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)

Children Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05915026
• Other study ID #: 21196
• Secondary ID: 2022-501883-17-0
• Status: Recruiting
• Phase: Phase 3
• Start date: August 16, 2023
• Est. completion date: October 23, 2024

Study information

• Verified date: June 2024
• Source: Bayer
• Contact: Bayer Clinical Trials Contact
• Phone: (+)1-888-84 22937
• Email: clinical-trials-contact[@]bayer.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 23, 2024
• Est. primary completion date: October 16, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Children

Intervention

Drug:
• Gadoquatrane (BAY1747846)
0.04 mmol Gd/kg body weight, solution for intravenous injection, single dose

Locations

Country	Name	City	State
Argentina	Centro de Diagnóstico Dr. Enrique Rossi	Buenos Aires	Ciudad Auton. De Buenos Aires
Argentina	Clinica Universitaria Reina Fabiola | Consultorios Externos	Cordoba	Córdoba
Argentina	Sanatorio Allende | Departamento de Investigación Clínica	Córdoba
Belgium	UZ Brussel - Pediatrie	Brussel
Bulgaria	Multiprofile Hospital for Active Treatment Central Onco Hospital | Independent Medical Diagnostic Laboratory Mediscan	Plovdiv
Bulgaria	University Multiprofile Hospital for Active Treatment Sveti Georgi | Base II - Radiology Department	Plovdiv
Bulgaria	University Hospital for Active Treatment Tsaritsa Joanna - ISUL | Radiology Department	Sofia
Bulgaria	University Multiprofile Hospital for Active Treatment St. Ivan Rilski | Radiology Department	Sofia
Canada	The Hospital for Sick Children (SickKids)	Toronto	Ontario
China	Beijing Children's Hospital, Capital Medical University	Beijing
China	West China Second University Hospital	Chengdu	Sichuan
China	Zhujiang Hospital of Southern Medical University	Guangzhou	Guangdong
China	The Children's Hospital Zhejiang University School of Med	Hangzhou	Zhejiang
Czechia	Fakultni nemocnice Ostrava	Ostrava
Czechia	Fakultni nemocnice Plzen - Lochotin	Plzen
Germany	Charité - Universitätsmedizin Berlin, Campus Virchow-Klinikum, Pädiatrische Radiologie	Berlin
Germany	Universitätsklinikum Carl Gustav Carus an der TU Dresden - Diagnostische und Interventionelle Radiologie / Kinderradiologie	Dresden	Sachsen
Germany	Universitätsklinkum Halle (Saale) - Universitätsklinik und Poliklinik für Radiologie, Kinderradiologie	Halle (Saale)	Sachsen-Anhalt
Germany	Universitätsklinikum Jena - Institut für Diagnostische und Interventionelle Radiologie, Kinderradiologie	Jena	Thüringen
Germany	Universitätsklinikum Leipzig - Institut für Kinderradiologie	Leipzig	Sachsen
Germany	Universitätsklinikum Münster - Klinik für Radiologie, Kinderradiologie	Münster	Nordrhein-Westfalen
Hungary	Orszagos Mentalis, Ideggyogyaszati es Idegsebeszeti Intezet - Gyermekidegsebeszeti Osztaly	Budapest
Hungary	Semmelweis Egyetem - II. Sz. Gyermekgyogyaszati Klinika - Neuro-onkologiai Osztaly	Budapest
Hungary	B.-A.-Z. MKK es EOK - Velkey Laszlo Gyermek Eu Kp - Gyermek Onko-haematologiai es Csontvelo Transzplantacios Osztaly	Miskolc
Hungary	Pecsi Tudomanyegyetem Klinikai Kozpont - Gyermekgyogyaszati Klinika - Onkohaematologiai Osztaly	Pecs
Italy	IRCCS Istituto Giannina Gaslini	Genova	Liguria
Italy	Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico	Milano	Lombardia
Italy	IRCCS Ospedale Pediatrico Bambino Gesù	Roma	Lazio
Japan	Juntendo University Hospital	Bunkyo-ku	Tokyo
Japan	The University of Tokyo Hospital	Bunkyo-ku	Tokyo
Japan	Tokyo Metropolitan Hospital Organization Tokyo Metropolitan Children's Medical Center	Fuchu	Tokyo
Japan	Tokai University Hospital	Isehara	Kanagawa
Japan	Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital	Nagoya	Aichi
Japan	National Hospital Organization Nagoya Medical Center	Nagoya	Aichi
Japan	Nara Prefecture General Medical Center	Nara
Japan	Hokkaido University Hospital	Sapporo	Hokkaido
Japan	National Center for Child Health and Development	Setagaya-ku	Tokyo
Japan	Jichi Medical University Hospital	Shimotsuke	Tochigi
Japan	Shizuoka Children's Hospital	Shizuoka
Japan	Kanagawa Children's Medical Center	Yokohama	Kanagawa
Poland	Instytut Centrum Zdrowia Matki Polki	Lodz
Poland	Instytut "Pomnik - Centrum Zdrowia Dziecka"	Warszawa
Sweden	Astrid Lindgrens Barnsjukhus- Radiology department	Solna
United States	Medical University of South Carolina | MUSC Center for Womens Health - Department of Obstetrics and Gynecology	Charleston	South Carolina
United States	Cincinnati Children's Hospital and Medical Center	Cincinnati	Ohio
United States	Penn State Milton S. Hershey Medical Center	Hershey	Pennsylvania
United States	Halo Diagnostics	Indian Wells	California
United States	Children's Mercy Hospital & Clinics	Kansas City	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

United States,  Argentina,  Belgium,  Bulgaria,  Canada,  China,  Czechia,  Germany,  Hungary,  Italy,  Japan,  Poland,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the curve (AUC) of gadoquatrane after single administration		Up to 8 hours post injection
Primary	Plasma clearance normalized to body weight (CL/BW) of gadoquatrane after single administration		Up to 8 hours post injection
Primary	Apparent volume of distribution at steady state normalized to body weight (Vss/BW) of BAY1747846 after single administration		Up to 8 hours post injection
Primary	Simulation of plasma concentration at 20 min post-injection (C20)		At 20 minutes post injection
Secondary	Number of participants with treatment emergent adverse events, including serious adverse events		Within 24 (± 4) hours post injection
Secondary	Number of participants with treatment emergent adverse events, including serious adverse events, per intensity		Within 24 (± 4) hours post injection
Secondary	Number of participants with post-treatment adverse events, including serious adverse events		Up to 7 (± 1) days after the day of study intervention
Secondary	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

External Links

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