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

April 3, 2024 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 the Central Nervous System (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 known or suspected 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 a 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 brain and spinal cord-related problems in 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

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

295

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 Contact

Name: Bayer Clinical Trials Contact
Phone Number: (+)1-888-84 22937
Email: clinical-trials-contact@bayer.com

Study Locations

Argentina
- - Córdoba, Argentina, X5000JHQ
    - Recruiting
    - Sanatorio Allende | Departamento de Investigación Clínica
  - Córdoba, Argentina, X5004FHP
    - Not yet recruiting
    - Clinica Universitaria Reina Fabiola | Consultorios Externos
- Buenos Aires
  - Lomas De Zamora, Buenos Aires, Buenos Aires, Argentina, B1832BRQ
    - Recruiting
    - Fundacion Cientifica del Sur | Centro de Lomas de Zamora - Imaging Interventionism Department
- Ciudad Auton. De Buenos Aires
  - Buenos Aires, Ciudad Auton. De Buenos Aires, Argentina, C1425BEE
    - Recruiting
    - Centro de Diagnóstico Dr. Enrique Rossi
  - Buenos Aires, Ciudad Auton. De Buenos Aires, Argentina, C1115AAB
    - Recruiting
    - Sanatorio Otamendi
  - Caba, Ciudad Auton. De Buenos Aires, Argentina, C1426
    - Recruiting
    - Instituto Alexander Fleming | Sede Central - Departamento de Diagnostico por Imagenes
Bulgaria
- - Plovdiv, Bulgaria, 4002
    - Recruiting
    - Multiprofile Hospital for Active Treatment Central Onco Hospital | Independent Medical Diagnostic Laboratory Mediscan
  - Plovdiv, Bulgaria, 4002
    - Recruiting
    - University Multiprofile Hospital for Active Treatment Sveti Georgi | Base II - Imaging Diagnostic Department
  - Sofia, Bulgaria, 1431
    - Not yet recruiting
    - UMHAT Prof. Dr Aleksandar Chirkov
  - Sofia, Bulgaria, 1407
    - Withdrawn
    - Acibadem City Clinic Multiprofile Hospital for Active Treatm
  - Sofia, Bulgaria, 1606
    - Not yet recruiting
    - UMHAT Tsaritsa Joanna-ISUL EAD Sofia
  - Sofia, Bulgaria, 1431
    - Not yet recruiting
    - University Multiprofile Hospital for Active Treatment St. Ivan Rilski | Radiology Department
  - Sofia, Bulgaria, 1431
    - Recruiting
    - UMHAT Alexandrovska EAD
  - Varna, Bulgaria, 9010
    - Recruiting
    - MHAT Sveta Marina EAD
Canada
- - London, Canada, N6A 5A5
    - Not yet recruiting
    - London Health Sciences Centre (LHSC) - University Hospital
- Ontario
  - London, Ontario, Canada, N6G 2M3
    - Not yet recruiting
    - St.Joseph's Health Care-London
  - Toronto, Ontario, Canada, M5G 2M9
    - Withdrawn
    - Princess Margaret Hospital-University Health Network
- Quebec
  - Montreal, Quebec, Canada, QC H4J 1C5
    - Recruiting
    - Hôpital du Sacré-Coeur de Montréal
China
- - Beijing, China, 100034
    - Recruiting
    - Peking University first hospital
  - Beijing, China, 100020
    - Recruiting
    - Beijing Chaoyang Hospital, Capital Medical University
  - Beijing, China, 100050
    - Recruiting
    - Beijing Tiantan Hospital, Captial Medical University
- Guangdong
  - Guangzhou, Guangdong, China, 510515
    - Recruiting
    - Nanfang Hospital, Southern Medical University
  - Guangzhou, Guangdong, China, 510120
    - Recruiting
    - Sun Yat-Sen Memorial Hosp. Sun Yat-Sen Univ.
  - Guangzhou, Guangdong, China, 510630
    - Recruiting
    - The First Affiliated Hospital of Jinan University
- Jiangsu
  - Huai'An, Jiangsu, China, 223300
    - Recruiting
    - Huai'an First People's Hospital, Nanjing Medical University
  - Nanjing, Jiangsu, China, 210009
    - Recruiting
    - Zhongda Hospital Southeast University
- Zhejiang
  - Wenzhou, Zhejiang, China, 325000
    - Recruiting
    - The First Affiliated Hospital of Wenzhou Medical University
Czechia
- - Brno, Czechia, 625 00
    - Recruiting
    - Fakultni nemocnice Brno
