * Participants with a clinical indication for a contrast-enhanced MRI (including magnetic resonance angiography \[MRA\]), with any approved standard of care macrocyclic GBCA with proven efficacy, safety and tolerability in clinical routine CE-MRI/MRA (gadobutrol, gadoterate meglumine/ gadoteric acid or gadoteridol) that is used at the site for the indication, with known or suspected pathology of any body region, e.g. head and neck (except central nervous system \[CNS\]), thorax (including e.g. breast, heart, chest wall), abdomen (including e.g. liver, kidney, pancreas), pelvis (including e.g. prostate, uterus, ovaries), extremities (including upper and lower. * Participants who can undergo study-related procedures, including 2 contrast-enhanced MRI examinations (one with gadoquatrane and one with a comparator macrocyclic GBCA), as per participant and Investigator's judgement * Contraceptive use by female participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies: Is a woman of nonchildbearing potential (WONCBP) OR Is a woman of childbearing potential (WOCBP) and using an acceptable contraceptive method during the study intervention period (at a minimum of 24 hours after the last dose of study intervention). Exclusion Criteria: * Considered clinically unstable or has a concurrent/concomitant condition that may significantly alter image comparability between the 2 study MRIs or between study parameters (e.g. safety, pharmacokinetics \[PK\] parameters) or would not allow participation for the full planned study period, in the judgement of the investigator * Participants presenting with severe renal insufficiency, defined as an estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73 m\^2, derived from a serum or plasma creatinine sample obtained within 48 hours prior to the first contrast agent injection in the study * Participants with acute kidney injury (i.e., acute renal failure), regardless of eGFR * History of moderate to severe allergic-like reaction to any GBCA * Bronchial asthma considered unstable or who have had recent modification to their medical therapy * Receipt of any contrast agent \< 72 h prior to the study MRIs or planned to receive any contrast agent during the trial until 24 h +/- 4 h after the second study MRI * Planned or expected interventional diagnostic or therapeutic procedure (e.g. biopsy or surgery in the region of interest) or change in treatment (e.g. start of chemotherapy or antiangiogenic therapy, significant change in corticosteroids dose) that may significantly alter image comparability between the 2 MRIs or other study parameters (i.e. safety/adverse events \[AEs\] \[e.g. confounding AEs or safety events due to surgery or chemotherapy\], PK parameters), from the first study MRI up to 24 h after the second study MRI * Has received any investigational product within 30 days, or within 5 times half-life of the investigational product, whatever is shorter, prior to or concurrent with this study * Contraindications to the administration of macrocyclic GBCAs (depending on local product label), or history of adverse reaction to gadoquatrane * Any contraindication to MRI examinations based on institution policy and investigator's clinical judgement (e.g. some metallic implants or active implants)

Locations (85)

UAB Hospital - Radiology

Birmingham, Alabama, United States

Halo Diagnostics - Indian Wells

Indian Wells, California, United States

UC Irvine Medical Center

Orange, California, United States

University of Connecticut Health Center

Farmington, Connecticut, United States

Biogenix Molecular, LLC

Miami, Florida, United States

University of Missouri Hospital and Clinic - Neuroradiology

Columbia, Missouri, United States

Duke University School of Medicine - Early Phase Research Unit - Neurology

Durham, North Carolina, United States

Pennsylvania State University College of Medicine

Hershey, Pennsylvania, United States

Houston Methodist Hospital - Cardiology

Houston, Texas, United States

Fundacion Cientifica del Sur | Centro de Lomas de Zamora - Imaging Interventionism Department

Lomas de Zamora, Buenos Aires, Buenos Aires, Argentina

Instituto Alexander Fleming | Sede Central - Departamento de Diagnostico por Imagenes

CABA, Ciudad Auton. de Buenos Aires, Argentina

Sanatorio Otamendi | Imaging Diagnostic Center

Ciudad Autonoma de Buenos Aire, Ciudad Auton. de Buenos Aires, Argentina

Centro de Diagnostico Enrique Rossi | Departamento de Investigacion Clínica

Ciudad Autonoma de Buenos Aire, Ciudad Auton. de Buenos Aires, Argentina

Sanatorio Allende | Departamento de Investigación Clínica

Córdoba, Córdoba Province, Argentina

Clinica Universitaria Reina Fabiola | Consultorios Externos

Córdoba, Córdoba Province, Argentina

University Multiprofile Hospital for Active Treatment Dr Georgi Stranski Pleven | Surgery Department

Pleven, Pleven Province, Bulgaria

Multiprofile Hospital for Active Treatment Central Onco Hospital | Independent Medical Diagnostic Laboratory Mediscan

Plovdiv, Plovdiv Province, Bulgaria

University Multiprofile Hospital for Active Treatment Sveti Georgi | Base II - Imaging Diagnostic Department

Plovdiv, Plovdiv Province, Bulgaria

University Multiprofile Hospital For Active Treatment 'Alexandrovska' EAD

Sofia, Sofia City Province, Bulgaria

University Multiprofile Hospital for Active Treatment 'Sveta Ekaterina' EAD

Sofia, Sofia City Province, Bulgaria

University Multiprofile Hospital for Active Treatment St. Ivan Rilski | Radiology Department

Sofia, Sofia City Province, Bulgaria

Acibadem City Clinic | University Multiprofile Hospital for Active Treatment Tokuda - Radiology Department

Sofia, Bulgaria

University Hospital for Active Treatment Tsaritsa Joanna - ISUL | Radiology Department

Sofia, Bulgaria

Hôpital du Sacré-Cœur de Montréal | Radiology

Montreal, Quebec, Canada

Beijing Chaoyang Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Peking University First Hospital - Oncology Department

