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

Sponsor

Guerbet (Industry)

Overall Status

Completed

CT.gov ID

NCT03986138

Collaborator

(none)

304

Enrollment

Locations

Arms

15.4

Actual Duration (Months)

9.2

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Lesion in Body Region	Drug: gadopiclenol Drug: Gadobutrol 1 MMOLE/ML Intravenous Solution	Phase 3

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

304 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Aug 27, 2019

Actual Primary Completion Date :

Dec 9, 2020

Actual Study Completion Date :

Dec 9, 2020

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Lesion visualization criteria for gadopiclenol-enhanced MRI compared to unenhanced MRI [1 day procedure]
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
Lesion visualization criteria for gadopiclenol-enhanced MRI compared to gadobutrol-enhanced MRI [1 day procedure]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The University of Alabama at Birmingham	Birmingham	Alabama	United States	35249
2	UConn Health - University of Connecticut	Farmington	Connecticut	United States	06030-2802
3	The University of Chicago Medical Center	Chicago	Illinois	United States	60637
4	Boston Medical Center	Boston	Massachusetts	United States	02118
5	University of Missouri Health System	Columbia	Missouri	United States	65212
6	Montefiore Medical Center	Bronx	New York	United States	10467
7	UT Health San Antonio	San Antonio	Texas	United States	78207
8	Acibadem City Clinic Tokuda Hospital Sofia	Sofia		Bulgaria
9	CHU	Angers		France
10	CHU Beaujon	Clichy la Garenne		France
11	Hôpital Saint Louis	Paris		France
12	Klinik für Diagnostische und Interventionelle Radiologie	Aachen		Germany
13	Universitätsklinikum Halle	Halle		Germany
14	Universitätsklinikum des Saarlandes	Homburg		Germany
15	University Hospital Jena	Jena		Germany
16	Somogy Megyei Kaposi Mor Oktato Korhaz	Kaposvár		Hungary
17	Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet	Szolnok		Hungary
18	Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale"	Napoli		Italy
19	Inje University Busan Paik Hospital	Busan		Korea, Republic of
20	Bucheon Suncheonhyang Hospital	Gyeonggi-do		Korea, Republic of
21	Korea University Anam Hospital	Seoul		Korea, Republic of
22	Samsung Medical Center	Seoul		Korea, Republic of
23	Seoul National University Hospital	Seoul		Korea, Republic of
24	Clinical Research Institute S.C.	Estado de Mexico		Mexico
25	Axis Heilsa S de R.L. de C.V - Althian Clinical Research Management Center	Monterrey		Mexico
26	Szpital Uniwersytecki Nr 1 im. dr Antoniego Jurasza w Bydgoszczy	Bydgoszcz		Poland
27	Uniwersyteckie Centrum Kliniczne	Gdańsk		Poland
28	Jagiellońskie Centrum Innowacji Sp. z o. o.	Kraków		Poland
29	Szpital Świętego Rafała	Kraków		Poland
30	Centrum Medyczne Affidea Wałbrzych	Wałbrzych		Poland
31	Hospital Universitario y Politécnico La Fe	Valencia		Spain
32	St. Luke's Hospital	Kropyvnytskyi		Ukraine
33	Borys Clinic	Kyiv		Ukraine

Sponsors and Collaborators

Guerbet

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Guerbet

ClinicalTrials.gov Identifier:

NCT03986138

Other Study ID Numbers:

GDX-44-011

First Posted:

Jun 14, 2019

Last Update Posted:

Nov 10, 2021

Last Verified:

Nov 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Nov 10, 2021