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

NCT03996447 | Completed Phase 3 Results FDA Drug

• 1 other identifier: GDX-44-010
• Study Type: interventional
• Target: 260
• Locations: 11 countries
• Sites: 33

Brief Summary

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

Conditions

CNS Lesion; Blood Brain Barrier Defect

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Lesion Visualization Comparing Gadopiclenol-enhanced MRI to Gadobutrol-enhanced MRI

  At each of two MRI examinations with an interval of 2-14 days between 2 MRI examinations

Study Arms (2)

gadopiclenol-enhanced MRI then gadobutrol-enhanced MRI

OTHER

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

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

gadobutrol-enhanced MRI then gadopiclenol-enhanced MRI

OTHER

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

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

Interventions

gadopiclenol DRUG

single intravenous (IV) bolus injection at a rate of 2ml/second

gadobutrol-enhanced MRI then gadopiclenol-enhanced MRI; gadopiclenol-enhanced MRI then gadobutrol-enhanced MRI

Gadobutrol 1Mmol/mL Solution for Injection Vial DRUG

single intravenous (IV) bolus injection at a rate of 2ml/second

gadobutrol-enhanced MRI then gadopiclenol-enhanced MRI; gadopiclenol-enhanced MRI then gadobutrol-enhanced MRI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guerbet: lead

Study Sites (33)

ASCLEPES Research Centers

Panorama City, California, 91402, United States

Location

University of Connecticut Health Center

Farmington, Connecticut, 06030, United States

Location

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

Northwest Neurology, Ltd.

Rolling Meadows, Illinois, 600008, United States

Location

University of Missouri Hospital and Clinic

Columbia, Missouri, 65212, United States

Location

University Of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

South Carolina Clinical & Translational Research (SCTR) Institute

Charleston, South Carolina, 29425, United States

Location

University Of Washington - Medical Center

Seattle, Washington, 98195, United States

Location

ZNA Middelheim

Antwerp, Belgium

Location

UZ Brussel - Campus Jette

Brussels, 1090, Belgium

Location

CHRU - Hôpital Roger Salengro - Neurologie

Lille, France

Location

Centre Hospitalier Sainte-Anne

Paris, 75014, France

Location

CHU La Miletrie

Poitiers, France

Location

CHRU Strasbourg Hôpital de Hautepierre

Strasbourg, 67098, France

Location

Uniklinik Mannheim

Mannheim, 68167, Germany

Location

Semmelweis Egyetem - Neurology

Budapest, 1083, Hungary

Location

Orszagos Klinikai Idegtudomanyi Intezet

Budapest, 1145, Hungary

Location

Debreceni Egyetem Klinikai Kozpont

Debrecen, Hungary

Location

Pecsi Tudomanyegyetem Klinikai Kozpont - Idegsebeszeti Klinika

Pécs, Pécs, Hungary

Location

Szegedi Tudomanyegyetem AOK

Szeged, 6725, Hungary

Location

ASL 1 Abruzzo Avezzano-Sulmona-L'Aquila, Ospedale Regionale San Salvatore

L’Aquila, Italy

Location

Fondazione I.R.C.C.S. C.Mondino

Pavia, 27100, Italy

Location

Istituto Neurologico Mediterraneo-Neuromed, I.R.C.C.S.

Pozzilli, 86077, Italy

Location

Azienda Sanitaria Universitaria Integrata di Trieste-PO Cattinara

Trieste, 34149, Italy

Location

Axis Heilsa S. de R.L. de C.V. (Althian)

Monterrey, 64060, Mexico

Location

Clinical Research Institute S.C

Tlalnepantla, 54055, Mexico

Location

Uniwersyteckie Centrum Kliniczne w Gdańsku, Zakład Radiologii

Gdansk, 80-214, Poland

Location

Konkuk University Medical Center

Seoul, 05030, South Korea

Location

Asan Medical Center

Seoul, 5505, South Korea

Location

Hospital del Mar

Barcelona, 08003, Spain

Location

M.D. Anderson Cancer Center Madrid

Madrid, 28033, Spain

Location

Hospital Clínico San Carlos

Madrid, 28040, Spain

Location

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 36729404 RESULT

MeSH Terms

Interventions

gadopiclenol; gadobutrol; Solutions

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations

Results Point of Contact

• Title: Jing Hao, MD, Global Head of Medical Affairs & Clinical Development
• Organization: Guerbet

jing.hao@guerbet.com

+33 (0) 1 45 91 50 00

Study Officials

• Lorie Loevner, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2019
• First Posted: June 24, 2019
• Study Start: June 3, 2019
• Primary Completion: September 11, 2020
• Study Completion: September 11, 2020
• Last Updated: September 22, 2025
• Results First Posted: September 22, 2025

Record last verified: 2023-11

Locations

HU (5); US (8); FR (4); KR (2); ES (3); TW (1); PL (1); ME (2); DE (1); IT (4); BE (2)