Clinical trial NCT03996447: Efficacy and Safety of Gadopiclenol for Central Nervous System (CNS) Magnetic Resonance Imaging (MRI)
Official title: Efficacy and Safety of Gadopiclenol for Central Nervous System (CNS) Magnetic Resonance Imaging (MRI)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: CNS Lesion
Blood Brain Barrier Defect
Lead sponsor: Guerbet
Sponsor class: INDUSTRY
First posted: 2019-06-24
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: the trial aims to evaluate the Efficacy and Safety of gadopiclenol for Central Nervous System (CNS) Magnetic Resonance Imaging (MRI)

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: lesion visualization criteria for gadopiclenol-enhanced MRI compared to unenhanced MRI
timeFrame: 1 day procedure
measure: Lesion visualization criteria for gadopiclenol compared to gadobutrol
timeFrame: 1 day procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Panorama City
country: United States
facility: ASCLEPES Research Centers
state: California
city: Farmington
country: United States
facility: University of Connecticut Health Center
state: Connecticut
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: Rolling Meadows
country: United States
facility: Northwest Neurology, Ltd.
state: Illinois
city: Columbia
country: United States
facility: University of Missouri Hospital and Clinic
state: Missouri
city: Philadelphia
country: United States
facility: University Of Pennsylvania
state: Pennsylvania
city: Charleston
country: United States
facility: South Carolina Clinical & Translational Research (SCTR) Institute
state: South Carolina
city: Seattle
country: United States
facility: University Of Washington - Medical Center
state: Washington
city: Antwerp
country: Belgium
facility: ZNA Middelheim
city: Brussel
country: Belgium
facility: UZ Brussel - Campus Jette
city: Lille
country: France
facility: CHRU - Hôpital Roger Salengro - Neurologie
city: Paris
country: France
facility: Centre Hospitalier Sainte-Anne
city: Poitiers
country: France
facility: CHU La Miletrie
city: Strasbourg
country: France
facility: CHRU Strasbourg Hôpital de Hautepierre
city: Mannheim
country: Germany
facility: Uniklinik Mannheim
city: Budapest
country: Hungary
facility: Semmelweis Egyetem - Neurology
city: Budapest
country: Hungary
facility: Orszagos Klinikai Idegtudomanyi Intezet
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont
city: Pécs
country: Hungary
facility: Pecsi Tudomanyegyetem Klinikai Kozpont - Idegsebeszeti Klinika
city: Szeged
country: Hungary
facility: Szegedi Tudomanyegyetem AOK
city: L'Aquila
country: Italy
facility: ASL 1 Abruzzo Avezzano-Sulmona-L'Aquila, Ospedale Regionale San Salvatore
city: Pavia
country: Italy
facility: Fondazione I.R.C.C.S. C.Mondino
city: Pozzilli
country: Italy
facility: Istituto Neurologico Mediterraneo-Neuromed, I.R.C.C.S.
city: Trieste
country: Italy
facility: Azienda Sanitaria Universitaria Integrata di Trieste-PO Cattinara
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Monterrey
country: Mexico
facility: Axis Heilsa S. de R.L. de C.V. (Althian)
city: Tlalnepantla de Baz
country: Mexico
facility: Clinical Research Institute S.C
city: Gdańsk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne w Gdańsku, Zakład Radiologii
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Madrid
country: Spain
facility: M.D. Anderson Cancer Center Madrid
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
affiliation: University of Pennsylvania
name: Lorie Loevner, MD
role: PRINCIPAL_INVESTIGATOR
References: