Gadopiclenol vs Gadoxetate MRI for Liver Lesions

MR Image Quality and Liver Lesion Detection With Gadopiclenol: Comparison With Gadoxetate Disodium

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Liver Lesion
• Intervention / Treatment: Other: Radiology; Other: Gadopiclenol

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 in preclinical studies. In a rodent model of liver metastasis, gadopiclenol showed strong enhancement with comparable pharmacokinetics to other extracellular GBCAs (EC-GBCAs). It was found to have a potential of either improving lesion conspicuity or providing similar accuracy in lesion detection with a reduced Gadolinium (Gd) dose. In a rat brain tumor model, half dose (0.05 mmol/kg) of gadopiclenol yielded comparable contrast-to-noise ratio (CNR) and morphological characterization of brain tumors compared to other EC-GBCAs. There are also a few clinical studies in which no safety concern was raised with the use of gadopiclenol. No dose adjustment for children or patients with renal impairment was found to be required. There is no study in the literature assessing the enhancement properties of gadopiclenol in abdominal imaging and comparing it with a hepatobiliary agent for image quality and lesion detection/conspicuity in the liver. For this study, it is hypothesized that dynamic imaging using Gadopiclenol is noninferior to gadoxetate MRI in terms of image quality and lesion detection/conspicuity.

• Study Type: Observational
• Enrollment (Estimated): 23

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • BMEII

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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

Description

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).

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Liver; Patients who have had clinically indicated MRI scans for liver lesions.	Other: Radiology; Radiology - MRI Scans; Other: Gadopiclenol; Gadopiclenol is a new macrocyclic gadolinium-based contrast agent (GBCA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Liver lesion conspicuity	Liver lesion conspicuity (detected on full protocol clinical MRI scan) will be assessed for each postcontrast phase using the following scores: 0, not seen; 1: barely conspicuous; 2: fairly well seen; 3: moderately well seen; 4: well seen; and 5: very well seen. Each lesion will be delineated on Couinaud segmental maps.	End of study, at 6 months

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Collaborators: Guerbet
• Investigators: Principal Investigator: Sara Lewis, MD, Icahn School of Medicine at Mount Sinai

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: September 11, 2024
• First Submitted That Met QC Criteria: September 11, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): April 22, 2026
• Last Update Submitted That Met QC Criteria: April 17, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physical Phenomena; Electromagnetic Phenomena; Magnetic Phenomena; Electromagnetic Radiation; Radiation; Radiation, Ionizing; X-Rays; gadopiclenol
• Other Study ID Numbers: GCO 23-1475

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Not within the scope the study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No