What side effects are associated with this type of intervention?

Gadolinium-based contrast agents (GBCAs), used for enhanced MRI imaging, commonly cause mild side effects such as headache, nausea, dizziness, and localized pain at the injection site. Rare but serious side effects include allergic reactions, nephrogenic systemic fibrosis (NSF) in patients with severe kidney dysfunction, and gadolinium retention in the brain and other tissues. Overall, GBCAs are considered safe for most patients.

What prior FDA approvals exist?

Gadolinium-based contrast agents (GBCAs) have been widely used and approved by the FDA for enhancing magnetic resonance imaging (MRI). Commonly used GBCAs include gadopentetate dimeglumine, gadobenate dimeglumine, and gadobutrol. These agents help improve the clarity and detail of MRI scans by altering the magnetic properties of nearby water molecules, thus enhancing the contrast of the images. Gadoquatrane, a new GBCA under study, aims to achieve similar or better imaging results with a lower amount of gadolinium, potentially reducing the risk of adverse effects associated with gadolinium exposure.

What other types of research exist?

One promising alternative to Gadoquatrane is EP-2104R, a fibrin-targeted, high relaxivity gadolinium tetramer. It has shown significant contrast enhancement in studies involving brain glioma models. Another alternative is gadobenate dimeglumine (Gd-BOPTA), which has demonstrated effective contrast enhancement at higher magnetic field strengths (3 Tesla) compared to standard gadolinium chelates like gadopentetate dimeglumine (Gd-DTPA). These agents may offer improved diagnostic capabilities and safety profiles for MRI contrast enhancement.

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Gadoquatrane-enhanced MRI for Body Imaging (Quanti OBR Trial)

Phase 3

Waitlist Available

Research Sponsored by Bayer

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 24 ± 4 hours after administration of gadoquatrane or any approved macrocyclic gbcas

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial is testing a new substance for MRI scans to help people with various health issues (except brain or spinal cord problems) by providing clearer images. Participants will undergo two MRI scans to compare the new substance with the current one.

Who is the study for?

Adults needing a contrast-enhanced MRI for non-brain or spinal issues can join. They must be able to have two MRIs with different contrast agents and meet specific health criteria, like stable kidney function and no severe allergies to gadolinium-based agents. Women participating should not be pregnant or breastfeeding and must use contraception if of childbearing potential.

What is being tested?

The trial is testing Gadoquatrane, a new MRI contrast agent that uses less gadolinium, against standard agents in patients with suspected body problems (excluding the central nervous system). Participants will receive both Gadoquatrane and a current agent in separate MRIs to compare effectiveness.

What are the potential side effects?

Potential side effects may include allergic reactions similar to other gadolinium-based contrasts such as skin rash, itching, headache, nausea, dizziness or feeling hot. Unstable asthma patients are excluded due to increased risk of reaction.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 24 ± 4 hours after administration of gadoquatrane or any approved macrocyclic gbcas

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within 24 ± 4 hours after administration of gadoquatrane or any approved macrocyclic gbcas

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 24 ± 4 hours after administration of gadoquatrane or any approved macrocyclic gbcas for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Visualization parameter contrast Enhancement assessed by separate blinded evaluation of unenhanced and combined pre- and post-gadoquatrane MRI, by a BICR

Visualization parameter delineation assessed by separate blinded evaluation of unenhanced and combined pre- and post-gadoquatrane MRI, by a BICR

Visualization parameter morphology assessed by separate blinded evaluation of unenhanced and combined pre- and post-gadoquatrane MRI, by a BICR

Secondary study objectives

Confidence in diagnosis combined pre- and post- gadoquatrane MRI and combined pre- and post-comparator MRI with macrocyclic GBCAs by BICR and by Investigator

Diagnoses from combined pre- and post- gadoquatrane MRI and combined pre- and post-comparator MRI with macrocyclic GBCAs by the Investigator

Number of enhancing lesions seen on combined pre- and post- gadoquatrane MRI and combined pre- and post-comparator MRI with macrocyclic GBCAs, by a BICR

+11 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Gadoquatrane - Approved Macrocyclic GBCAExperimental Treatment4 Interventions

Participants will receive one intravenous injection of gadoquatrane during MRI in Period 1, followed by one intravenous injection of any approved macrocyclic GBCA during MRI in Period 2.

Group II: Approved Macrocyclic GBCA - GadoquatraneExperimental Treatment4 Interventions

Participants will receive one intravenous injection of any approved macrocyclic GBCA during MRI in Period 1, followed by one intravenous injection of gadoquatrane during MRI in Period 2.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Gadoquatrane (BAY1747846)

2023

Completed Phase 3

~860

Gadobutrol

2020

Completed Phase 3

~960

Gadoterate meglumine

2023

Completed Phase 3

~710

Gadoteridol

2023

Completed Phase 3

~750

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Gadolinium-based contrast agents (GBCAs) like gadoquatrane work by shortening the relaxation times of protons in tissues where gadolinium accumulates, primarily affecting T1 relaxation times. This results in increased signal intensity on T1-weighted MRI images, enhancing the contrast between normal and abnormal tissues. This improved contrast is crucial for accurately detecting and evaluating various medical conditions, thereby aiding in precise diagnosis and effective treatment planning.

Investigation of the Characteristics of New, Uniform, Extremely Small Iron-Based Nanoparticles as T1 Contrast Agents for MRI.