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Trial record 2 of 9 for:    gadopiclenol

Efficacy and Safety of Gadopiclenol for Central Nervous System (CNS) Magnetic Resonance Imaging (MRI) (PICTURE)

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: NCT03996447
Recruitment Status : Completed
First Posted : June 24, 2019
Last Update Posted : July 2, 2021
Sponsor:
Information provided by (Responsible Party):
Guerbet

Tracking Information
First Submitted Date  ICMJE June 21, 2019
First Posted Date  ICMJE June 24, 2019
Last Update Posted Date July 2, 2021
Actual Study Start Date  ICMJE June 3, 2019
Actual Primary Completion Date September 11, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 21, 2019)
  • 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 on the images acquired during the MRI performed with gadopiclenol by independent readers for the 3 most representative lesions.
  • Lesion visualization criteria for gadopiclenol compared to gadobutrol [ 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 on the images acquired during the MRI performed with gadopiclenol and those performed with gadobutrol. For each reader, only matching lesion between paired images of gadobutrol and gadopiclenol will be considered
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 Central Nervous System (CNS) Magnetic Resonance Imaging (MRI)
Official Title  ICMJE Efficacy and Safety of Gadopiclenol for Central Nervous System (CNS) Magnetic Resonance Imaging (MRI)
Brief Summary the trial aims to evaluate the Efficacy and Safety of gadopiclenol for Central Nervous System (CNS) Magnetic Resonance Imaging (MRI)
Detailed Description

The purpose of this trial is to evaluate a new gadolinium-based contrast agent (GBCA) gadopiclenol injection for Central Nervous System (CNS) lesion detection and visualization by conventional steady-state CNS imaging. .

This is a multi-center, international, prospective, double-blind, randomized, controlled,cross-over with comparator trial in male and female patients presenting with known or highly suspected CNS lesion(s) with focal areas of disrupted Blood Brain Barrier (BBB) (e.g., primary and secondary tumors) who are scheduled to undergo a routine contrast-enhanced Magnetic Resonance Imaging (MRI) of the CNS.

This trial will be conducted in approximately 40 centers worldwide.

During the course of the trial, two MRIs will be obtained from each patient: one unenhanced and gadopiclenol-enhanced MRI; and one unenhanced and gadobutrol-enhanced MRI. MRI evaluations will be performed by on-site investigators and three 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
  • CNS Lesion
  • Blood Brain Barrier Defect
Intervention  ICMJE
  • Drug: gadopiclenol
    single intravenous (IV) bolus injection at a rate of 2ml/second
  • Drug: Gadobutrol 1Mmol/mL Solution for Injection Vial
    single intravenous (IV) bolus injection at a rate of 2ml/second
Study Arms  ICMJE
  • gadopiclenol-enhanced MRI then gadobutrol-enhanced MRI
    cross-over design. each patient will receive gadopiclenol for the first MRI and gadobutrol for the second MRI
    Interventions:
    • Drug: gadopiclenol
    • Drug: Gadobutrol 1Mmol/mL Solution for Injection Vial
  • gadobutrol-enhanced MRI then gadopiclenol-enhanced MRI
    cross-over design. each patient will receive gadobutrol for the first MRI and gadopiclenol for the second MRI
    Interventions:
    • Drug: gadopiclenol
    • Drug: Gadobutrol 1Mmol/mL Solution for Injection Vial
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: November 30, 2020)
260
Original Estimated Enrollment  ICMJE
 (submitted: June 21, 2019)
250
Actual Study Completion Date  ICMJE September 11, 2020
Actual Primary Completion Date September 11, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patient presenting with known or highly suspected CNS lesion(s) with focal areas of disrupted Blood Brain Barrier (BBB) (e.g., primary and secondary tumors) based on results of a previous imaging procedure such as Computed Tomography (CT) or MRI, which should have been performed within 12 months prior to ICF signature.

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 injection
  • Patient presenting extra cranial lesions and/or extra-dural lesions.
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 Belgium,   France,   Germany,   Hungary,   Italy,   Korea, Republic of,   Mexico,   Poland,   Spain,   Taiwan,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03996447
Other Study ID Numbers  ICMJE GDX-44-010
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 Not Provided
Current Responsible Party Guerbet
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Guerbet
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Lorie Loevner, MD University of Pennsylvania
PRS Account Guerbet
Verification Date May 2021

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