Efficacy and Safety of Gadopiclenol for Body Magnetic Resonance Imaging (MRI)

Study Overview
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Brief Summary
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The trial aims at evaluating the efficacy and the safety of gadopiclenol for body Magnetic resonance Imaging (MRI)

Detailed Description
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The purpose of this trial is to evaluate a new gadolinium-based contrast agent (GBCA) gadopiclenol in terms of lesion visualization in patients referred for contrast-enhanced MRI of body regions. This is a prospective, international, multi-center, randomized, double-blind, controlled and cross-over trial. This trial will be conducted in approximately 50 centers worldwide. During the course of the trial, two MRIs will be obtained from each patient: one with gadopiclenol and one with gadobutrol. MRI evaluations will be assessed by independent off-site blinded readers.

Official Title
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Efficacy and Safety of Gadopiclenol for Body Magnetic Resonance Imaging (MRI)

Conditions
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Lesion in Body Region

Intervention / Treatment
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* Drug: gadopiclenol
* Drug: Gadobutrol 1 MMOLE/ML Intravenous Solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient presenting with known or suspected enhancing abnormality(ies) and/or lesion(s) in at least one body region based on a previous imaging procedure performed within 12 months prior to ICF signature. US patients are restricted to the breast in compliance with local approved indications of gadobutrol. Exclusion Criteria: Patient presenting with acute or chronic renal insufficiency, defined as an estimated Glomerular Filtration Rate (eGFR) < 30 mL/min/1.73 m² assessed within 1 day prior to each contrast agent administration.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: gadopiclenol-enhanced MRI then gadobutrol-enhanced MRI<br>Cross-over design: each patient receives gadopiclenol for the first MRI and then gadobutrol for the second MRI | Drug: gadopiclenol<br>* Single intravenous bolus injection<br>Drug: Gadobutrol 1 MMOLE/ML Intravenous Solution<br>* Single intravenous bolus injection<br>|
| Experimental: gadobutrol-enhanced MRI then gadopiclenol-enhanced MRI<br>Cross-over design: each patient receives gadobutrol for the first MRI and then gadopiclenol for the second MRI | Drug: gadopiclenol<br>* Single intravenous bolus injection<br>Drug: Gadobutrol 1 MMOLE/ML Intravenous Solution<br>* Single intravenous bolus injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lesion visualization criteria for gadopiclenol-enhanced MRI compared to unenhanced MRI | The lesion visualization criteria is based on 3 co-primary criteria: border delineation, internal morphology and degree of contrast enhancement, assessed by independent blinded readers on the images acquired during the MRI performed with gadopiclenol for up to 3 most representative lesions | 1 day procedure | 
| Lesion visualization criteria for gadopiclenol-enhanced MRI compared to gadobutrol-enhanced MRI | The lesion visualization criteria is based on 3 co-primary criteria: border delineation, internal morphology and degree of contrast enhancement, assessed by independent blinded readers on the images acquired during the MRI performed with gadopiclenol and MRI performed with gadobutrol for up to 3 most representative lesions | 1 day procedure |