Gadopiclenol vs. Gadobutrol for MRI Contrast Imaging
(MRI Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to evaluate the effectiveness of Gadopiclenol, a contrast agent, in enhancing the visibility of pituitary lesions on MRI scans compared to Gadobutrol, a commonly used contrast agent. Both agents undergo testing to ensure accuracy and safety, with participants receiving each one during separate MRI scans. The trial is double-blinded, meaning neither participants nor researchers know which contrast agent is used during each scan, ensuring unbiased results. It seeks adults with known or suspected pituitary lesions, based on recent imaging, who are scheduled for an MRI scan focused on the pituitary gland. As a Phase 4 trial, this research involves an FDA-approved treatment and aims to understand its benefits for more patients.
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 is the safety track record for these treatments?
Research has shown that Gadopiclenol, also known as Elucirem, is a well-tolerated MRI contrast agent. Studies have demonstrated that it performs as effectively as Gadobutrol, another commonly used contrast agent. Gadopiclenol is very stable and significantly enhances MRI images.
Safety data from its first year on the market supports its positive safety profile, indicating it has been used without major safety concerns. Research indicates that Gadopiclenol is a reliable choice for MRI scans, with no significant adverse events reported.12345Why are researchers enthusiastic about this study treatment?
Researchers are excited about the use of Gadopiclenol because it offers a potentially improved contrast agent for MRI scans. Unlike Gadobutrol, which is a well-established standard in MRI contrast imaging, Gadopiclenol is being studied for its effectiveness at potentially lower doses, which could enhance patient safety by reducing the risk of side effects. Additionally, Gadopiclenol might provide clearer imaging results, which can be crucial for accurate diagnosis and treatment planning. This could be a game-changer in how we conduct MRI imaging, making it a focal point of interest for researchers.
What evidence suggests that this trial's treatments could be effective for visualizing pituitary lesions?
This trial will compare Gadopiclenol and Gadobutrol for MRI contrast imaging. Research has shown that Gadopiclenol works well for MRI scans, particularly for examining the brain and spinal cord. Studies have found that it provides images as clear as those from Gadobutrol, a commonly used contrast dye. Gadopiclenol is very stable and improves image quality more effectively than other dyes. In some cases, it has better revealed certain types of brain lesions. Overall, Gadopiclenol is a proven choice for enhancing MRI image clarity and detail. Participants in this trial will receive both Gadopiclenol and Gadobutrol in different sequences to directly compare their effectiveness.678910
Are You a Good Fit for This Trial?
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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo two MRI scans using different contrast agents (Gadopiclenol and Gadobutrol) to evaluate pituitary lesions
Follow-up
Participants are monitored for safety and effectiveness after MRI scans
What Are the Treatments Tested in This Trial?
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.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
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
Participants of Arm 2 will use Gadobutrol contrast for the MRI scan and Gadopiclinol contrast for the second MRI scan.
Find a Clinic Near You
Who Is Running the Clinical Trial?
UConn Health
Lead Sponsor
Published Research Related to This Trial
Citations
Efficacy and Safety of Gadopiclenol for Contrast-Enhanced ...
This study aimed to demonstrate that contrast-enhanced MRI of the central nervous system (CNS) with gadopiclenol at 0.05 mmol/kg is not inferior to gadobutrol ...
NCT03986138 | Efficacy and Safety of Gadopiclenol for ...
The purpose of this trial was to evaluate a new gadolinium-based contrast agent (GBCA) gadopiclenol in terms of lesion visualization in patients referred ...
Data Reinforcing Efficacy and Safety of Gadopiclenol in ...
Gadopiclenol is highly stable and shows the highest relaxivity among the gadolinium-based contrast agents available for clinical use. ii, ììì, ...
Research On New MRI Contrast Agent Wins 2022 Chynn ...
Contrast enhanced MRI with Gadopiclenol (left) better demonstrating a brain metastasis than comparator agent (right). Images courtesy of J. Hao.
Elucirem | European Medicines Agency (EMA)
All doctors considered that MRI images with Elucirem were clearer than those made without a contrast agent, and comparable with those made with ...
Elucirem - accessdata.fda.gov
ELUCIREM. •. Contrast MRI can begin immediately following the injection of ELUCIREM. 2. Reference ID: 5047757. This label may not be the latest approved by FDA ...
Efficacy and Safety of Gadopiclenol for Contrast-Enhanced ...
This study aimed to demonstrate that contrast-enhanced MRI of the central nervous system (CNS) with gadopiclenol at 0.05 mmol/kg is not inferior to gadobutrol ...
8.
ema.europa.eu
ema.europa.eu/en/documents/assessment-report/elucirem-epar-public-assessment-report_en.pdfElucirem, gadopiclenol - European Medicines Agency
contrast agent for Magnetic Resonance Imaging (MRI). ... Title: Efficacy and safety of gadopiclenol foR bOdy MagnetIc reSonancE imaging (MRI) ( ...
Data Reinforcing Efficacy and Safety of Gadopiclenol in ...
Gadopiclenol is highly stable and shows the highest relaxivity among the gadolinium-based contrast agents available for clinical use. ii, ììì, ...
10.
journals.lww.com
journals.lww.com/investigativeradiology/fulltext/2025/06000/safety_of_gadopiclenol_after_its_first_year_of.8.aspxSafety of Gadopiclenol After Its First Year of Clinical Use
Safety data from postmarketing surveillance of gadopiclenol further confirm its positive benefit-risk profile demonstrated in preapproval clinical studies. The ...
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