check_circleStudy Completed

Contrast enhancement in magnetic resonance imaging, Children

Bayer Identifier:

21196

ClinicalTrials.gov Identifier:

NCT05915026

EudraCT Number:

Not Available

EU CT Number:

2022-501883-17-00
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)

Trial purpose

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.

Key Participants Requirements

Sex

All

Age

0 - 17 Years
  • - 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.
  • - 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.

Trial summary

Enrollment Goal
93
Trial Dates
August 2023 - October 2024
Phase
Phase 3
Could I Receive a placebo
No
Products
Gadoquatrane (BAY1747846)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Instytut "Pomnik – Centrum Zdrowia Dziecka"Warszawa, 04-730, Poland
Withdrawn
Instytut Centrum Zdrowia Matki PolkiLodz, 93-338, Poland
Active, not recruiting
Medical University of South Carolina - RadiologyCharleston, 29425, United States
Completed
Beijing Children's Hospital, Capital Medical UniversityBeijing, 100045, China
Completed
The Children's Hospital Zhejiang University School of MedHangzhou, 310056, China
Not yet recruiting
West China Second University HospitalChengdu, 610041, China
Recruiting
Children's Mercy Hospital & ClinicsKansas City, 64108-9898, United States
Completed
Halo DiagnosticsIndian Wells, 92210, United States
Completed
Centro de Diagnostico Enrique Rossi | Departamento de Investigacion ClínicaCiudad Autonoma de Buenos Aire, C1425BEE, Argentina
Completed
Sanatorio Allende | Departamento de Investigación ClínicaCórdoba, X5000JHQ, Argentina
Completed
Clinica Universitaria Reina Fabiola | Consultorios ExternosCordoba, X5004FHP, Argentina
Withdrawn
UZ Brussel - PediatrieBrussel, 1090, Belgium
Not yet recruiting
Cincinnati Children's Hospital Medical Center | Division of Nephrology and HypertensionCincinnati, 45229, United States
Not yet recruiting
Penn State Milton S. Hershey Medical CenterHershey, 17033, United States
Not yet recruiting
Hokkaido University HospitalSapporo, 060-8648, Japan
Completed
Jichi Medical University HospitalShimotsuke, 329-0498, Japan
Not yet recruiting
The University of Tokyo HospitalBunkyo-ku, 113-8655, Japan
Completed
Juntendo University HospitalBunkyo, 113-8431, Japan
Completed
National Center for Child Health and DevelopmentSetagaya-ku, 157-8535, Japan
Completed
National Hospital Organization Nagoya Medical CenterNagoya, 460-0001, Japan
Completed
Kanagawa Children's Medical CenterYokohama, 252-8555, Japan
Completed
Tokai University HospitalIsehara, 259-1193, Japan
Completed
Tokyo Metropolitan Hospital Organization Tokyo Metropolitan Children's Medical CenterFuchu, 183-8561, Japan
Completed
Japanese Red Cross Aichi Medical Center Nagoya Daiichi HospitalNagoya, 453-8511, Japan
Completed
Shizuoka Children's HospitalShizuoka, 420-8660, Japan
Withdrawn
Universitätsklinikum Carl Gustav Carus an der TU Dresden - Diagnostische und Interventionelle Radiologie / KinderradiologieDresden, 01307, Germany
Completed
Universitätsklinikum Leipzig - Institut für KinderradiologieLeipzig, 04103, Germany
Completed
Universitätsklinkum Halle (Saale) - Universitätsklinik und Poliklinik für Radiologie, KinderradiologieHalle (Saale), 06120, Germany
Completed
Universitätsklinikum Jena - Institut für Diagnostische und Interventionelle Radiologie, KinderradiologieJena, 07747, Germany
Not yet recruiting
Universitätsklinikum Münster - Klinik für Radiologie, KinderradiologieMünster, 48149, Germany
Recruiting
University Multiprofile Hospital for Active Treatment Sveti Georgi | Base II - Radiology DepartmentPlovdiv, 4000, Bulgaria
Not yet recruiting
Nara Prefecture General Medical CenterNara, 630-8581, Japan
Completed
Fakultni nemocnice Plzen - LochotinPlzen, 32300, Czech Republic
Completed
Fakultni nemocnice OstravaOstrava - Poruba, 708 52, Czech Republic
Withdrawn
Pecsi Tudomanyegyetem Klinikai Kozpont - Gyermekgyogyaszati Klinika - Onkohaematologiai OsztalyPecs, 7623, Hungary
Withdrawn
B.-A.-Z. MKK es EOK - Velkey Laszlo Gyermek Eu Kp - Gyermek Onko-haematologiai es Csontvelo Transzplantacios OsztalyMiskolc, 3526, Hungary
Withdrawn
Orszagos Mentalis, Ideggyogyaszati es Idegsebeszeti Intezet - Gyermekidegsebeszeti OsztalyBudapest, 1145, Hungary
Withdrawn
Semmelweis Egyetem - II. Sz. Gyermekgyogyaszati Klinika - Neuro-onkologiai OsztalyBudapest, 1094, Hungary
Completed
Astrid Lindgrens Barnsjukhus- Radiology departmentSolna, 17164, Sweden
Not yet recruiting
University Hospital for Active Treatment Tsaritsa Joanna - ISUL | Radiology DepartmentSofia, 1784, Bulgaria
Not yet recruiting
University Multiprofile Hospital for Active Treatment St. Ivan Rilski | Radiology DepartmentSofia, 1431, Bulgaria
Recruiting
Multiprofile Hospital for Active Treatment Central Onco Hospital | Independent Medical Diagnostic Laboratory MediscanPlovdiv, 4002, Bulgaria
Completed
The Hospital for Sick Children (SickKids)Toronto, M5G 1X8, Canada
Completed
Zhujiang Hospital of Southern Medical UniversityMISSING, 510280, China
Completed
Charité - Universitätsmedizin Berlin, Campus Virchow-Klinikum, Pädiatrische RadiologieBerlin, 13353, Germany
Withdrawn
Fondazione IRCCS Ca' Granda Ospedale Maggiore PoliclinicoMilano, 20122, Italy
Withdrawn
Ospedale Pediatrico Bambino GesùRoma, 00165, Italy
Withdrawn
IRCCS Istituto Giannina GasliniGenova, 16147, Italy

Primary Outcome

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

Secondary Outcome

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

Trial design

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)
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Basic Science
Allocation
N/A
Blinding
N/A
Assignment
Single Group Assignment
Trial Arms
1

Additional Information

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