Comparing two MRI contrast agents for liver lesions
MR Image Quality and Liver Lesion Detection With Gadopiclenol: Comparison With Gadoxetate Disodium
This study is testing if a new MRI contrast agent called gadopiclenol works just as well as the current one, gadoxetate, for spotting liver lesions in adults with liver disease or tumors.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 75 (estimated) |
| Ages | 18 Years to 89 Years |
| Sex | All |
| Sponsor | Icahn School of Medicine at Mount Sinai Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT06596616 on ClinicalTrials.gov |
What this trial studies
This study aims to determine if gadopiclenol MRI is as effective as gadoxetate MRI in detecting liver lesions and providing high-quality images. It will involve a prospective evaluation of 75 adult patients who require MRI for chronic liver disease or tumor follow-up. The study will assess the image quality and lesion conspicuity using gadopiclenol, a new contrast agent, and compare it to the established gadoxetate. The goal is to establish noninferiority in performance while potentially using a lower dose of gadolinium.
Who should consider this trial
Good fit: Ideal candidates include adults with clinical indications for MRI related to chronic liver disease or focal lesions.
Not a fit: Patients with acute or severe chronic renal insufficiency, those under 18, or individuals with contraindications for MRI will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved MRI imaging techniques for liver lesions, enhancing diagnosis and treatment monitoring.
How similar studies have performed: While there are no prior studies directly comparing gadopiclenol with gadoxetate in abdominal imaging, gadopiclenol has shown promise in other contexts without safety concerns.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: • Adult patients of both genders and all ethnic groups with clinical indication of MRI for chronic liver disease and/or focal lesion and/or tumor treatment follow-up. Exclusion criteria: * Acute renal insufficiency. * Severe chronic renal insufficiency (GFR \<30 mL/min/1.73 m2). * Age \<18y. * Unable or unwilling to give informed consent. * Contraindications for MRI (such as pacemakers, infusion pumps, pregnancy, allergy or previous adverse reactions to gadolinium contrast agents, severe claustrophobia).
Where this trial is running
New York, New York
- Bmeii — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Sara Lewis, MD — Icahn School of Medicine at Mount Sinai
- Study coordinator: Katherine Wang, MA
- Email: katherine.wang2@mssm.edu
- Phone: 212-824-8476
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.