The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03986138
Recruitment Status : Completed
First Posted : June 14, 2019
Last Update Posted : November 10, 2021
Sponsor:
Information provided by (Responsible Party):
Guerbet

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
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 : August 27, 2019
Actual Primary Completion Date : December 9, 2020
Actual Study Completion Date : December 9, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: MRI Scans

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Lesion visualization criteria for gadopiclenol-enhanced MRI compared to unenhanced MRI [ Time Frame: 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

  2. Lesion visualization criteria for gadopiclenol-enhanced MRI compared to gadobutrol-enhanced MRI [ Time Frame: 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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03986138


Locations
Show Show 33 study locations
Sponsors and Collaborators
Guerbet
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Guerbet
ClinicalTrials.gov Identifier: NCT03986138    
Other Study ID Numbers: GDX-44-011
First Posted: June 14, 2019    Key Record Dates
Last Update Posted: November 10, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No