Efficacy and Safety of Gadopiclenol for Body Magnetic Resonance Imaging (MRI)

NCT03986138 | Completed Phase 3 Results FDA Drug

• 1 other identifier: GDX-44-011
• Study Type: interventional
• Target: 324
• Locations: 11 countries
• Sites: 33

Brief Summary

The trial aimed at evaluating the efficacy and the safety of gadopiclenol for body Magnetic resonance Imaging (MRI)

Conditions

Lesion in Body Region

Outcome Measures

Primary Outcomes (1)

• Lesion Visualization Comparing Gadopiclenol-enhanced MRI to Unenhanced MRI

  The lesion visualization at patient level 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 two MRI examinations

Study Arms (2)

gadopiclenol-enhanced MRI then gadobutrol-enhanced MRI

EXPERIMENTAL

Cross-over design: each patient receives gadopiclenol for the first MRI and then gadobutrol for the second MRI

Drug: gadopiclenol; Drug: Gadobutrol 1 MMOLE/ML Intravenous Solution

gadobutrol-enhanced MRI then gadopiclenol-enhanced MRI

EXPERIMENTAL

Cross-over design: each patient receives gadobutrol for the first MRI and then gadopiclenol for the second MRI

Drug: gadopiclenol; Drug: Gadobutrol 1 MMOLE/ML Intravenous Solution

Interventions

gadopiclenol DRUG

Single intravenous bolus injection

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

Gadobutrol 1 MMOLE/ML Intravenous Solution DRUG

Single intravenous bolus injection

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 suspected enhancing abnormality(ies) and/or lesion(s) in at least one body region based on a previous imaging procedure performed within 12 months prior to ICF signature. US patients are restricted to the breast in compliance with local approved indications of gadobutrol.

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 administration.

Sponsors & Collaborators

• Guerbet: lead

Study Sites (33)

The University of Alabama at Birmingham

Birmingham, Alabama, 35249, United States

Location

UConn Health - University of Connecticut

Farmington, Connecticut, 06030-2802, United States

Location

The University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

University of Missouri Health System

Columbia, Missouri, 65212, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

UT Health San Antonio

San Antonio, Texas, 78207, United States

Location

Acibadem City Clinic Tokuda Hospital Sofia

Sofia, Bulgaria

Location

CHU

Angers, France

Location

CHU Beaujon

Clichy, France

Location

Hôpital Saint Louis

Paris, France

Location

Klinik für Diagnostische und Interventionelle Radiologie

Aachen, Germany

Location

Universitätsklinikum Halle

Halle, Germany

Location

Universitätsklinikum des Saarlandes

Homburg, Germany

Location

University Hospital Jena

Jena, Germany

Location

Somogy Megyei Kaposi Mor Oktato Korhaz

Kaposvár, Hungary

Location

Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet

Szolnok, Hungary

Location

Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale"

Napoli, Italy

Location

Clinical Research Institute S.C.

Estado de México, Mexico

Location

Axis Heilsa S de R.L. de C.V - Althian Clinical Research Management Center

Monterrey, Mexico

Location

Szpital Uniwersytecki Nr 1 im. dr Antoniego Jurasza w Bydgoszczy

Bydgoszcz, Poland

Location

Uniwersyteckie Centrum Kliniczne

Gdansk, Poland

Location

Jagiellońskie Centrum Innowacji Sp. z o. o.

Krakow, Poland

Location

Szpital Świętego Rafała

Krakow, Poland

Location

Centrum Medyczne Affidea Wałbrzych

Wałbrzych, Poland

Location

Inje University Busan Paik Hospital

Busan, South Korea

Location

Bucheon Suncheonhyang Hospital

Gyeonggi-do, South Korea

Location

Korea University Anam Hospital

Seoul, South Korea

Location

Samsung Medical Center

Seoul, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

Hospital Universitario y Politécnico La Fe

Valencia, Spain

Location

St. Luke's Hospital

Kropyvnytskyi, Ukraine

Location

Borys Clinic

Kyiv, Ukraine

Location

Related Publications (1)

• Kuhl C, Csoszi T, Piskorski W, Miszalski T, Lee JM, Otto PM. Efficacy and Safety of Half-Dose Gadopiclenol versus Full-Dose Gadobutrol for Contrast-enhanced Body MRI. Radiology. 2023 Jul;308(1):e222612. doi: 10.1148/radiol.222612.

  PMID: 37462494 RESULT

MeSH Terms

Interventions

gadopiclenol

Results Point of Contact

• Title: Frantz Hebert, Global Head of Clinical Development
• Organization: Guerbet

frantz.hebert@guerbet.com

+33 (0)6 80 24 93 34

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 11, 2019
• First Posted: June 14, 2019
• Study Start: August 27, 2019
• Primary Completion: December 9, 2020
• Study Completion: December 9, 2020
• Last Updated: October 27, 2025
• Results First Posted: October 27, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (4); ES (1); IT (1); ME (2); BU (1); HU (2); PL (5); KR (5); UA (2); US (7); FR (3)