Efficacy and Safety of Gadopiclenol for Central Nervous System (CNS) Magnetic Resonance Imaging (MRI)

Study Overview
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Brief Summary
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the trial aims to evaluate the Efficacy and Safety of gadopiclenol for Central Nervous System (CNS) 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 injection for Central Nervous System (CNS) lesion detection and visualization by conventional steady-state CNS imaging. . This is a multi-center, international, prospective, double-blind, randomized, controlled,cross-over with comparator trial in male and female patients presenting with known or highly suspected CNS lesion(s) with focal areas of disrupted Blood Brain Barrier (BBB) (e.g., primary and secondary tumors) who are scheduled to undergo a routine contrast-enhanced Magnetic Resonance Imaging (MRI) of the CNS. This trial will be conducted in approximately 40 centers worldwide. During the course of the trial, two MRIs will be obtained from each patient: one unenhanced and gadopiclenol-enhanced MRI; and one unenhanced and gadobutrol-enhanced MRI. MRI evaluations will be performed by on-site investigators and three independent off-site blinded readers.

Official Title
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Efficacy and Safety of Gadopiclenol for Central Nervous System (CNS) Magnetic Resonance Imaging (MRI)

Conditions
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CNS Lesion, Blood Brain Barrier Defect

Intervention / Treatment
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* Drug: gadopiclenol
* Drug: Gadobutrol 1Mmol/mL Solution for Injection Vial


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient presenting with known or highly suspected CNS lesion(s) with focal areas of disrupted Blood Brain Barrier (BBB) (e.g., primary and secondary tumors) based on results of a previous imaging procedure such as Computed Tomography (CT) or MRI, which should have been performed within 12 months prior to ICF signature. 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 injection Patient presenting extra cranial lesions and/or extra-dural lesions.

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 |
| --- | --- |
| Other: gadopiclenol-enhanced MRI then gadobutrol-enhanced MRI<br>cross-over design. each patient will receive gadopiclenol for the first MRI and gadobutrol for the second MRI | Drug: gadopiclenol<br>* single intravenous (IV) bolus injection at a rate of 2ml/second<br>Drug: Gadobutrol 1Mmol/mL Solution for Injection Vial<br>* single intravenous (IV) bolus injection at a rate of 2ml/second<br>|
| Other: gadobutrol-enhanced MRI then gadopiclenol-enhanced MRI<br>cross-over design. each patient will receive gadobutrol for the first MRI and gadopiclenol for the second MRI | Drug: gadopiclenol<br>* single intravenous (IV) bolus injection at a rate of 2ml/second<br>Drug: Gadobutrol 1Mmol/mL Solution for Injection Vial<br>* single intravenous (IV) bolus injection at a rate of 2ml/second<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 on the images acquired during the MRI performed with gadopiclenol by independent readers for the 3 most representative lesions. | 1 day procedure | 
| Lesion visualization criteria for gadopiclenol compared to gadobutrol | the lesion visualization criteria is based on 3 co-primary criteria: border delineation, internal morphology and degree of contrast enhancement assessed on the images acquired during the MRI performed with gadopiclenol and those performed with gadobutrol. For each reader, only matching lesion between paired images of gadobutrol and gadopiclenol will be considered | 1 day procedure |