Gadoquatrane-enhanced MRI for Body Imaging

(Quanti OBR Trial)

Recruiting at 136 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Bayer

Must be taking: Macrocyclic GBCAs

Must not be taking: Contrast agents

Disqualifiers: Severe renal insufficiency, acute kidney injury, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 7

Duration: 1 day procedure

404 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you have severe kidney issues or are planning to undergo certain medical procedures, you may not be eligible to participate.

What data supports the effectiveness of the drug Gadoquatrane for body imaging?

Research shows that Gadoquatrane is a new type of gadolinium-based contrast agent, which is known for being safe and effective in enhancing MRI images. Gadoquatrane is designed to be more efficient, potentially allowing for lower doses while still providing clear images, which suggests it could be effective for body imaging. ^{1 2 3 4 5}

Is Gadoquatrane safe for use in humans?

Gadoquatrane, a new type of gadolinium-based contrast agent used in MRI, has been studied for safety and tolerability in healthy adults and is considered safe. Gadolinium-based agents, in general, have a good safety record, but they can have rare side effects like allergic reactions and, in people with kidney problems, a serious condition called nephrogenic systemic fibrosis (NSF). ^{1 6 7 8 9}

How is gadoquatrane different from other MRI contrast agents?

Gadoquatrane is unique because it is a new type of gadolinium-based contrast agent designed to have high relaxivity, which means it can provide clearer images at lower doses compared to traditional agents. This makes it potentially safer and more effective for MRI scans. ^{1 3 10 11 12}

Eligibility Criteria

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.

Inclusion Criteria

Contraceptive use by female participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies

I need an MRI with a specific safe contrast dye due to my condition.

I can have 2 MRI scans with contrast for this study.

Exclusion Criteria

I have severe kidney problems.

I have acute kidney injury.

I have recently had a test that required a contrast dye.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo two MRI scans, one with gadoquatrane and one with an approved macrocyclic GBCA, with intravenous injections of contrast agents

1 day procedure

2 visits (in-person)

Follow-up

Participants are monitored for adverse events and undergo evaluations including blood and urine samples, physical examinations, and vital sign checks

Within 24 ± 4 hours after administration

Up to 5 visits (in-person)

Treatment Details

Interventions

• Gadoquatrane

Trial Overview 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.

Participant Groups

Group I: Gadoquatrane - Approved Macrocyclic GBCA Experimental Treatment 4 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 - Gadoquatrane Experimental Treatment 4 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.

Who Is Running the Clinical Trial?

Bayer

Lead Sponsor

Trials

2,291

Recruited

25,560,000+

Founded

1863

Headquarters

Leverkusen, Germany

Known For

Pharmaceutical Innovations

Top Products

Aspirin, Aleve, Yaz, Nexavar

Bill Anderson

Bayer

Chief Executive Officer since 2023

BSc in Chemical Engineering from the University of Texas, MSc in Chemical Engineering and Management from MIT

Michael Devoy

Bayer

Chief Medical Officer since 2014

MD, PhD

Findings from Research

Gadolinium-based contrast agents (GBCAs) are generally very safe for use in MRI, with acute allergic reactions being rare and less common than those associated with iodinated contrast agents.

While there are concerns about gadolinium deposition in the brain and other organs, current evidence shows no adverse biological or clinical effects from this retention, especially in patients with normal kidney function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Update on Gadolinium Based Contrast Agent Safety, From the AJR Special Series on Contrast Media. Starekova, J., Pirasteh, A., Reeder, SB.[2023]

Gadolinium-based contrast agents (GBCAs) have a strong safety record in MRI imaging, but there are known risks such as acute adverse reactions and nephrogenic systemic fibrosis that require ongoing management and understanding.

The review highlights that certain populations, including those with kidney issues, are at higher risk for complications from GBCAs, and it also discusses the emerging use of ferumoxytol as a non-GBCA alternative with its own risk profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety issues related to intravenous contrast agent use in magnetic resonance imaging. Ponrartana, S., Moore, MM., Chan, SS., et al.[2021]

In a study of 28,078 patients receiving gadoteridol for MR imaging, the overall adverse reaction rate was low at 0.666%, with the majority being mild reactions, particularly nausea (0.530%).

The rate of nausea observed was significantly lower than the 1.4% reported in earlier clinical trials, suggesting that gadoteridol may have a better safety profile compared to previously used contrast agents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of adverse reaction rates during gadoteridol-enhanced MR imaging in 28,078 patients. Morgan, DE., Spann, JS., Lockhart, ME., et al.[2015]

A total of 424 risk signals related to adverse events (AEs) were identified from the FAERS database for four gadolinium-based contrast agents (GBCAs) over an 18-year period, highlighting significant safety concerns associated with these agents.

The study revealed that some adverse events linked to GBCAs were not included in their package inserts, indicating a need for further research to ensure patient safety and awareness of potential risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Data mining and analysis of the adverse events derived signals of 4 gadolinium-based contrast agents based on the US Food and drug administration adverse event reporting system. Wang, L., Wang, Y., Zhao, Q.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Pharmacokinetics, Safety, and Tolerability of the Novel Tetrameric, High-Relaxivity, Macrocyclic Gadolinium-Based Contrast Agent Gadoquatrane in Healthy Adults. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Pharmacokinetics and safety of gadobenate dimeglumine (multihance) in subjects with impaired liver function. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Preclinical Profile of Gadoquatrane: A Novel Tetrameric, Macrocyclic High Relaxivity Gadolinium-Based Contrast Agent. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Prospective comparison of image quality and diagnostic accuracy of 0.5 molar gadobenate dimeglumine and 1.0 molar gadobutrol in contrast-enhanced run-off magnetic resonance angiography of the lower extremities. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

Dynamic contrast-enhanced MR imaging of the prostate: intraindividual comparison of gadoterate meglumine and gadobutrol. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Update on Gadolinium Based Contrast Agent Safety, From the AJR Special Series on Contrast Media. [2023]

7. Germany pubmed.ncbi.nlm.nih.gov

Safety issues related to intravenous contrast agent use in magnetic resonance imaging. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Assessment of adverse reaction rates during gadoteridol-enhanced MR imaging in 28,078 patients. [2015]

9. England pubmed.ncbi.nlm.nih.gov

Data mining and analysis of the adverse events derived signals of 4 gadolinium-based contrast agents based on the US Food and drug administration adverse event reporting system. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Interstitial MR lymphography with a conventional extracellular gadolinium-based agent: assessment in rabbits. [2016]

11. United States pubmed.ncbi.nlm.nih.gov

Handling a high relaxivity contrast material for dynamic breast MR imaging using higher thresholds for the initial enhancement. [2015]

12. Germany pubmed.ncbi.nlm.nih.gov

A comparison of Gd-BOPTA and Gd-DOTA for contrast-enhanced MRI of intracranial tumours. [2018]