Study on How Gadoquatrane Works and Its Safety in Children Undergoing MRI Scans

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What is this study about?

This clinical trial is focused on studying how the substance gadoquatrane behaves in the body and its safety in children who need a special type of scan called a contrast-enhanced magnetic resonance imaging (MRI). The study involves children from birth up to 18 years old who require this scan for various medical reasons. Gadoquatrane is given as a solution for injection, and it helps to improve the quality of the MRI images by enhancing the contrast.

The purpose of the study is to understand how gadoquatrane moves into, through, and out of the body after a single injection. The study will observe how the body processes this substance and will monitor any side effects that may occur. The children participating in the study will receive a single dose of gadoquatrane through an intravenous injection, which means it is injected directly into a vein.

Throughout the study, researchers will collect information on how gadoquatrane is distributed in the body and how quickly it is cleared. They will also keep track of any side effects that might happen within a week after the injection. This information will help determine the safety and effectiveness of gadoquatrane in improving MRI scans for children.

1 joining the study

Participants from birth to less than 18 years of age are eligible to join the study. A legal guardian must provide signed informed consent.

Participants must have a clinical reason to undergo a contrast-enhanced magnetic resonance imaging (CE-MRI) and be able to follow study procedures.

2 preparation for the procedure

Before the procedure, female participants may need to undergo pregnancy testing, depending on age and local regulations.

A legal guardian should accompany the participant to the study site on each assessment day.

3 administration of the medication

The medication used in the study is called BAY 1747846, which contains the active substance gadoquatrane.

Gadoquatrane is administered as a solution for injection through an intravenous route.

The dosage is a single injection of 0.04 mmol of gadoquatrane per kilogram of body weight.

4 undergoing the CE-MRI

After the injection, the participant will undergo a contrast-enhanced magnetic resonance imaging (CE-MRI) to assess how the medication moves through the body.

5 monitoring and follow-up

Participants will be monitored for any treatment-emergent adverse events (TEAEs) within 24 hours after the injection.

A follow-up period of 7 days is required to observe any additional effects or reactions.

Who Can Join the Study?

Participants must be from birth to under 18 years old at the time of signing the informed consent form.
Participants need to have a medical reason to undergo a CE-MRI (a special type of scan that uses a contrast agent to get clearer images) for any health condition in any part of the body and must be able to go through the study procedures as judged by the doctor in charge.
Participants can be either male or female.
For female participants, appropriate birth control and pregnancy testing are required based on their age and level of sexual activity, following local rules.
The legal guardian(s) must be able to provide signed informed consent, agreeing to follow the study’s requirements and restrictions.
If required by law, a legal guardian must be available to assist the study staff, accompany the participant to the study site on each assessment day, and consistently provide information about the participant during scheduled study visits.

Who Cannot Join the Study?

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
University Hospital Jena KöR	Jena	Germany
Universitaet Leipzig	Leipzig	Germany
Technische Universitaet Dresden	Dresden	Germany
Nyiro Gyula Orszagos Pszichiatriai Es Addiktologiai Intezet	Budapest	Hungary

Other Sites

Site Name	City	Country
University Multiprofile Hospital For Active Treatment Saint Georgi EAD	Plovdiv	Bulgaria
Fakultni Nemocnice Plzen	Plzen	Czechia
Instytut Pomnik Centrum Zdrowia Dziecka	Warsaw	Poland
Karolinska University Hospital	Solna	Sweden
Uniteversity Muliprofile Hospital For Active Treatment Tsaritsa Yoanna-Isul EAD	Sofia	Bulgaria
Borsod-Abauj-Zemplen Varmegyei Koezponti Korhaz Es Egyetemi Oktatokorhaz	Miskolc	Hungary
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD	Sofia	Bulgaria
University Of Pecs	Pecs	Hungary
Semmelweis University	Budapest	Hungary
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Instytut Centrum Zdrowia Matki Polki	Lodz	Poland
University Hospital Ostrava	Ostrava	Czechia
Mdgpatrthbmiravdhhfzqbxapj Halvoboxhrxutcfr	Halle (Saale)	Germany

Trial status

Country	Status	Recruitment Start
Bulgaria	Not recruiting	29.09.2023
Czechia	Not recruiting	29.09.2023
Germany	Not recruiting	29.09.2023
Hungary	Not recruiting	29.09.2023
Italy	Not yet recruiting	29.09.2023
Poland	Not recruiting	29.09.2023
Sweden	Not recruiting	29.09.2023

Trial locations

Investigated drugs:

Gadoquatrane

Gadoquatrane is a contrast agent used in magnetic resonance imaging (MRI) to help create clearer images of the body’s internal structures. In this clinical trial, it is being studied to understand how it behaves in the body (pharmacokinetics) and to ensure its safety when used in children from birth to under 18 years old. The medication is given as a single intravenous injection before the MRI scan.

Contrast Enhancement in Magnetic Resonance Imaging in Children – This is not a disease but a medical procedure used to improve the clarity of MRI images in pediatric patients. It involves the use of contrast agents, which are substances injected into the body to highlight specific areas during imaging. The contrast agent helps to differentiate between normal and abnormal tissues, making it easier to identify issues such as tumors, inflammation, or blood vessel abnormalities. The process is particularly useful in detecting and assessing conditions affecting the brain, spine, and other organs. The enhancement effect is temporary, as the contrast agent is eventually cleared from the body. This procedure is commonly used in clinical settings to aid in the diagnosis and monitoring of various medical conditions in children.

Trial ID:

2022-501883-17-00

Protocol code:

21196

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on How Gadoquatrane Works and Its Safety in Children Undergoing MRI Scans

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