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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 : January 7, 2021
Sponsor:
Information provided by (Responsible Party):
Guerbet

Tracking Information
First Submitted Date  ICMJE June 11, 2019
First Posted Date  ICMJE June 14, 2019
Last Update Posted Date January 7, 2021
Actual Study Start Date  ICMJE August 27, 2019
Actual Primary Completion Date December 9, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 11, 2019)
  • Lesion visualization criteria for gadopiclenol-enhanced MRI compared to unhenhanced 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Gadopiclenol for Body Magnetic Resonance Imaging (MRI)
Official Title  ICMJE Efficacy and Safety of Gadopiclenol for Body Magnetic Resonance Imaging (MRI)
Brief Summary The trial aims at evaluating the efficacy and the safety of gadopiclenol for body Magnetic resonance Imaging (MRI)
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Condition  ICMJE Lesion in Body Region
Intervention  ICMJE
  • Drug: gadopiclenol
    Single intravenous bolus injection
  • Drug: Gadobutrol 1 MMOLE/ML Intravenous Solution
    Single intravenous bolus injection
Study Arms  ICMJE
  • 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
    Interventions:
    • Drug: gadopiclenol
    • Drug: Gadobutrol 1 MMOLE/ML Intravenous Solution
  • 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
    Interventions:
    • Drug: gadopiclenol
    • Drug: Gadobutrol 1 MMOLE/ML Intravenous Solution
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 6, 2021)
304
Original Estimated Enrollment  ICMJE
 (submitted: June 11, 2019)
250
Actual Study Completion Date  ICMJE December 9, 2020
Actual Primary Completion Date December 9, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Bulgaria,   France,   Germany,   Hungary,   Italy,   Korea, Republic of,   Mexico,   Poland,   Spain,   Ukraine,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03986138
Other Study ID Numbers  ICMJE GDX-44-011
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Guerbet
Study Sponsor  ICMJE Guerbet
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Guerbet
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP