Study Comparing Gadoquatrane with Gadoteric Acid, Gadoteridol, and Gadobutrol for MRI in Patients with Non-CNS Conditions

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What is this study about?

This clinical trial is focused on evaluating the effects and safety of a new contrast agent called gadoquatrane for use in MRI (Magnetic Resonance Imaging) tests. The study is designed for adults who have known or suspected health issues in any part of the body, except for the brain or spinal cord. The purpose of the study is to compare gadoquatrane with other already approved contrast agents, specifically gadoteric acid, gadoteridol, and gadobutrol, which are commonly used in MRI procedures.

Participants in the study will undergo two MRI scans. One scan will use the new contrast agent, gadoquatrane, and the other will use one of the approved contrast agents. The contrast agents are substances that help improve the clarity of the images produced by the MRI, making it easier for doctors to see and assess any abnormalities. The study aims to determine if gadoquatrane is as effective and safe as the other contrast agents currently in use.

The study will involve a series of MRI scans to assess the effectiveness of the contrast agents in enhancing the images. The results will help determine if gadoquatrane can be a reliable alternative to the existing contrast agents. Participants will be monitored for any side effects or adverse reactions during the study period, which will last for a short duration. The findings from this study could potentially lead to improved imaging options for patients undergoing MRI scans for various health conditions.

1 joining the study

Upon joining the study, you will be required to sign an informed consent form. This form confirms your understanding of the study and your agreement to participate.

You must be at least 18 years old and have a medical reason for needing a contrast-enhanced MRI, excluding issues related to the brain or spinal cord.

2 first MRI examination

You will undergo the first MRI examination. During this procedure, a contrast agent will be administered through an intravenous injection. This agent helps to improve the clarity of the MRI images.

The contrast agent used in this examination will be one of the approved macrocyclic gadolinium-based contrast agents (GBCAs), such as gadobutrol, gadoteric acid, or gadoteridol.

3 second MRI examination

A second MRI examination will be conducted. This time, the contrast agent gadoquatrane will be used. It will also be administered through an intravenous injection.

The purpose of using different contrast agents is to compare their effectiveness and safety in enhancing MRI images.

4 evaluation of MRI results

The MRI images from both examinations will be evaluated by a team of experts. They will assess the quality of the images and the effectiveness of the contrast agents in highlighting any abnormalities.

The evaluation will focus on several visualization parameters, including enhancement, delineation, and morphology of the images.

5 monitoring for side effects

After each MRI examination, you will be monitored for any side effects or adverse reactions to the contrast agents. This monitoring period will last for approximately 24 hours after the injection.

It is important to report any unusual symptoms or discomfort experienced during this time.

6 completion of the study

Once all procedures and evaluations are completed, your participation in the study will conclude.

The information gathered from your participation will contribute to understanding the effectiveness and safety of the contrast agents used in MRI examinations.

Who Can Join the Study?

Participant must be 18 years of age or older at the time of signing the informed consent form.
Participants must have a clinical reason to undergo a contrast-enhanced MRI (Magnetic Resonance Imaging), which is a type of scan that uses a special dye to make certain areas of the body more visible.
The MRI should be for any body region except the central nervous system, such as the head and neck, chest, abdomen, pelvis, or limbs.
Participants must be able to undergo study-related procedures, including two contrast-enhanced MRI exams: one with the study drug (gadoquatrane) and one with a standard drug (macrocyclic GBCA).
Female participants must follow local guidelines for contraception during the study. They must not be pregnant or breastfeeding. They should either be a woman of nonchildbearing potential (cannot become pregnant) or a woman of childbearing potential (can become pregnant) using an acceptable method of birth control during the study and for at least 24 hours after the last dose of the study drug.

Who Cannot Join the Study?

Patients who are allergic to gadoquatrane or any similar substances cannot participate. Gadoquatrane is a type of contrast agent used in MRI scans.
Patients with severe kidney problems are excluded. This is because the kidneys help remove the contrast agent from the body.
Pregnant women cannot participate, as the effects of the contrast agent on unborn babies are not fully known.
Patients with certain heart conditions may not be eligible, as the contrast agent can affect heart function.
Patients who have had a recent MRI with a different contrast agent may need to wait before joining the study.
Children under the age of 2 are not eligible to participate in this study.
Patients who are unable to undergo an MRI scan for any reason cannot participate. An MRI is a type of scan that uses magnets and radio waves to create images of the inside of the body.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Universitaetsmedizin Goettingen	Goettingen	Germany
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Acibadem City Clinic Diagnostic And Consultation Center Tokuda EAD	Sofia	Bulgaria
Nemocnice Pardubickeho kraje a.s.	Pardubice	Czechia

