Clinical trial NCT05915026: 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)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Contrast Enhancement in Magnetic Resonance Imaging
Children
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2023-06-22
Enrollment: 93
Sex: ALL
Minimum age (years): 0
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Area under the curve (AUC) of gadoquatrane after single administration
timeFrame: Up to 8 hours post injection
measure: Plasma clearance normalized to body weight (CL/BW) of gadoquatrane after single administration
timeFrame: Up to 8 hours post injection
measure: Apparent volume of distribution at steady state normalized to body weight (Vss/BW) of BAY1747846 after single administration
timeFrame: Up to 8 hours post injection
measure: Simulation of plasma concentration at 20 min post-injection (C20)
timeFrame: At 20 minutes post injection
Secondary outcomes:
measure: Number of participants with treatment emergent adverse events, including serious adverse events
timeFrame: Within 24 (± 4) hours post injection
measure: Number of participants with treatment emergent adverse events, including serious adverse events, per intensity
timeFrame: Within 24 (± 4) hours post injection
measure: Number of participants with post-treatment adverse events, including serious adverse events
timeFrame: Up to 7 (± 1) days after the day of study intervention
measure: Number of participants with post-treatment adverse events, including serious adverse events, per intensity
timeFrame: Up to 7 (± 1) days after the day of study intervention
Other outcomes:
Locations:
city: Indian Wells
country: United States
facility: Halo Diagnostics
state: California
city: Kansas City
country: United States
facility: Children's Mercy Hospital & Clinics
state: Missouri
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center | Division of Nephrology and Hypertension
state: Ohio
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina - Radiology
state: South Carolina
city: Ciudad Autonoma de Buenos Aire
country: Argentina
facility: Centro de Diagnostico Enrique Rossi | Departamento de Investigacion Clínica
state: Ciudad Auton. De Buenos Aires
city: Cordoba
country: Argentina
facility: Clinica Universitaria Reina Fabiola | Consultorios Externos
city: Córdoba
country: Argentina
facility: Sanatorio Allende | Departamento de Investigación Clínica
city: Plovdiv
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatment Sveti Georgi | Base II - Radiology Department
city: Plovdiv
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment Central Onco Hospital | Independent Medical Diagnostic Laboratory Mediscan
city: Sofia
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatment St. Ivan Rilski | Radiology Department
city: Sofia
country: Bulgaria
facility: University Hospital for Active Treatment Tsaritsa Joanna - ISUL | Radiology Department
city: Toronto
country: Canada
facility: The Hospital for Sick Children (SickKids)
state: Ontario
city: Missing
country: China
facility: Zhujiang Hospital of Southern Medical University
state: Guangdong
city: Chengdu
country: China
facility: West China Second University Hospital
state: Sichuan
city: Hangzhou
country: China
facility: The Children's Hospital Zhejiang University School of Med
state: Zhejiang
city: Beijing
country: China
facility: Beijing Children's Hospital, Capital Medical University
city: Ostrava - Poruba
country: Czechia
facility: Fakultni nemocnice Ostrava
city: Plzen
country: Czechia
facility: Fakultni nemocnice Plzen - Lochotin
city: Münster
country: Germany
facility: Universitätsklinikum Münster - Klinik für Radiologie, Kinderradiologie
state: Nordrhein-Westfalen
city: Halle (Saale)
country: Germany
facility: Universitätsklinkum Halle (Saale) - Universitätsklinik und Poliklinik für Radiologie, Kinderradiologie
state: Sachsen-Anhalt
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig - Institut für Kinderradiologie
state: Sachsen
city: Jena
country: Germany
facility: Universitätsklinikum Jena - Institut für Diagnostische und Interventionelle Radiologie, Kinderradiologie
state: Thüringen
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin, Campus Virchow-Klinikum, Pädiatrische Radiologie
city: Nagoya
country: Japan
facility: Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital
state: Aichi
city: Nagoya
country: Japan
facility: National Hospital Organization Nagoya Medical Center
state: Aichi
city: Sapporo
country: Japan
facility: Hokkaido University Hospital
state: Hokkaido
city: Isehara
country: Japan
facility: Tokai University Hospital
state: Kanagawa
city: Yokohama
country: Japan
facility: Kanagawa Children's Medical Center
state: Kanagawa
city: Shimotsuke
country: Japan
facility: Jichi Medical University Hospital
state: Tochigi
city: Bunkyo-ku
country: Japan
facility: The University of Tokyo Hospital
state: Tokyo
city: Bunkyo
country: Japan
facility: Juntendo University Hospital
state: Tokyo
city: Fuchu
country: Japan
facility: Tokyo Metropolitan Hospital Organization Tokyo Metropolitan Children's Medical Center
state: Tokyo
city: Setagaya-ku
country: Japan
facility: National Center for Child Health and Development
state: Tokyo
city: Nara
country: Japan
facility: Nara Prefecture General Medical Center
city: Shizuoka
country: Japan
facility: Shizuoka Children's Hospital
city: Warszawa
country: Poland
facility: Instytut "Pomnik - Centrum Zdrowia Dziecka"
city: Solna
country: Sweden
facility: Astrid Lindgrens Barnsjukhus- Radiology department
Study officials:
References: