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

Guerbet

Status and phase: Completed; Phase 3

Conditions: Blood Brain Barrier Defect; CNS Lesion

Treatments: Drug: Gadobutrol 1Mmol/mL Solution for Injection Vial; Drug: gadopiclenol

Study type: Interventional

Funder types: Industry

Identifiers

NCT03996447

GDX-44-010

Details and patient eligibility

About

This trial aimed to evaluate the Efficacy and Safety of gadopiclenol for Central Nervous System (CNS) Magnetic Resonance Imaging (MRI)

Full description

The purpose of this trial was 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 was conducted in 33 centers worldwide.

During the course of the trial, two MRIs were obtained from each patient: one unenhanced and gadopiclenol-enhanced MRI; and one unenhanced and gadobutrol-enhanced MRI. MRI evaluations were performed by on-site investigators and three independent off-site blinded readers.

Enrollment: 260 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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260 participants in 2 patient groups

gadopiclenol-enhanced MRI then gadobutrol-enhanced MRI

Other group

Description:

cross-over design. each patient will receive gadopiclenol for the first MRI and gadobutrol for the second MRI

Treatment:

Drug: gadopiclenol

Drug: Gadobutrol 1Mmol/mL Solution for Injection Vial

gadobutrol-enhanced MRI then gadopiclenol-enhanced MRI

Other group

Description:

cross-over design. each patient will receive gadobutrol for the first MRI and gadopiclenol for the second MRI

Treatment:

Drug: gadopiclenol

Drug: Gadobutrol 1Mmol/mL Solution for Injection Vial