A Study to Learn How Gadoquatrane Moves Into, Through, and Out of the Body and How Safe it is in Children (From Birth to <18 Years), Who Will Undergo a Contrast Enhanced MRI (Quanti Pediatric)

A Multicenter, Prospective, Open-label Study to Evaluate the Pharmacokinetics and Safety of Gadoquatrane in Pediatric Participants (From Birth to <18 Years) Undergoing Contrast-enhanced Magnetic Resonance Imaging (CE-MRI)

Researchers are looking for a better way to help children under the age of 18 with any known or suspected 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 "contrast-enhanced" MRI (CE-MRI). Such CE-MRI examinations may support doctors to identify certain health problems or improve their evaluation.

The contrast agents commonly used in MRI are gadolinium-based contrast agents (GBCAs). GBCAs contain a "rare earth" element called gadolinium (Gd), which is needed for the increase in signal intensity and contrast in MRI. The gadolinium in these contrast agents is caged in a molecule (chelate complex). Researchers are developing new contrast agents with a lower amount of Gd needed per CE-MRI investigation. Gadoquatrane is one of these new contrast agents. It has been tested in several studies previously.

The main purpose of this study is to learn how gadoquatrane moves into, through, and out of the body and how safe it is in children. The researchers will measure the amount of gadoquatrane in the blood at different time points after a single injection.

The participants will undergo an MRI examination and receive gadoquatrane once at a dose of 0.04 mmol Gd/kg (corresponding to 0.1 mL/kg). It is injected into the participant's vein (also called an intravenous injection) during the MRI examination.

Each participant will be in the study for between 8 and 38 days with up to 5 doctor visits, including the screening phase of up to 28 days with no more than 2 visits. Once a participant has received the injection of gadoquatrane, the remaining study duration is 7 (±1) days.

At the start or during the study, the doctors and their study team will:

• check the weight and height of the participant,
• ask for information including age and medical history,
• take participants' blood samples,
• ask participants and/or their guardians questions about medicines they are taking,
• check blood pressure, heart rate and body temperature,
• check the area where the participants had the intravenous injection,
• do pregnancy tests in girls of childbearing age,
• 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: Children; Contrast Enhancement in Magnetic Resonance Imaging
• Intervention / Treatment: Drug: Gadoquatrane (BAY1747846)