Other Sites

Site Name	City	Country
University Multiprofile Hospital For Active Treatment Saint Georgi EAD	Plovdiv	Bulgaria
Fakultni Nemocnice Plzen	Plzen	Czechia
Fakultni Nemocnice Brno	Brno	Czechia
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
University Of Debrecen	Debrecen	Hungary
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD	Sofia	Bulgaria
Kistarcsai Flor Ferenc Korhaz	Kistarcsa	Hungary
Diagnostic-consultative center “Aleksandrovska” EOOD	Sofia	Bulgaria
Assistance Publique Hopitaux De Paris	Paris	France
Ospedale San Raffaele S.r.l.	Milan	Italy
Karolinska University Hospital	Solna	Sweden
Rheinische Friedrich-Wilhelms-Universitaet Bonn	Bonn	Germany
Medical Center – University Of Freiburg	Freiburg Im Breisgau	Germany
Hospices Civils De Lyon	Lyon	France
Vseobecna Fakultni Nemocnice V Praze	Prague	Czechia
Azienda Ospedaliero-Universitaria Sant Andre	Rome	Italy
Azienda Unita’ Locale Socio Sanitaria N. 2 Marca Trevigiana	Treviso	Italy
Universitaetsklinikum Aachen AöR	Aachen	Germany
HELIOS Klinikum Berlin-Buch GmbH	Berlin	Germany
Universita Degli Studi Di Brescia	Brescia	Italy
Herzzentrum Leipzig GmbH	Leipzig	Germany
Centrum Medyczne Hcp Sp. z o.o.	Poznan	Poland
Centra Medyczne Medyceusz Sp. z o.o.	Lodz	Poland
Trial Pharma Kft.	Szeged	Hungary
Fakultni Thomayerova nemocnice	Prague	Czechia
University Hospital Ostrava	Ostrava	Czechia
Clwasu Hzyekhsfaru Uarpwpovfmqas Dm Dasza	Dijon	France
Nlykhttlauog Znndag Ofjmuf Zgmlrsbubj Kdehjwm	Bialystok	Poland
Ujffntfxui Mjbmgdajowun Hovshyey fwq Aqpctm Tifdrtsqo Sbjsj Mmztuo &ypztsp Pksvgb	Pleven	Bulgaria
Uocahnk Uxwhvtklhx Hlbmjysa	Uppsala	Sweden
Udeznqjoumhbkr Csrueul Kndklaskc	Gdansk	Poland
Ubklwcwjldhwtvvzbyrqx Eihkh Aaq	Essen	Germany
Crxjav Huviuhawczs Reyctrof Dwsjetuzoqchpk	Angers	France

Trial status

Country	Status	Recruitment Start
Bulgaria	Not recruiting	28.08.2023
Czechia	Not recruiting	28.08.2023
France	Not recruiting	28.08.2023
Germany	Not recruiting	28.08.2023
Hungary	Not recruiting	28.08.2023
Italy	Not recruiting	28.08.2023
Poland	Not recruiting	28.08.2023
Sweden	Not recruiting	28.08.2023

Trial locations

Investigated drugs:

Gadoquatrane is a new type of contrast agent used in MRI scans. It helps doctors see the inside of your body more clearly by making certain areas stand out in the images. This is especially useful for identifying any problems or diseases in different parts of the body, except the brain and spinal cord. In this study, gadoquatrane is being tested to see if it works as well as other similar contrast agents that are already approved for use.

Macrocyclic Gadolinium-Based Contrast Agents (GBCAs) are a group of contrast agents commonly used in MRI scans. They contain a substance called gadolinium, which helps to improve the quality of the images taken during the scan. These agents are already approved and widely used to help doctors diagnose various conditions by providing clearer images of the body’s internal structures. In this study, they are being used as a comparison to see if the new agent, gadoquatrane, is just as effective.

Investigated diseases:

Magnetic resonance imaging

Non-central nervous system pathology – This term refers to diseases or abnormalities that occur outside the central nervous system, which includes the brain and spinal cord. These pathologies can affect various organs and tissues in the body, such as the liver, kidneys, or muscles. The progression of these conditions varies widely depending on the specific disease or abnormality. Some may involve the growth of lesions or tumors, while others might include inflammation or degeneration of tissues. The impact on the body can range from mild to severe, influencing the function of the affected organ or system. Monitoring and assessment often involve imaging techniques to evaluate changes over time.

Trial ID:

2022-501885-24-00

Protocol code:

21197

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study Comparing Gadoquatrane with Gadoteric Acid, Gadoteridol, and Gadobutrol for MRI in Patients with Non-CNS Conditions

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?