Gadopiclenol vs. Gadobutrol for MRI Contrast Imaging

(MRI Trial)

Overseen By Leo Wolansky, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: UConn Health

Must not be taking: Investigational drugs, Contrast agents

Disqualifiers: Heart failure, Renal insufficiency, others

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

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

Compensation: Varies

Number of Visits: 2

Duration: 3-14 days

10 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will evaluate the efficacy and safety of Gadopiclenol, an FDA-approved contrast agent, for visualizing pituitary lesions on MR images by comparing with the comparator, Gadobutrol, a clinically widely used contrast agent. The study is double-blinded, so neither the participants nor the researchers know which contrast agent is being used during each scan to avoid the bias of results.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on corticosteroids or maintenance chemotherapy with a stable dose, you can continue these during the trial.

What data supports the effectiveness of the drug Gadopiclenol compared to Gadobutrol for MRI contrast imaging?

Research shows that Gadopiclenol, even at a lower dose, is just as effective as Gadobutrol for enhancing MRI images of the body, making it a good alternative with a similar safety profile. ^{1 2 3 4 5}

Is Gadopiclenol safe compared to Gadobutrol for MRI contrast imaging?

Both Gadopiclenol and Gadobutrol have similar safety profiles, with no significant differences in the frequency, intensity, or type of adverse events reported in clinical trials. Gadobutrol has been studied extensively, including in over 23,000 patients, showing it is generally safe for use in MRI. ^{1 2 6 7 8}

How does the drug Gadopiclenol differ from other MRI contrast agents?

Gadopiclenol is unique because it is a high-relaxivity gadolinium-based contrast agent, allowing for a lower dose to be used while maintaining similar effectiveness to standard agents like Gadobutrol. This means it can provide clear MRI images with less gadolinium, potentially reducing the risk of gadolinium retention in tissues. ^{1 2 4 9 10}

Eligibility Criteria

This trial is for adults with suspected or known pituitary lesions. Men must be 18+ years old, women 55+. Participants need health insurance, a prior imaging scan within the last year, and may have had treatment if suspicion of remaining lesions exists. They must consent to two MRIs.

Inclusion Criteria

I am willing and able to join the trial.

I am covered by national health insurance.

I am scheduled for a special MRI of my pituitary gland and agree to a second one for the study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo two MRI scans using different contrast agents (Gadopiclenol and Gadobutrol) to evaluate pituitary lesions

3-14 days

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after MRI scans

4 weeks

Treatment Details

Interventions

• Gadobutrol
• Gadopiclenol

Trial Overview The study tests Gadopiclenol against Gadobutrol for MRI contrast enhancement in visualizing pituitary lesions. It's double-blinded to ensure unbiased results between these FDA-approved agents.

Participant Groups

Group I: Gadopiclinol (brand name, Elucirem) first group Experimental Treatment 1 Intervention

Participants of Arm 1 will use Gadopiclinol (Brand name, Elucirem) contrast for the first MRI scan and use Gadobutrol (Brand name, Gadavist)contrast for the second MRI scan

Group II: Gadobutrol (Brand name, Gadavist) first group Active Control 1 Intervention

Participants of Arm 2 will use Gadobutrol contrast for the MRI scan and Gadopiclinol contrast for the second MRI scan.

Who Is Running the Clinical Trial?

UConn Health

Lead Sponsor

Trials

218

Recruited

59,100+

Findings from Research

In a phase 3 study involving 273 participants, gadopiclenol at a lower dose (0.05 mmol/kg) was found to be noninferior to gadobutrol at a higher dose (0.1 mmol/kg) for visualizing lesions in body MRI, indicating it can be an effective alternative.

Both gadopiclenol and gadobutrol showed similar safety profiles, with no significant differences in adverse events, suggesting that gadopiclenol may provide a safer option with a reduced gadolinium dose.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Half-Dose Gadopiclenol versus Full-Dose Gadobutrol for Contrast-enhanced Body MRI. Kuhl, C., Csőszi, T., Piskorski, W., et al.[2023]

References

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

Efficacy and Safety of Half-Dose Gadopiclenol versus Full-Dose Gadobutrol for Contrast-enhanced Body MRI. [2023]

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

Efficacy and Safety of Gadopiclenol for Contrast-Enhanced MRI of the Central Nervous System: The PICTURE Randomized Clinical Trial. [2023]

3. Germany pubmed.ncbi.nlm.nih.gov

Intra-individual randomised comparison of gadobutrol 1.0 M versus gadobenate dimeglumine 0.5 M in patients scheduled for preoperative breast MRI. [2021]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Correction to: Gadobutrol: A Review in Contrast-Enhanced MRI and MRA. [2019]

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

Intraindividual quantitative and qualitative comparison of gadopentetate dimeglumine and gadobutrol in time-resolved contrast-enhanced 4-dimensional magnetic resonance angiography in minipigs. [2015]

6. Japan pubmed.ncbi.nlm.nih.gov

Post-marketing surveillance of gadobutrol for contrast-enhanced magnetic resonance imaging in Japan. [2019]

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

Safety of gadobutrol in over 23,000 patients: the GARDIAN study, a global multicentre, prospective, non-interventional study. [2022]

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

Safety and efficacy of gadobutrol-enhanced MRI in patients aged under 2 years-a single-center, observational study. [2021]

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

Contrast-to-Dose Relationship of Gadopiclenol, an MRI Macrocyclic Gadolinium-based Contrast Agent, Compared with Gadoterate, Gadobenate, and Gadobutrol in a Rat Brain Tumor Model. [2020]

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

Preclinical Safety Assessment of Gadopiclenol: A High-Relaxivity Macrocyclic Gadolinium-Based MRI Contrast Agent. [2023]