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

This trial aimed 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 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.

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

Contacts and Locations

Study Locations

• Belgium
  • Antwerp, Belgium
    • ZNA Middelheim
  • Brussels, 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 Kozpont
  • 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
• Mexico
  • Monterrey, Mexico, 64060
    • Axis Heilsa S. de R.L. de C.V. (Althian)
  • Tlalnepantla, Mexico, 54055
    • Clinical Research Institute S.C
• Poland
  • Gdansk, Poland, 80-214
    • Uniwersyteckie Centrum Kliniczne w Gdańsku, Zakład Radiologii
• South Korea
  • Seoul, South Korea, 05030
    • Konkuk University Medical Center
  • Seoul, South Korea, 5505
    • Asan Medical Center
• Spain
  • Barcelona, Spain, 08003
    • Hospital del Mar
  • Madrid, Spain, 28040
    • Hospital Clinico 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: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

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 Comparing Gadopiclenol-enhanced MRI to Unenhanced MRI	The lesion visualization (per patient) was based on 3 co-primary criteria on marching lesions: border delineation, internal morphology and degree of contrast enhancement, assessed on the images acquired during the MRI performed with gadopiclenol by 3 independent readers. The independent blinded reader recorded each of the 3 co-primary criteria for up to 3 most representative lesions, using a 4-point scale (1 = poor [internal morphology] or none [border delineation, contrast enhancement], 2 = moderate, 3 = good, 4 = excellent). The mean of scores for each patient and for each co-criterion was calculated as follows: Mean of scores = score of lesion 1 + score of lesion 2 (if any) + score of lesion 3 (if any) divided by the number of lesions, ranged from 1 to 4. The difference in mean scores on matching lesions between Paired [unenhanced and contrast-enhanced] images and Pre-contrast [unenhanced] images was calculated for each of the 3 co-primary criteria and for each reader.	At first MRI examination (gadopiclenol-enhanced MRI) for patients of Arm 1. At second MRI examination (gadopiclenol-enhanced MRI) for patients of Arm 2, performed 2-14 days after gadobutrol-enhanced MRI.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lesion Visualization Comparing Gadopiclenol-enhanced MRI to Gadobutrol-enhanced MRI	The lesion visualization (per patient) was based on 3 co-primary criteria: border delineation, internal morphology and degree of contrast enhancement, assessed on the images performed with gadopiclenol and images performed with gadobutrol by 3 independent readers. The independent blinded reader recorded each of the 3 co-primary criteria for up to 3 most representative lesions, using a 4-point scale (1 = poor [internal morphology] or none [border delineation, contrast enhancement], 2 = moderate, 3 = good, 4 = excellent). The mean of scores for each patient and for each of the 3 lesion visualization co-criteria was calculated as follows: Mean of scores = score of lesion 1 + score of lesion 2 (if any) + score of lesion 3 (if any) divided by the number of lesions, ranged from 1 to 4. The difference in mean scores on matching lesions between gadopiclenol scores mean and gadobutrol scores mean was calculated for each of the 3 co-primary criteria and for each reader.	At each of two MRI examinations with an interval of 2-14 days between 2 MRI examinations

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Loevner LA, Kolumban B, Hutoczki G, Dziadziuszko K, Bereczki D, Bago A, Pichiecchio A. Efficacy and Safety of Gadopiclenol for Contrast-Enhanced MRI of the Central Nervous System: The PICTURE Randomized Clinical Trial. Invest Radiol. 2023 May 1;58(5):307-313. doi: 10.1097/RLI.0000000000000944. Epub 2022 Dec 19.

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 (Estimated): September 22, 2025
• Last Update Submitted That Met QC Criteria: September 17, 2025
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pharmaceutical Preparations; Solutions; gadobutrol; gadopiclenol
• 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