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) (Quanti OBR)

July 29, 2026 updated by: Bayer

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

410

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Argentina
- Buenos Aires
  - Lomas de Zamora, Buenos Aires, Buenos Aires, Argentina, B1832BRQ
    - Fundacion Cientifica del Sur | Centro de Lomas de Zamora - Imaging Interventionism Department
- Ciudad Auton. de Buenos Aires
  - CABA, Ciudad Auton. de Buenos Aires, Argentina, C1426
    - Instituto Alexander Fleming | Sede Central - Departamento de Diagnostico por Imagenes
  - Ciudad Autonoma de Buenos Aire, Ciudad Auton. de Buenos Aires, Argentina, C1115AAB
    - Sanatorio Otamendi | Imaging Diagnostic Center
  - Ciudad Autonoma de Buenos Aire, Ciudad Auton. de Buenos Aires, Argentina, C1425BEE
    - Centro de Diagnostico Enrique Rossi | Departamento de Investigacion Clínica
- Córdoba Province
  - Córdoba, Córdoba Province, Argentina, X5000JHQ
    - Sanatorio Allende | Departamento de Investigación Clínica
  - Córdoba, Córdoba Province, Argentina, X5004FHP
    - Clinica Universitaria Reina Fabiola | Consultorios Externos
Bulgaria
- - Sofia, Bulgaria, 1784
    - University Hospital for Active Treatment Tsaritsa Joanna - ISUL | Radiology Department
  - Sofia, Bulgaria, 1407
    - Acibadem City Clinic | University Multiprofile Hospital for Active Treatment Tokuda - Radiology Department
- Pleven Province
  - Pleven, Pleven Province, Bulgaria, 5809
    - University Multiprofile Hospital for Active Treatment Dr Georgi Stranski Pleven | Surgery Department
- Plovdiv Province
  - Plovdiv, Plovdiv Province, Bulgaria, 4002
    - Multiprofile Hospital for Active Treatment Central Onco Hospital | Independent Medical Diagnostic Laboratory Mediscan
  - Plovdiv, Plovdiv Province, Bulgaria, 4002
    - University Multiprofile Hospital for Active Treatment Sveti Georgi | Base II - Imaging Diagnostic Department
- Sofia City Province
  - Sofia, Sofia City Province, Bulgaria, 1431
    - University Multiprofile Hospital For Active Treatment 'Alexandrovska' EAD
  - Sofia, Sofia City Province, Bulgaria, 1431
    - University Multiprofile Hospital for Active Treatment 'Sveta Ekaterina' EAD
  - Sofia, Sofia City Province, Bulgaria, 1431
    - University Multiprofile Hospital for Active Treatment St. Ivan Rilski | Radiology Department
Canada
- Quebec
  - Montreal, Quebec, Canada, H4J 1C5
    - Hôpital du Sacré-Cœur de Montréal | Radiology
China
- Beijing Municipality
  - Beijing, Beijing Municipality, China, 100730
    - Beijing Hospital
  - Beijing, Beijing Municipality, China, 100020
    - Beijing Chaoyang Hospital, Capital Medical University
  - Beijing, Beijing Municipality, China, 100034
    - Peking University First Hospital - Oncology Department
- Guangdong
  - Guangzhou, Guangdong, China, 510515
    - Nanfang Hospital, Southern Medical University
  - Guangzhou, Guangdong, China, 510630
    - The First Affiliated Hospital of Jinan University
- Jiangsu
  - Huai'an, Jiangsu, China, 223300
    - Huai'an First People's Hospital, Nanjing Medical University
  - Nanjing, Jiangsu, China, 210009
    - Zhongda Hospital Southeast University
- Sichuan
  - Chengdu, Sichuan, China, 610041
    - West China Hospital Sichuan University
- Zhejiang
  - Wenzhou, Zhejiang, China, 325000
    - The First Affiliated Hospital of Wenzhou Medical University
Czechia
- - Ostrava, Czechia, 708 00
    - Fakultní nemocnice Ostrava - Radiodiagnostický ústav
  - Pardubice, Czechia, 530 03
    - Nemocnice Pardubickeho kraje, a.s., Pardubicka nemocnice
  - Pilsen, Czechia, 32300
    - Fakultni nemocnice Plzen - Lochotin
  - Prague, Czechia, 12808
    - Vseobecna Fakultni nemocnice v Praze
  - Praha 4 - Krc, Czechia, 140 00
    - Fakultní Thomayerova nemocnice - klinicko-farmakologická jednotka
- South Moravian
  - Brno, South Moravian, Czechia, 625 00
    - Fakultní nemocnice Brno - Klinika radiologie a nukleární medicíny
France
- - Dijon, France, 21079
    - Centre Hospitalier Universitaire de Dijon
- Auvergne-Rhône-Alpes
  - Bron, Auvergne-Rhône-Alpes, France, 69500
    - Hospices Civils de Lyon
- Pays de la Loire Region
  - Angers, Pays de la Loire Region, France, 49933
    - Centre Hospitalier Universitaire - Angers
- Île-de-France Region
  - Paris, Île-de-France Region, France, 75018
    - Hôpital Bichat Claude Bernard - Service de radiologie
Germany
- - Essen, Germany, 45147
    - Universitätsklinikum Essen - Institut für Diagnostische und Interventionelle Radiologie und Neuroradiologie - 21197
- Baden-Wurttemberg
  - Freiburg im Breisgau, Baden-Wurttemberg, Germany, 79106
    - Uniklinik Freiburg / Radiologie
- Lower Saxony
  - Göttingen, Lower Saxony, Germany, 37075
    - Universitätsmedizin Göttingen - Institut für Diagnostische und Interventionelle Radiologie
- North Rhine-Westphalia
  - Bonn, North Rhine-Westphalia, Germany, 53127
    - Uniklinik Bonn / Radiologie
- Saxony
