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

Blood Brain Barrier Defect Clinical Trial

— PICTURE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03996447
• Other study ID #: GDX-44-010
• Status: Completed
• Phase: Phase 3
• Start date: June 3, 2019
• Est. completion date: September 11, 2020

Study information

• Verified date: May 2021
• Source: Guerbet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 260
• Est. completion date: September 11, 2020
• Est. primary completion date: September 11, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Blood Brain Barrier Defect
• CNS Lesion

Intervention

Drug:
• gadopiclenol
single intravenous (IV) bolus injection at a rate of 2ml/second
• Gadobutrol 1Mmol/mL Solution for Injection Vial
single intravenous (IV) bolus injection at a rate of 2ml/second

Locations

Country	Name	City	State
Belgium	ZNA Middelheim	Antwerp
Belgium	UZ Brussel - Campus Jette	Brussel
France	CHRU - Hôpital Roger Salengro - Neurologie	Lille
France	Centre Hospitalier Sainte-Anne	Paris
France	CHU La Miletrie	Poitiers
France	CHRU Strasbourg Hôpital de Hautepierre	Strasbourg
Germany	Uniklinik Mannheim	Mannheim
Hungary	Orszagos Klinikai Idegtudomanyi Intezet	Budapest
Hungary	Semmelweis Egyetem - Neurology	Budapest
Hungary	Debreceni Egyetem Klinikai Kozpont	Debrecen
Hungary	Pecsi Tudomanyegyetem Klinikai Kozpont - Idegsebeszeti Klinika	Pécs
Hungary	Szegedi Tudomanyegyetem AOK	Szeged
Italy	ASL 1 Abruzzo Avezzano-Sulmona-L'Aquila, Ospedale Regionale San Salvatore	L'Aquila
Italy	Fondazione I.R.C.C.S. C.Mondino	Pavia
Italy	Istituto Neurologico Mediterraneo-Neuromed, I.R.C.C.S.	Pozzilli
Italy	Azienda Sanitaria Universitaria Integrata di Trieste-PO Cattinara	Trieste
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Konkuk University Medical Center	Seoul
Mexico	Axis Heilsa S. de R.L. de C.V. (Althian)	Monterrey
Mexico	Clinical Research Institute S.C	Tlalnepantla de Baz
Poland	Uniwersyteckie Centrum Kliniczne w Gdansku, Zaklad Radiologii	Gdansk
Spain	Hospital del Mar	Barcelona
Spain	Hospital Clínico San Carlos	Madrid
Spain	M.D. Anderson Cancer Center Madrid	Madrid
Taiwan	Taipei Veterans General Hospital	Taipei
United States	South Carolina Clinical & Translational Research (SCTR) Institute	Charleston	South Carolina
United States	Northwestern Memorial Hospital	Chicago	Illinois
United States	University of Missouri Hospital and Clinic	Columbia	Missouri
United States	University of Connecticut Health Center	Farmington	Connecticut
United States	ASCLEPES Research Centers	Panorama City	California
United States	University Of Pennsylvania	Philadelphia	Pennsylvania
United States	Northwest Neurology, Ltd.	Rolling Meadows	Illinois
United States	University Of Washington - Medical Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Guerbet

Countries where clinical trial is conducted

United States,  Belgium,  France,  Germany,  Hungary,  Italy,  Korea, Republic of,  Mexico,  Poland,  Spain,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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