Beijing, Beijing Municipality, China

Beijing Hospital

Beijing, Beijing Municipality, China

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China

The First Affiliated Hospital of Jinan University

Guangzhou, Guangdong, China

Huai'an First People's Hospital, Nanjing Medical University

Huai'an, Jiangsu, China

Zhongda Hospital Southeast University

Nanjing, Jiangsu, China

West China Hospital Sichuan University

Chengdu, Sichuan, China

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

Fakultní nemocnice Brno - Klinika radiologie a nukleární medicíny

Brno, South Moravian, Czechia

Fakultní nemocnice Ostrava - Radiodiagnostický ústav

Ostrava, Czechia

Nemocnice Pardubickeho kraje, a.s., Pardubicka nemocnice

Pardubice, Czechia

Fakultni nemocnice Plzen - Lochotin

Pilsen, Czechia

Všeobecná fakultní nemocnice v Praze

Prague, Czechia

Fakultní Thomayerova nemocnice - klinicko-farmakologická jednotka

Praha 4 - Krc, Czechia

Hospices Civils de LYON

Bron, Auvergne-Rhône-Alpes, France

Centre Hospitalier Universitaire - Angers

Angers, Pays de la Loire Region, France

Centre Hospitalier Universitaire de Dijon

Dijon, France

Hôpital Bichat Claude Bernard - Service de radiologie

Paris, Île-de-France Region, France

Uniklinik Freiburg / Radiologie

Freiburg im Breisgau, Baden-Wurttemberg, Germany

Universitätsmedizin Göttingen - Institut für Diagnostische und Interventionelle Radiologie

Göttingen, Lower Saxony, Germany

Uniklinik Bonn / Radiologie

Bonn, North Rhine-Westphalia, Germany

Helios Herzzentrum Leipzig - Abteilung für diagnostische und interventionelle Radiologie

Leipzig, Saxony, Germany

Helios Klinikum Berlin-Buch - Klinik für Kardiologie - Kardio MRT

Berlin, State of Berlin, Germany

Universitätsklinikum Essen - Institut für Diagnostische und Interventionelle Radiologie und Neuroradiologie - 21197

Essen, Germany

Debreceni Egyetem Klinikai Kozpont - Onkologiai Klinika

Debrecen, Hungary

Pecsi Tudomanyegyetem Klinikai Kozpont

Pécs, Hungary

Trial Pharma Kft. Szeged

Szeged, Hungary

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, Lazio, Italy

Azienda Ospedaliero-Universitaria Sant'Andrea - UOC Radiologia

Rome, Lazio, Italy

Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia - Radiologia Diagnostica 1

Brescia, Lombardy, Italy

AULSS N. 2 Marca Trevigiana_Ospedale di Treviso - UOC Radiologia

Treviso, Veneto, Italy

Social Medical Corporation the Chiyukai foundation Fukuoka Wajiro Hospital

Fukuoka, Fukuoka, Japan

JCHO Kyushu Hospital

Kitakyushu, Fukuoka, Japan

Hospital of the University of Occupational and Environmental Health, Japan

Kitakyushu, Fukuoka, Japan

Hakodate Central General Hospital

Hakodate, Hokkaido, Japan

Hokkaido University Hospital

Sapporo, Hokkaido, Japan

Hyogo Prefectural Nishinomiya Hospital

Nishinomiya, Hyōgo, Japan

Public Central Hospital of Matto Ishikawa | Clinical Trial Management Office

Hakusan, Ishikawa-ken, Japan

National Hospital Organization Kanazawa Medical Center | Clinical Trial Management Office

Kanazawa, Ishikawa-ken, Japan

Takamatsu Red Cross Hospital

Takamatsu, Kagawa-ken, Japan

Kishiwada Tokushukai Hospital

Kishiwada, Osaka, Japan

Local Incorporated Administrative Agency Osaka City Hospital Organization Osaka City General Hospital

Osaka, Osaka, Japan

Japan Organization of Occupational Health and Safety Sanin Rosai Hospital

Yonago, Tottori, Japan

National Hospital Organization Kanmon Medical Center

Shimonoseki, Yamaguchi, Japan

NZOZ Kendron

Bialystok, Poland

Uniwersyteckie Centrum Kliniczne

Gdansk, Poland

Centra Medyczne Medyceusz

Lodz, Poland

Centrum Medycznym Gamma

Warsaw, Poland

Ajou University Hospital | Radiology

Suwon, Gyeonggi-do, South Korea

Seoul National University Hospital

Seoul, Seoul Teugbyeolsi, South Korea

Karolinska Universitetssjukhuset - Huddinge - Radiologi

Stockholm, Stockholm County, Sweden

Akademiska sjukhuset i Uppsala

Uppsala, Uppsala County, Sweden

Binali Yildirim Universitesi Mengucek Gazi EAH - Radyoloji

Erzincan, Turkey (Türkiye)

Koc Universitesi Tip Fakultesi - Radyoloji

Istanbul, Turkey (Türkiye)

Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi

Istanbul, Turkey (Türkiye)

Istanbul Universitesi Cerrahpasa-Cerrahpasa Tip Fakultesi

Istanbul, Turkey (Türkiye)

Ondokuz Mayis Universitesi Tip Fakultesi Saglik Uygulama ve Arastirma Merkezi

Samsun, Turkey (Türkiye)

Nottingham University Hospital

Nottingham, Nottinghamshire, United Kingdom

Queen Elizabeth University Hospital

Glasgow, Scotland, United Kingdom

Cardiff and Vale University Health Board |University Hospital of Wales - Clinical Research Facility

Cardiff, Wales, United Kingdom

Clinical Research Directory

A Study to Compare How Well Gadoquatrane Works and Its Safety With an Already Available Contrast Agent for MRI in People With Any Known or Suspected Problems of the Body (Except Brain or Spinal Cord-related Problems)

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (85)