  - Leipzig, Saxony, Germany, 04289
    - Helios Herzzentrum Leipzig - Abteilung für diagnostische und interventionelle Radiologie
- State of Berlin
  - Berlin, State of Berlin, Germany, 13125
    - Helios Klinikum Berlin-Buch - Klinik für Kardiologie - Kardio MRT
Hungary
- - Debrecen, Hungary, 4032
    - Debreceni Egyetem Klinikai Kozpont - Onkologiai Klinika
  - Pécs, Hungary, 7625
    - Pécsi Tudományegyetem Klinikai Központ
  - Szeged, Hungary, 6726
    - Trial Pharma Kft. Szeged
Italy
- Lazio
  - Rome, Lazio, Italy, 00168
    - Fondazione Policlinico Universitario Agostino Gemelli IRCCS
  - Rome, Lazio, Italy, 00189
    - Azienda Ospedaliero-Universitaria Sant'Andrea - UOC Radiologia
- Lombardy
  - Brescia, Lombardy, Italy, 25123
    - Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia - Radiologia Diagnostica 1
- Veneto
  - Treviso, Veneto, Italy, 31100
    - AULSS N. 2 Marca Trevigiana_Ospedale di Treviso - UOC Radiologia
Japan
- Fukuoka
  - Fukuoka, Fukuoka, Japan, 811-0213
    - Social Medical Corporation the Chiyukai foundation Fukuoka Wajiro Hospital
  - Kitakyushu, Fukuoka, Japan, 806-8501
    - JCHO Kyushu Hospital
  - Kitakyushu, Fukuoka, Japan, 807-8556
    - Hospital of the University of Occupational and Environmental Health, Japan
- Hokkaido
  - Hakodate, Hokkaido, Japan, 040-8585
    - Hakodate Central General Hospital
  - Sapporo, Hokkaido, Japan, 060-8648
    - Hokkaido University Hospital
- Hyōgo
  - Nishinomiya, Hyōgo, Japan, 662-0918
    - Hyogo Prefectural Nishinomiya Hospital
- Ishikawa-ken
  - Hakusan, Ishikawa-ken, Japan, 924-8588
    - Public Central Hospital of Matto Ishikawa | Clinical Trial Management Office
  - Kanazawa, Ishikawa-ken, Japan, 920-8650
    - National Hospital Organization Kanazawa Medical Center | Clinical Trial Management Office
- Kagawa-ken
  - Takamatsu, Kagawa-ken, Japan, 760-0017
    - Takamatsu Red Cross Hospital
- Osaka
  - Kishiwada, Osaka, Japan, 596-0042
    - Kishiwada Tokushukai Hospital
  - Osaka, Osaka, Japan, 534-0021
    - Local Incorporated Administrative Agency Osaka City Hospital Organization Osaka City General Hospital
- Tottori
  - Yonago, Tottori, Japan, 683-8605
    - Japan Organization of Occupational Health and Safety Sanin Rosai Hospital
- Yamaguchi
  - Shimonoseki, Yamaguchi, Japan, 752-8510
    - National Hospital Organization Kanmon Medical Center
Poland
- - Bialystok, Poland, 15-402
    - NZOZ Kendron
  - Gdansk, Poland, 80-214
    - Uniwersyteckie Centrum Kliniczne
  - Lodz, Poland, 91-053
    - Centra Medyczne Medyceusz
  - Warsaw, Poland, 01-785
    - Centrum Medycznym Gamma
South Korea
- Gyeonggi-do
  - Suwon, Gyeonggi-do, South Korea, 16499
    - Ajou University Hospital | Radiology
- Seoul Teugbyeolsi
  - Seoul, Seoul Teugbyeolsi, South Korea, 03080
    - Seoul National University Hospital
Sweden
- Stockholm County
  - Stockholm, Stockholm County, Sweden, 141 86
    - Karolinska Universitetssjukhuset - Huddinge - Radiologi
- Uppsala County
  - Uppsala, Uppsala County, Sweden, 751 85
    - Akademiska sjukhuset i Uppsala
Turkey (Türkiye)
- - Erzincan, Turkey (Türkiye), 24100
    - Binali Yildirim Universitesi Mengucek Gazi EAH - Radyoloji
  - Istanbul, Turkey (Türkiye), 34098
    - Istanbul Universitesi Cerrahpasa-Cerrahpasa Tip Fakultesi
  - Istanbul, Turkey (Türkiye), 34093
    - Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi
  - Istanbul, Turkey (Türkiye), 34010
    - Koc Universitesi Tip Fakultesi - Radyoloji
  - Samsun, Turkey (Türkiye), 55139
    - Ondokuz Mayis Universitesi Tip Fakultesi Saglik Uygulama ve Arastirma Merkezi
United Kingdom
- Nottinghamshire
  - Nottingham, Nottinghamshire, United Kingdom, NG7 2UH
    - Nottingham University Hospital
- Scotland
  - Glasgow, Scotland, United Kingdom, G51 4TF
    - Queen Elizabeth University Hospital
- Wales
  - Cardiff, Wales, United Kingdom, CF14 4XW
    - Cardiff and Vale University Health Board |University Hospital of Wales - Clinical Research Facility
United States
- Alabama
  - Birmingham, Alabama, United States, 35233
    - UAB Hospital - Radiology
- California
  - Indian Wells, California, United States, 92210
    - Halo Diagnostics - Indian Wells
  - Orange, California, United States, 92868
    - UC Irvine Medical Center
- Connecticut
  - Farmington, Connecticut, United States, 06032
    - University of Connecticut Health Center
- Florida
  - Miami, Florida, United States, 33165
    - Biogenix Molecular, LLC
- Missouri
  - Columbia, Missouri, United States, 65212
    - University of Missouri Hospital and Clinic - Neuroradiology
- North Carolina
  - Durham, North Carolina, United States, 27710
    - Duke University School of Medicine - Early Phase Research Unit - Neurology
- Pennsylvania
  - Hershey, Pennsylvania, United States, 17033
    - Pennsylvania State University College of Medicine
- Texas
  - Houston, Texas, United States, 77030
    - Houston Methodist Hospital - Cardiology