  - Ostrava, Czechia, 708 52
    - Recruiting
    - Fakultni nemocnice Ostrava
  - Pardubice, Czechia, 530 03
    - Not yet recruiting
    - Nemocnice Pardubickeho kraje, a.s., Pardubicka nemocnice
  - Plzen-Lochotin, Czechia, 323 00
    - Recruiting
    - Fakultni nemocnice Plzen - Lochotin
  - Prague, Czechia, 140 59
    - Recruiting
    - Fakultni Thomayerova Nemocnice
  - Praha 2, Czechia, 12808
    - Recruiting
    - Vseobecna Fakultni Nemocnice V Praze
France
- - La Tronche, France, 38700
    - Recruiting
    - Center Hospitalier Michallon - Grenoble
  - Pierre Benite, France, 69495
    - Recruiting
    - Centre Hospitalier Lyon Sud
  - Strasbourg Cedex, France, 67098
    - Recruiting
    - CHU STRASBOURG - Hôpital de Hautepierre
Germany
- Bayern
  - Augsburg, Bayern, Germany, 86156
    - Recruiting
    - Uniklinik Augsburg / Radiologie
- Nordrhein-Westfalen
  - Essen, Nordrhein-Westfalen, Germany, 45122
    - Not yet recruiting
    - Universitätsklinikum Essen
  - Münster, Nordrhein-Westfalen, Germany, 48145
    - Recruiting
    - St. Franziskus-Hospital GmbH
- Schleswig-Holstein
  - Kiel, Schleswig-Holstein, Germany, 24105
    - Recruiting
    - Uniklinik Kiel /Radiologie und Neuroradiologie
Hungary
- - Budapest, Hungary, 1145
    - Not yet recruiting
    - Semmelweis Egyetem Idegsebeszeti es Neurointervencios Klinika
  - Debrecen, Hungary, 4032
    - Recruiting
    - Debreceni Egyetem Klinikai Kozpont, Idegsebeszeti Klinika
  - Kistarcsa, Hungary, 2143
    - Withdrawn
    - Flor Ferenc Korhaz
  - Kisvarda, Hungary, 4600
    - Not yet recruiting
    - Szent Damjan Gorogkatolikus Korhaz
  - Miskolc, Hungary, 3526
    - Withdrawn
    - Borsod-Abauj-Zemplen Varmegyei Kozponti Korhaz es Egyetemi Oktatokorhaz, Kozponti Diagnosztikai Centrum
  - Pecs, Hungary, 7623
    - Recruiting
    - Idegsebeszeti Klinika
  - Szeged, Hungary, 6726
    - Recruiting
    - Trial Pharma Kft. Szeged
Italy
- Lazio
  - Roma, Lazio, Italy, 00189
    - Not yet recruiting
    - A.O.U. Sant'Andrea
- Lombardia
  - Bergamo, Lombardia, Italy, 24127
    - Recruiting
    - ASST Papa Giovanni XXIII
  - Milano, Lombardia, Italy, 20132
    - Not yet recruiting
    - Ospedale San Raffaele s.r.l.
- Puglia
  - Andria, Puglia, Italy, 70031
    - Recruiting
    - ASL Provincia di Barletta-Andria-Trani
Japan
- - Fukuoka, Japan, 810-8563
    - Recruiting
    - National Hospital Organization Kyushu Medical Center
  - Fukuoka, Japan, 811-0213
    - Recruiting
    - Social Medical Corporation the Chiyukai foundation Fukuoka Wajiro Hospital
  - Osaka, Japan, 534-0021
    - Recruiting
    - Osaka City General Hospital
- Fukuoka
  - Kitakyushu, Fukuoka, Japan, 807-8556
    - Not yet recruiting
    - Hospital of the University of Occupational and Environmental Health, Japan
- Hiroshima
  - Kure, Hiroshima, Japan, 737-8505
    - Recruiting
    - Kure Kyosai Hospital
- Hokkaido
  - Sapporo, Hokkaido, Japan, 060-8648
    - Not yet recruiting
    - Hokkaido University Hospital
- Hyogo
  - Nishinomiya, Hyogo, Japan, 662-0918
    - Recruiting
    - Hyogo Prefectural Nishinomiya Hospital
- Ishikawa
  - Kanazawa, Ishikawa, Japan, 920-8650
    - Recruiting
    - National Hospital Organization Kanazawa Medical Center | Clinical Trial Management Office
- Kagawa
  - Marugame, Kagawa, Japan, 763-8502
    - Recruiting
    - Japan Organization of Occupational Health and Safety Kagawa Rosai Hospital
- Kanagawa
  - Fujisawa, Kanagawa, Japan, 251-0041
    - Recruiting
    - Shonan Fujisawa Tokushukai Hospital
- Osaka
  - Kishiwada, Osaka, Japan, 596-0042
    - Recruiting
    - Kishiwada Tokushukai Hospital
- Yamaguchi
  - Shimonoseki, Yamaguchi, Japan, 752-8510
    - Recruiting
    - National Hospital Organization Kanmon Medical Center
Korea, Republic of
- - Busan, Korea, Republic of, 47392
    - Not yet recruiting
    - Inje University Busan Paik Hospital
- Gyeonggido
  - Suwon, Gyeonggido, Korea, Republic of, 443-721
    - Not yet recruiting
    - Ajou University Hospital
- Seoul Teugbyeolsi
