Gadoquatrane-enhanced MRI for Body Imaging

(Quanti OBR Trial)

No longer recruiting at 153 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new MRI contrast agent called gadoquatrane to determine if it outperforms regular MRI scans without contrast. It aims to detect known or suspected issues in various body parts, such as the abdomen or chest, but excludes the brain and spinal cord. Participants will undergo two MRI scans: one with gadoquatrane and another with a different, approved contrast agent. This trial suits adults needing a contrast-enhanced MRI for issues outside the brain or spinal cord, who have not experienced severe kidney problems or recent contrast injections. As a Phase 3 trial, it represents the final step before potential FDA approval, allowing participants to contribute to the development of a new diagnostic tool.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that gadoquatrane is generally safe for humans. Studies have found that people tolerate gadoquatrane well at all tested doses, and its safety profile is similar to other common MRI contrast agents, indicating that serious side effects are rare. The body's handling of gadoquatrane resembles that of other approved contrast agents, further supporting its safety.

In studies involving both adults and children, the safety results were positive, with no unusual or unexpected issues. While some individuals might experience mild side effects, as with any medical treatment, the data so far supports gadoquatrane's safety for use in MRI scans. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about gadoquatrane-enhanced MRI because it introduces a new contrast agent, gadoquatrane, which has the potential to improve the quality of body imaging. Unlike standard macrocyclic gadolinium-based contrast agents (GBCAs), gadoquatrane may offer better image clarity and safety. This could lead to more accurate diagnoses and fewer side effects, making MRI scans more effective for patients.

What evidence suggests that this trial's treatments could be effective for body imaging?

This trial will compare gadoquatrane, a new MRI contrast agent, with approved macrocyclic GBCAs. Research has shown that gadoquatrane delivers promising results, helping doctors see body areas more clearly during scans and meeting key goals in studies. It can detect problems in the body as well as, or even better than, other approved contrast agents. Gadoquatrane uses less gadolinium, which might enhance safety while still providing clear images. Early findings also show it is stable and effective, making it a promising option for enhanced MRI scans. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

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]

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]

Citations

1. bayer2019tf.q4web.com bayer2019tf.q4web.com/news/news-details/2025/Bayers-investigational-MRI-contrast-agent-gadoquatrane-meets-primary-and-main-secondary-endpoints-in-pivotal-Phase-III-studies/default.aspx

Bayer's investigational MRI contrast agent gadoquatrane ... Topline results show that gadoquatrane met the primary and main secondary efficacy endpoints of the studies assessing visualization parameters and lesion ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05915728

A Study to Compare How Well Gadoquatrane Works and ... The researchers will compare the ability to detect known or suspected problems (except brain or spinal cord-related problems) with gadoquatrane-MRI scans to ...

3. bayer.com bayer.com/media/en-us/positive-results-from-phase-iii-study-for-bayers-investigational-contrast-agent-gadoquatrane/

Positive Results: Phase III Study for Bayer's Gadoquatrane Gadoquatrane also achieved non-inferior diagnostic performance to the trial comparators based on the sensitivity and specificity for the ...

4. rsna.org rsna.org/news/2025/march/2024-chynn-award

2024 Chynn Award | RSNA For all five regions, gadoquatrane demonstrated a linear increase in relative signal enhancement with dose. The equivalent dose was less than ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35703267/

Preclinical Profile of Gadoquatrane: A Novel Tetrameric, ... Gadoquatrane is a novel, highly effective mGBCA for use in MRI. Gadoquatrane provides favorable physicochemical properties (high relaxivity and stability, ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S0928098724000605

Pharmacokinetics, safety, and tolerability of the novel ... Gadoquatrane was safe and well tolerated at all doses tested. The pharmacokinetic profile was essentially the same as that of other extracellular macrocyclic ...

7. journals.lww.com journals.lww.com/investigativeradiology/fulltext/2024/02000/pharmacokinetics,_safety,_and_tolerability_of_the.5.aspx

Pharmacokinetics, Safety, and Tolerability of the Novel... The objective of this first-in-human study was to investigate the pharmacokinetic profile, safety, and tolerability of gadoquatrane, a novel high-relaxivity Gd ...

8. bayer.com bayer.com/en/us/news-stories/gadoquatrane

Gadoquatrane New Drug Application Accepted for Review ... Gadoquatrane is Bayer's investigational extracellular macrocyclic contrast agent in clinical development for contrast enhancement in MRI.