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)

Sponsor

Bayer (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05915026

Collaborator

(none)

100

Enrollment

Locations

Arm

14.3

Anticipated Duration (Months)

2.3

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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). CE-MRI may allow 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 scan 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 scan.

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 like age and medical history,
take participants' blood samples,
ask participants 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.

Condition or Disease	Intervention/Treatment	Phase
Contrast Enhancement in Magnetic Resonance Imaging Children	Drug: Gadoquatrane (BAY1747846)	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

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)

Anticipated Study Start Date :

Aug 16, 2023

Anticipated Primary Completion Date :

Oct 16, 2024

Anticipated Study Completion Date :

Oct 23, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

0 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 <2,500 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 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 and/or requiring treatment.
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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Halo Diagnostics	Indian Wells	California	United States	92210
2	Children's Mercy Hospital & Clinics	Kansas City	Missouri	United States	64108-9898
3	Cincinnati Children's Hospital and Medical Center	Cincinnati	Ohio	United States	45229
4	Penn State Milton S. Hershey Medical Center	Hershey	Pennsylvania	United States	17033
5	Medical University of South Carolina	Charleston	South Carolina	United States	29425
6	Centro de Diagnóstico Dr. Enrique Rossi	Buenos Aires	Ciudad Auton. De Buenos Aires	Argentina	C1425BEE
7	Sanatorio Allende \| Departamento de Investigación Clínica	Córdoba		Argentina	X5000JHQ
8	Clínica Universitaria Reina Fabiola	Córdoba		Argentina	X5004FHP
9	UZ Brussel - Pediatrie	Brussel		Belgium	1090
10	Central Onco Hospital OOD	Plovdiv		Bulgaria	4000
11	UMHAT Sveti Georgi	Plovdiv		Bulgaria	4002
12	University Multiprofile Hosp. for Active Treat. Sveti Ivan	Sofia		Bulgaria	1431
13	UMHAT Tsaritsa Joanna-ISUL EAD Sofia	Sofia		Bulgaria	1527
14	The Hospital for Sick Children (SickKids)	Toronto	Ontario	Canada	M5G 1X8
15	Zhujiang Hospital of Southern Medical University	Guangzhou	Guangdong	China	510280
16	West China Second University Hospital	Chengdu	Sichuan	China	610066
17	The Children's Hospital Zhengjiang University School of Med.	Hangzhou	Zhejiang	China	310056
18	Beijing Children's Hospital, Capital Medical University	Beijing		China	100045
19	Fakultni nemocnice Ostrava	Ostrava		Czechia	708 52
20	Fakultni nemocnice Plzen - Lochotin	Plzen		Czechia	304 60
21	Universitätsklinikum Münster - Klinik für Radiologie, Kinderradiologie	Münster	Nordrhein-Westfalen	Germany	48149
22	Universitätsklinkum Halle (Saale) - Universitätsklinik und Poliklinik für Radiologie, Kinderradiologie	Halle (Saale)	Sachsen-Anhalt	Germany	06120
23	Universitätsklinikum Carl Gustav Carus an der TU Dresden - Diagnostische und Interventionelle Radiologie / Kinderradiologie	Dresden	Sachsen	Germany	01307
24	Universitätsklinikum Leipzig - Institut für Kinderradiologie	Leipzig	Sachsen	Germany	04103
25	Universitätsklinikum Jena - Institut für Diagnostische und Interventionelle Radiologie, Kinderradiologie	Jena	Thüringen	Germany	07747
26	Semmelweis Egyetem - II. Sz. Gyermekgyogyaszati Klinika - Neuro-onkologiai Osztaly	Budapest		Hungary	1094
27	Orszagos Mentalis, Ideggyogyaszati es Idegsebeszeti Intezet - Gyermekidegsebeszeti Osztaly	Budapest		Hungary	1145
28	B.-A.-Z. MKK es EOK - Velkey Laszlo Gyermek Eu Kp - Gyermek Onko-haematologiai es Csontvelo Transzplantacios Osztaly	Miskolc		Hungary	3526
29	Pecsi Tudomanyegyetem Klinikai Kozpont - Gyermekgyogyaszati Klinika - Onkohaematologiai Osztaly	Pecs		Hungary	7623
30	Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital	Nagoya	Aichi	Japan	453-8511
31	National Hospital Organization Nagoya Medical Center	Nagoya	Aichi	Japan	460-0001
32	Hokkaido University Hospital	Sapporo	Hokkaido	Japan	060-8648
33	Tokai University Hospital	Isehara	Kanagawa	Japan	259-1193
34	Kanagawa Children's Medical Center	Yokohama	Kanagawa	Japan	232-8555
35	Jichi Medical University Hospital	Shimotsuke	Tochigi	Japan	329-0498
36	Juntendo University Hospital	Bunkyo-ku	Tokyo	Japan	113-8431
37	The University of Tokyo Hospital	Bunkyo-ku	Tokyo	Japan	113-8655
38	Tokyo Metropolitan Hospital Organization Tokyo Metropolitan Children's Medical Center	Fuchu	Tokyo	Japan	183-8561
39	National Center for Child Health and Development	Setagaya-ku	Tokyo	Japan	157-8535
40	Nara Prefecture General Medical Center	Nara		Japan	630-8581
41	Shizuoka Children's Hospital	Shizuoka		Japan	420-8660
42	Instytut Centrum Zdrowia Matki Polki	Lodz		Poland	93-338
43	Instytut "Pomnik - Centrum Zdrowia Dziecka"	Warszawa		Poland	04-730
44	Astrid Lindgrens Barnsjukhus- Radiology department	Solna		Sweden	17164

Sponsors and Collaborators

Bayer

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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.

Publications

None provided.

Responsible Party:

Bayer

ClinicalTrials.gov Identifier:

NCT05915026

Other Study ID Numbers:

21196
2022-501883-17-00

First Posted:

Jun 22, 2023

Last Update Posted:

Jun 22, 2023

Last Verified:

Jun 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jun 22, 2023