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

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

Study Overview

• Status: Completed
• Conditions: Lesion in Body Region
• Intervention / Treatment: Drug: gadopiclenol; Drug: Gadobutrol 1 MMOLE/ML Intravenous Solution

Detailed Description

The purpose of this trial was to evaluate a new gadolinium-based contrast agent (GBCA) gadopiclenol in terms of lesion visualization in patients referred for contrast-enhanced MRI of body regions.

This is a prospective, international, multi-center, randomized, double-blind, controlled and cross-over trial.

This trial was conducted in 33 centers worldwide. During the course of the trial, two MRIs were obtained from each patient: one with gadopiclenol and one with gadobutrol. MRI evaluations were assessed by independent off-site blinded readers.

• Study Type: Interventional
• Enrollment (Actual): 324
• Phase: Phase 3

Contacts and Locations

Study Locations

• Bulgaria
  • Sofia, Bulgaria
    • Acibadem City Clinic Tokuda Hospital Sofia
• France
  • Angers, France
    • CHU
  • Clichy, France
    • Chu Beaujon
  • Paris, France
    • Hopital saint Louis
• Germany
  • Aachen, Germany
    • Klinik für Diagnostische und Interventionelle Radiologie
  • Halle, Germany
    • Universitatsklinikum Halle
  • Homburg, Germany
    • Universitätsklinikum des Saarlandes
  • Jena, Germany
    • University Hospital Jena
• Hungary
  • Kaposvár, Hungary
    • Somogy Megyei Kaposi Mor Oktato Korhaz
  • Szolnok, Hungary
    • Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház-Rendelőintézet
• Italy
  • Napoli, Italy
    • Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale"
• Mexico
  • Estado de México, Mexico
    • Clinical Research Institute S.C.
  • Monterrey, Mexico
    • Axis Heilsa S de R.L. de C.V - Althian Clinical Research Management Center
• Poland
  • Bydgoszcz, Poland
    • Szpital Uniwersytecki Nr 1 im. dr Antoniego Jurasza w Bydgoszczy
  • Gdansk, Poland
    • Uniwersyteckie Centrum Kliniczne
  • Krakow, Poland
    • Jagiellońskie Centrum Innowacji Sp. z o. o.
  • Krakow, Poland
    • Szpital Świętego Rafała
  • Wałbrzych, Poland
    • Centrum Medyczne Affidea Wałbrzych
• South Korea
  • Busan, South Korea
    • Inje University Busan Paik Hospital
  • Gyeonggi-do, South Korea
    • Bucheon Suncheonhyang Hospital
  • Seoul, South Korea
    • Korea University Anam Hospital
  • Seoul, South Korea
    • Samsung Medical Center
  • Seoul, South Korea
    • Seoul National University Hospital
• Spain
  • Valencia, Spain
    • Hospital Universitario y Politecnico La Fe
• Ukraine
  • Kropyvnytskyi, Ukraine
    • St. Luke's Hospital
  • Kyiv, Ukraine
    • Borys Clinic
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35249
      • The University of Alabama at Birmingham
  • Connecticut
    • Farmington, Connecticut, United States, 06030-2802
      • UConn Health - University of Connecticut
  • Illinois
    • Chicago, Illinois, United States, 60637
      • The University of Chicago Medical Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center
  • Missouri
    • Columbia, Missouri, United States, 65212
      • University of Missouri Health System
  • New York
    • The Bronx, New York, United States, 10467
      • Montefiore Medical Center
  • Texas
    • San Antonio, Texas, United States, 78207
      • UT Health San Antonio

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 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.

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 administration.

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
Experimental: gadopiclenol-enhanced MRI then gadobutrol-enhanced MRI; Cross-over design: each patient receives gadopiclenol for the first MRI and then gadobutrol for the second MRI	Drug: gadopiclenol; Single intravenous bolus injection; Drug: Gadobutrol 1 MMOLE/ML Intravenous Solution; Single intravenous bolus injection
Experimental: gadobutrol-enhanced MRI then gadopiclenol-enhanced MRI; Cross-over design: each patient receives gadobutrol for the first MRI and then gadopiclenol for the second MRI	Drug: gadopiclenol; Single intravenous bolus injection; Drug: Gadobutrol 1 MMOLE/ML Intravenous Solution; Single intravenous bolus injection

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 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 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 two MRI examinations

Collaborators and Investigators

• Sponsor: Guerbet

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 27, 2019
• Primary Completion (Actual): December 9, 2020
• Study Completion (Actual): December 9, 2020

Study Registration Dates

• First Submitted: June 11, 2019
• First Submitted That Met QC Criteria: June 11, 2019
• First Posted (Actual): June 14, 2019

Study Record Updates

• Last Update Posted (Estimated): October 27, 2025
• Last Update Submitted That Met QC Criteria: October 13, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: gadopiclenol
• Other Study ID Numbers: GDX-44-011

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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