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

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

Study Overview

• Status: Completed
• Conditions: Blood Brain Barrier Defect; CNS Lesion
• Intervention / Treatment: Drug: gadopiclenol; Drug: Gadobutrol 1Mmol/mL Solution for Injection Vial

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.

• Study Type: Interventional
• Enrollment (Actual): 260
• Phase: Phase 3

Contacts and Locations

Study Locations

• Belgium
  • Antwerp, Belgium
    • ZNA Middelheim
  • Brussel, Belgium, 1090
    • UZ Brussel - Campus Jette
• France
  • Lille, France
    • CHRU - Hôpital Roger Salengro - Neurologie
  • Paris, France, 75014
    • Centre Hospitalier Sainte-Anne
  • Poitiers, France
    • CHU La Miletrie
  • Strasbourg, France, 67098
    • CHRU Strasbourg Hôpital de Hautepierre
• Germany
  • Mannheim, Germany, 68167
    • Uniklinik Mannheim
• Hungary
  • Budapest, Hungary, 1145
    • Országos Klinikai Idegtudományi Intézet
  • Budapest, Hungary, 1083
    • Semmelweis Egyetem - Neurology
  • Debrecen, Hungary
    • Debreceni Egyetem Klinikai Központ
  • Pécs, Hungary, Pécs
    • Pecsi Tudomanyegyetem Klinikai Kozpont - Idegsebeszeti Klinika
  • Szeged, Hungary, 6725
    • Szegedi Tudományegyetem ÁOK
• Italy
  • L'Aquila, Italy
    • ASL 1 Abruzzo Avezzano-Sulmona-L'Aquila, Ospedale Regionale San Salvatore
  • Pavia, Italy, 27100
    • Fondazione I.R.C.C.S. C.Mondino
  • Pozzilli, Italy, 86077
    • Istituto Neurologico Mediterraneo-Neuromed, I.R.C.C.S.
  • Trieste, Italy, 34149
    • Azienda Sanitaria Universitaria Integrata di Trieste-PO Cattinara
• Korea, Republic of
  • Seoul, Korea, Republic of, 05030
    • Konkuk University Medical Center
  • Seoul, Korea, Republic of, 5505
    • Asan Medical Center
• Mexico
  • Monterrey, Mexico, 64060
    • Axis Heilsa S. de R.L. de C.V. (Althian)
  • Tlalnepantla de Baz, Mexico, 54055
    • Clinical Research Institute S.C
• Poland
  • Gdańsk, Poland, 80-214
    • Uniwersyteckie Centrum Kliniczne w Gdańsku, Zakład Radiologii
• Spain
  • Barcelona, Spain, 08003
    • Hospital Del Mar
  • Madrid, Spain, 28040
    • Hospital Clínico San Carlos
  • Madrid, Spain, 28033
    • M.D. Anderson Cancer Center Madrid
• Taiwan
  • Taipei, Taiwan, 11217
    • Taipei Veterans General Hospital
• United States
  • California
    • Panorama City, California, United States, 91402
      • ASCLEPES Research Centers
  • Connecticut
    • Farmington, Connecticut, United States, 06030
      • University of Connecticut Health Center
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern Memorial Hospital
    • Rolling Meadows, Illinois, United States, 600008
      • Northwest Neurology, Ltd.
  • Missouri
    • Columbia, Missouri, United States, 65212
      • University of Missouri Hospital and Clinic
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • South Carolina Clinical & Translational Research (SCTR) Institute
  • Washington
    • Seattle, Washington, United States, 98195
      • University Of Washington - Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: gadopiclenol-enhanced MRI then gadobutrol-enhanced MRI; cross-over design. each patient will receive gadopiclenol for the first MRI and gadobutrol for the second MRI	Drug: gadopiclenol; single intravenous (IV) bolus injection at a rate of 2ml/second; Drug: Gadobutrol 1Mmol/mL Solution for Injection Vial; single intravenous (IV) bolus injection at a rate of 2ml/second
Other: gadobutrol-enhanced MRI then gadopiclenol-enhanced MRI; cross-over design. each patient will receive gadobutrol for the first MRI and gadopiclenol for the second MRI	Drug: gadopiclenol; single intravenous (IV) bolus injection at a rate of 2ml/second; Drug: Gadobutrol 1Mmol/mL Solution for Injection Vial; single intravenous (IV) bolus injection at a rate of 2ml/second

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Guerbet
• Investigators: Principal Investigator: Lorie Loevner, MD, University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): June 3, 2019
• Primary Completion (Actual): September 11, 2020
• Study Completion (Actual): September 11, 2020

Study Registration Dates

• First Submitted: June 21, 2019
• First Submitted That Met QC Criteria: June 21, 2019
• First Posted (Actual): June 24, 2019

Study Record Updates

• Last Update Posted (Actual): July 2, 2021
• Last Update Submitted That Met QC Criteria: June 30, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: GDX-44-010

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No