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 3

Contacts and Locations

• 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
    • Not yet recruiting
    • Sanatorio Allende | Departamento de Investigación Clínica
  • Córdoba, Argentina, X5004FHP
    • Recruiting
    • Clinica Universitaria Reina Fabiola | Consultorios Externos
  • Ciudad Auton. De Buenos Aires
    • Buenos Aires, Ciudad Auton. De Buenos Aires, Argentina, C1425BEE
      • Not yet recruiting
      • Centro de Diagnóstico Dr. Enrique Rossi
• Belgium
  • Brussel, Belgium, 1090
    • Withdrawn
    • UZ Brussel - Pediatrie
• Bulgaria
  • Plovdiv, Bulgaria, 4002
    • Not yet recruiting
    • Multiprofile Hospital for Active Treatment Central Onco Hospital | Independent Medical Diagnostic Laboratory Mediscan
  • Plovdiv, Bulgaria, 4000
    • Recruiting
    • University Multiprofile Hospital for Active Treatment Sveti Georgi | Base II - Radiology Department
  • Sofia, Bulgaria, 1784
    • Not yet recruiting
    • University Hospital for Active Treatment Tsaritsa Joanna - ISUL | Radiology Department
  • Sofia, Bulgaria, 1431
    • Not yet recruiting
    • University Multiprofile Hospital for Active Treatment St. Ivan Rilski | Radiology Department
• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 1X8
      • Not yet recruiting
      • The Hospital for Sick Children (SickKids)
• China
  • Beijing, China, 100045
    • Recruiting
    • Beijing Children's Hospital, Capital Medical University
  • Guangdong
    • Guangzhou, Guangdong, China, 510280
      • Recruiting
      • Zhujiang Hospital of Southern Medical University
  • Sichuan
    • Chengdu, Sichuan, China, 610066
      • Not yet recruiting
      • West China Second University Hospital
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310056
      • Recruiting
      • The Children's Hospital Zhengjiang University School of Med.
• Czechia
  • Ostrava, Czechia, 708 52
    • Recruiting
    • Fakultni nemocnice Ostrava
  • Plzen, Czechia, 304 60
    • Recruiting
    • Fakultni nemocnice Plzen - Lochotin
• Germany
  • Berlin, Germany, 13353
    • Recruiting
    • Charité - Universitätsmedizin Berlin, Campus Virchow-Klinikum, Pädiatrische Radiologie
  • Nordrhein-Westfalen
    • Münster, Nordrhein-Westfalen, Germany, 48149
      • Withdrawn
      • Universitätsklinikum Münster - Klinik für Radiologie, Kinderradiologie
  • Sachsen
    • Dresden, Sachsen, Germany, 01307
      • Not yet recruiting
      • Universitätsklinikum Carl Gustav Carus an der TU Dresden - Diagnostische und Interventionelle Radiologie / Kinderradiologie
    • Leipzig, Sachsen, Germany, 04103
      • Recruiting
      • Universitätsklinikum Leipzig - Institut für Kinderradiologie
  • Sachsen-Anhalt
    • Halle (Saale), Sachsen-Anhalt, Germany, 06120
      • Recruiting
      • Universitätsklinkum Halle (Saale) - Universitätsklinik und Poliklinik für Radiologie, Kinderradiologie
  • Thüringen
    • Jena, Thüringen, Germany, 07747
      • Recruiting
      • Universitätsklinikum Jena - Institut für Diagnostische und Interventionelle Radiologie, Kinderradiologie
• Hungary
  • Budapest, Hungary, 1094
    • Withdrawn
    • Semmelweis Egyetem - II. Sz. Gyermekgyogyaszati Klinika - Neuro-onkologiai Osztaly
  • Budapest, Hungary, 1145
    • Withdrawn
    • Orszagos Mentalis, Ideggyogyaszati es Idegsebeszeti Intezet - Gyermekidegsebeszeti Osztaly
  • Miskolc, Hungary, 3526
    • Withdrawn
    • B.-A.-Z. MKK es EOK - Velkey Laszlo Gyermek Eu Kp - Gyermek Onko-haematologiai es Csontvelo Transzplantacios Osztaly
  • Pecs, Hungary, 7623
    • Withdrawn
    • Pecsi Tudomanyegyetem Klinikai Kozpont - Gyermekgyogyaszati Klinika - Onkohaematologiai Osztaly
• Italy
  • Lazio
    • Roma, Lazio, Italy, 00165
      • Not yet recruiting
      • IRCCS Ospedale Pediatrico Bambino Gesù
  • Liguria
    • Genova, Liguria, Italy, 16147
      • Not yet recruiting
      • IRCCS Istituto Giannina Gaslini
  • Lombardia
    • Milano, Lombardia, Italy, 20122
      • Not yet recruiting
      • Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico
• Japan
  • Nara, Japan, 630-8581
    • Withdrawn
    • Nara Prefecture General Medical Center
  • Shizuoka, Japan, 420-8660
    • Recruiting
    • Shizuoka Children's Hospital
  • Aichi
    • Nagoya, Aichi, Japan, 460-0001
      • Recruiting
      • National Hospital Organization Nagoya Medical Center
    • Nagoya, Aichi, Japan, 453-8511
      • Recruiting
      • Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital
  • Hokkaido
    • Sapporo, Hokkaido, Japan, 060-8648
      • Not yet recruiting
      • Hokkaido University Hospital
  • Kanagawa
    • Isehara, Kanagawa, Japan, 259-1193
      • Not yet recruiting
      • Tokai University Hospital
    • Yokohama, Kanagawa, Japan, 232-8555
      • Recruiting
      • Kanagawa Children's Medical Center
  • Tochigi
    • Shimotsuke, Tochigi, Japan, 329-0498
      • Recruiting
      • Jichi Medical University Hospital
  • Tokyo
    • Bunkyo-ku, Tokyo, Japan, 113-8431
      • Recruiting
      • Juntendo University Hospital
    • Bunkyo-ku, Tokyo, Japan, 113-8655
      • Not yet recruiting
      • The University of Tokyo Hospital
    • Fuchu, Tokyo, Japan, 183-8561
      • Recruiting
      • Tokyo Metropolitan Hospital Organization Tokyo Metropolitan Children's Medical Center
    • Setagaya-ku, Tokyo, Japan, 157-8535
      • Recruiting
      • National Center for Child Health and Development
• Poland
  • Lodz, Poland, 93-338
    • Not yet recruiting
    • Instytut Centrum Zdrowia Matki Polki
  • Warszawa, Poland, 04-730
    • Recruiting
    • Instytut "Pomnik - Centrum Zdrowia Dziecka"
• Sweden
  • Solna, Sweden, 17164
    • Not yet recruiting
    • Astrid Lindgrens Barnsjukhus- Radiology department
• United States
  • California
    • Indian Wells, California, United States, 92210
      • Recruiting
      • Halo Diagnostics
  • Missouri
    • Kansas City, Missouri, United States, 64108-9898
      • Recruiting
      • Children's Mercy Hospital & Clinics
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Not yet recruiting
      • Cincinnati Children's Hospital and Medical Center
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Not yet recruiting
      • Penn State Milton S. Hershey Medical Center
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Recruiting
      • Medical University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Participants from birth to <18 years of age at the time of signing the informed consent form.
• Participants who have a clinical indication to undergo a CE-MRI for any clinical condition in any body region and who can undergo study procedures as per Investigator judgement.
• Participants can be male or female (according to their reproductive organs and functions assigned by chromosomal complement).
• Female contraception and barriers as well as pregnancy testing is required as appropriate for the age and sexual activity of pediatric participants and as required by local regulations.
• The legal guardian(s) is capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
• When applicable by law for a participant, a legal guardian must be available to help the study-site personnel ensure follow up, accompany the participant to the study site on each assessment day, and consistently and consecutively be available to provide information on the participant during the scheduled study visits.