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.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Interventional Model: Crossover Assignment
Masking: Quadruple

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Gadoquatrane - Approved Macrocyclic GBCA Participants will receive one intravenous injection of gadoquatrane during MRI in Period 1, followed by one intravenous injection of any approved macrocyclic GBCA during MRI in Period 2.	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 Other Names: Gadoteric acid Drug: Gadoteridol Approved standard of care macrocyclic GBCA, 0.1 mmol Gd/kg body weight, solution for intravenous injection, single dose
Experimental: Approved Macrocyclic GBCA - Gadoquatrane Participants will receive one intravenous injection of any approved macrocyclic GBCA during MRI in Period 1, followed by one intravenous injection of gadoquatrane during MRI in Period 2.	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 Other Names: Gadoteric acid Drug: Gadoteridol Approved standard of care macrocyclic GBCA, 0.1 mmol Gd/kg body weight, solution for intravenous injection, single dose

Participant Group / Arm

Intervention / Treatment

Experimental: Gadoquatrane - Approved Macrocyclic GBCA

Participants will receive one intravenous injection of gadoquatrane during MRI in Period 1, followed by one intravenous injection of any approved macrocyclic GBCA during MRI in Period 2.

Drug: Gadoquatrane (BAY1747846)

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

Drug: Gadobutrol