Status:
ENROLLING_BY_INVITATION
Gadopiclenol vs Gadoxetate MRI for Liver Lesions
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Collaborating Sponsors:
Guerbet
Conditions:
Liver Lesion
Eligibility:
All Genders
18-89 years
Brief Summary
The overall purpose of this study is to establish noninferiority of gadopiclenol MRI compared to gadoxetate MRI in terms of image quality and lesion detection/conspicuity in patients undergoing clinic...
Detailed Description
Gadopiclenol is a new macrocyclic gadolinium-based contrast agent (GBCA) which has higher relaxivity than other GBCAs with a potential use of lower dose and comparable pharmacokinetics to other agents...
Eligibility Criteria
Inclusion
- 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).
Exclusion
Key Trial Info
Start Date :
July 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 27 2026
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT06596616
Start Date
July 1 2024
End Date
March 27 2026
Last Update
July 29 2025
Active Locations (1)
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1
BMEII
New York, New York, United States, 10029