Exclusion Criteria:

• Body weight <2500 g at screening and baseline
• The medical condition and/or local allowance for maximum blood draw in the pediatric participant is not suitable for study procedures, including pharmacokinetics (PK) and safety blood draws, without compromising any expected clinical care/procedure need.
• Acute kidney injury (i.e., acute renal failure).
• Age-adjusted renal function is "decreased" (eGFR <80% of age adjusted normal renal function) as evaluated by the investigator based on a serum or plasma creatinine result obtained within 2 weeks prior to study intervention.
• Considered clinically unstable or has a concurrent/concomitant condition that may not allow participation for the full planned study period, in the judgement of the investigator.
• History of moderate to severe allergic-like reaction to any GBCA.
• Bronchial asthma considered unstable or had major therapeutical modification within last 4 weeks.
• Severe cardiovascular disease, except for cardiac or vascular magnetic resonance (MR), if considered clinically justified by the investigator.
• Planned or expected intervention (e.g., treatment or procedure) or change in treatment (e.g. start of chemotherapy) that may significantly affect study parameters (i.e. safety/adverse events [AEs] [e.g. confounding AEs or safety events due to surgery or chemotherapy], PK parameters) or would prevent the participant from performing study procedures, from the administration of gadoquatrane up to the 24 h ± 4 h follow-up.
• Participants who received or will receive any other contrast agent within 72 hours prior to gadoquatrane injection or up to 72 hours after gadoquatrane injection.
• Contraindications to the administration of GBCAs (depending on local product label), or history of adverse reaction to GBCAs.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Gadoquatrane; Participants will receive one intravenous injection of gadoquatrane during MRI.	Drug: Gadoquatrane (BAY1747846); 0.04 mmol Gd/kg body weight, solution for intravenous injection, single dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Area under the curve (AUC) of gadoquatrane after single administration	Up to 8 hours post injection
Plasma clearance normalized to body weight (CL/BW) of gadoquatrane after single administration	Up to 8 hours post injection
Apparent volume of distribution at steady state normalized to body weight (Vss/BW) of BAY1747846 after single administration	Up to 8 hours post injection
Simulation of plasma concentration at 20 min post-injection (C20)	At 20 minutes post injection

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of participants with treatment emergent adverse events, including serious adverse events	Within 24 (± 4) hours post injection
Number of participants with treatment emergent adverse events, including serious adverse events, per intensity	Within 24 (± 4) hours post injection
Number of participants with post-treatment adverse events, including serious adverse events	Up to 7 (± 1) days after the day of study intervention
Number of participants with post-treatment adverse events, including serious adverse events, per intensity	Up to 7 (± 1) days after the day of study intervention

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

Helpful Links

• Click here to find information for studies related to Bayer products. To find this study enter the ClinicalTrials.gov identifier (NCT) number or Bayer Study Identifier (ID) in the search field.

Study record dates

Study Major Dates

• Study Start (Actual): August 16, 2023
• Primary Completion (Estimated): October 16, 2024
• Study Completion (Estimated): October 23, 2024

Study Registration Dates

• First Submitted: June 14, 2023
• First Submitted That Met QC Criteria: June 14, 2023
• First Posted (Actual): June 22, 2023

Study Record Updates

• Last Update Posted (Actual): April 4, 2024
• Last Update Submitted That Met QC Criteria: April 3, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 21196; 2022-501883-17-00 (Other Identifier: CTIS (EU))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No