  - Seoul, Seoul Teugbyeolsi, Korea, Republic of, 3080
    - Recruiting
    - Seoul National University Hospital
  - Seoul, Seoul Teugbyeolsi, Korea, Republic of, 138-736
    - Not yet recruiting
    - Asan Medical Center
  - Seoul, Seoul Teugbyeolsi, Korea, Republic of, 05030
    - Recruiting
    - Konkuk University Medical Center
Sweden
- - Stockholm, Sweden, 17177
    - Recruiting
    - Karolinska University Hospital, Solna Neuroradiology
  - Stockholm, Sweden, 14186
    - Recruiting
    - Karolinska University Hospital, Huddinge Neuroradiology
  - Uppsala, Sweden, 75185
    - Not yet recruiting
    - Uppsala University Hospital, Neuroradiology Department
Turkey
- - Ankara, Turkey, 06510
    - Not yet recruiting
    - Lokman Hekim Universitesi Tip Fakultesi - Radyoloji
  - Ankara, Turkey, 06532
    - Not yet recruiting
    - Hacettepe Universitesi Tip Fakultesi
  - Erzincan, Turkey, 24610
    - Recruiting
    - Binali Yildirim Universitesi Mengucek Gazi EAH - Radyoloji
  - Istanbul, Turkey, 34093
    - Recruiting
    - Istanbul Universitesi Istanbul Tip Fakultesi
  - Istanbul, Turkey, 34098
    - Recruiting
    - Istanbul Universitesi Cerrahpasa-Cerrahpasa Tip Fakultesi
  - Istanbul, Turkey, 34010
    - Recruiting
    - Koc Universitesi Tip Fakultesi - Radyoloji
  - Samsun, Turkey, 55139
    - Not yet recruiting
    - Ondokuz Mayis Uni Tip Fakultesi
United Kingdom
- - Cardiff, United Kingdom, CF14 4XW
    - Not yet recruiting
    - University Hospital of Wales
  - Edinburgh, United Kingdom, EH16 4SA
    - Withdrawn
    - Royal Infirmary of Edinburgh
  - London, United Kingdom, W6 8RF
    - Recruiting
    - Charing Cross Hospital
- Glasgow City
  - Glasgow, Glasgow City, United Kingdom, G51 4TF
    - Recruiting
    - Queen Elizabeth University Hospital
United States
- California
  - Indian Wells, California, United States, 92210
    - Recruiting
    - Halo Diagnostics
  - Murrieta, California, United States, 92562
    - Not yet recruiting
    - Biogenix Molecular, LLC
  - Orange, California, United States, 92868
    - Not yet recruiting
    - UC Irvine Medical Center
- Connecticut
  - Farmington, Connecticut, United States, 06032
    - Not yet recruiting
    - University of Connecticut Health Center
- Illinois
  - Chicago, Illinois, United States, 60611
    - Not yet recruiting
    - Northwestern University - Dept. of Radiology
- Michigan
  - Farmington Hills, Michigan, United States, 48334
    - Recruiting
    - Quest Research Institute Neuroradiology
- Minnesota
  - Rochester, Minnesota, United States, 55905
    - Not yet recruiting
    - Mayo Clinic - Rochester
- Missouri
  - Columbia, Missouri, United States, 65212
    - Recruiting
    - University of Missouri Hospital and Clinic - Neuroradiology
- North Carolina
  - Durham, North Carolina, United States, 27710
    - Not yet recruiting
    - Duke University School of Medicine
- Pennsylvania
  - Hershey, Pennsylvania, United States, 17033
    - Not yet recruiting
    - Penn State Milton S. Hershey Medical Center
- South Carolina
  - Charleston, South Carolina, United States, 29425
    - Withdrawn
    - Medical University of South Carolina - Radiology
- Texas
  - Dallas, Texas, United States, 75235-3858
    - Withdrawn
    - University of Texas Southwestern Medical Center

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 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, for a known or suspected CNS pathology
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 before or during MRI in Period 1, followed by one intravenous injection of any approved macrocyclic GBCA before or 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 before or during MRI in Period 1, followed by one intravenous injection of gadoquatrane before or 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 before or during MRI in Period 1, followed by one intravenous injection of any approved macrocyclic GBCA before or during MRI in Period 2.

Drug: Gadoquatrane (BAY1747846)

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

Drug: Gadobutrol