Gadopiclenol vs Gadoxetate MRI for Liver Lesions

NCT06596616 | Enrolling By Invitation

• 1 other identifier: GCO 23-1475
• Study Type: observational
• Target: 23
• Locations: 1 country
• Sites: 1

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 clinically indicated liver MRI in a prospective study. The research will be utilizing MRI; with enrollment goal of 75 subjects over the course of two years.

Conditions

Liver Lesion

Outcome Measures

Primary Outcomes (1)

• Lesion Detection

  Lesion detection (for any enhancing lesions including benign and malignant lesions, excluding cysts and completely necrotic treated malignant lesions) will be evaluated both for gadopiclenol-enhanced study (including unenhanced sequences from index MRI) and gadoxetate-enhanced MRI (the reference standard method): will be classified for each post- contrast phase as 0: no visible enhancing lesion, 1: visible enhancing lesion.

  End of study, at 6 months

Secondary Outcomes (1)

• Liver lesion conspicuity

  End of study, at 6 months

Study Arms (1)

Liver

Patients who have had clinically indicated MRI scans for liver lesions.

Other: Radiology; Other: Gadopiclenol

Interventions

Radiology OTHER

Radiology - MRI Scans

Liver

Gadopiclenol OTHER

Gadopiclenol is a new macrocyclic gadolinium-based contrast agent (GBCA)

Liver

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with undergoing MRI for management of chronic liver disease, liver lesions, and/or tumor treatment follow up

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• Guerbet: collaborator

Study Sites (1)

BMEII

New York, New York, 10029, United States

Location

MeSH Terms

Interventions

X-Rays; gadopiclenol

Intervention Hierarchy (Ancestors)

Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing

Study Officials

• Sara Lewis, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 11, 2024
• First Posted: September 19, 2024
• Study Start: July 1, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)