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

Lesion in Body Region Clinical Trial

— PROMISE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03986138
• Other study ID #: GDX-44-011
• Status: Completed
• Phase: Phase 3
• Start date: August 27, 2019
• Est. completion date: December 9, 2020

Study information

• Verified date: November 2021
• Source: Guerbet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

The purpose of this trial is 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 will be conducted in approximately 50 centers worldwide. During the course of the trial, two MRIs will be obtained from each patient: one with gadopiclenol and one with gadobutrol. MRI evaluations will be assessed by independent off-site blinded readers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 304
• Est. completion date: December 9, 2020
• Est. primary completion date: December 9, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lesion in Body Region

Intervention

Drug:
• gadopiclenol
Single intravenous bolus injection
• Gadobutrol 1 MMOLE/ML Intravenous Solution
Single intravenous bolus injection

Locations

Country	Name	City	State
Bulgaria	Acibadem City Clinic Tokuda Hospital Sofia	Sofia
France	CHU	Angers
France	CHU Beaujon	Clichy la Garenne
France	Hôpital Saint Louis	Paris
Germany	Klinik für Diagnostische und Interventionelle Radiologie	Aachen
Germany	Universitätsklinikum Halle	Halle
Germany	Universitätsklinikum des Saarlandes	Homburg
Germany	University Hospital Jena	Jena
Hungary	Somogy Megyei Kaposi Mor Oktato Korhaz	Kaposvár
Hungary	Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet	Szolnok
Italy	Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale"	Napoli
Korea, Republic of	Inje University Busan Paik Hospital	Busan
Korea, Republic of	Bucheon Suncheonhyang Hospital	Gyeonggi-do
Korea, Republic of	Korea University Anam Hospital	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Mexico	Clinical Research Institute S.C.	Estado de Mexico
Mexico	Axis Heilsa S de R.L. de C.V - Althian Clinical Research Management Center	Monterrey
Poland	Szpital Uniwersytecki Nr 1 im. dr Antoniego Jurasza w Bydgoszczy	Bydgoszcz
Poland	Uniwersyteckie Centrum Kliniczne	Gdansk
Poland	Jagiellonskie Centrum Innowacji Sp. z o. o.	Kraków
Poland	Szpital Swietego Rafala	Kraków
Poland	Centrum Medyczne Affidea Walbrzych	Walbrzych
Spain	Hospital Universitario y Politécnico La Fe	Valencia
Ukraine	St. Luke's Hospital	Kropyvnytskyi
Ukraine	Borys Clinic	Kyiv
United States	The University of Alabama at Birmingham	Birmingham	Alabama
United States	Boston Medical Center	Boston	Massachusetts
United States	Montefiore Medical Center	Bronx	New York
United States	The University of Chicago Medical Center	Chicago	Illinois
United States	University of Missouri Health System	Columbia	Missouri
United States	UConn Health - University of Connecticut	Farmington	Connecticut
United States	UT Health San Antonio	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Guerbet

Countries where clinical trial is conducted

United States,  Bulgaria,  France,  Germany,  Hungary,  Italy,  Korea, Republic of,  Mexico,  Poland,  Spain,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 by independent blinded readers on the images acquired during the MRI performed with gadopiclenol for up to 3 most representative lesions	1 day procedure
Primary	Lesion visualization criteria for gadopiclenol-enhanced MRI compared to gadobutrol-enhanced MRI	The lesion visualization criteria is based on 3 co-primary criteria: border delineation, internal morphology and degree of contrast enhancement, assessed by independent blinded readers on the images acquired during the MRI performed with gadopiclenol and MRI performed with gadobutrol for up to 3 most representative lesions	1 day procedure