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

Guerbet

Status and phase: Completed; Phase 3

Conditions: Lesion in Body Region

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT03986138

GDX-44-011

Details and patient eligibility

About

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

Full 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.

Enrollment: 324 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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324 participants in 2 patient groups

gadopiclenol-enhanced MRI then gadobutrol-enhanced MRI

Experimental group

Description:

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

Treatment:

Drug: gadopiclenol

Drug: Gadobutrol 1 MMOLE/ML Intravenous Solution

gadobutrol-enhanced MRI then gadopiclenol-enhanced MRI

Experimental group

Description:

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

Treatment:

Drug: gadopiclenol

Drug: Gadobutrol 1 MMOLE/ML Intravenous Solution