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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03996447
Recruitment Status : Recruiting
First Posted : June 24, 2019
Last Update Posted : June 4, 2020
Sponsor:
Information provided by (Responsible Party):
Guerbet

Brief Summary:
the trial aims to evaluate the Efficacy and Safety of gadopiclenol for Central Nervous System (CNS) Magnetic Resonance Imaging (MRI)

Condition or disease Intervention/treatment Phase
CNS Lesion Blood Brain Barrier Defect Drug: gadopiclenol Drug: Gadobutrol 1Mmol/mL Solution for Injection Vial Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 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 Central Nervous System (CNS) Magnetic Resonance Imaging (MRI)
Actual Study Start Date : June 3, 2019
Estimated Primary Completion Date : August 15, 2020
Estimated Study Completion Date : October 2, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: MRI Scans
Drug Information available for: Gadobutrol

Arm Intervention/treatment
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
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

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
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




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 on the images acquired during the MRI performed with gadopiclenol by independent readers for the 3 most representative lesions.

  2. 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




Information from the National Library of Medicine

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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 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.

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): NCT03996447


Contacts
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Contact: Corinne Dubourdieu +33145915000 corinne.dubourdieu@guerbet.com

Locations
Show Show 38 study locations
Sponsors and Collaborators
Guerbet
Investigators
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Principal Investigator: Lorie Loevner, MD University of Pennsylvania
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Responsible Party: Guerbet
ClinicalTrials.gov Identifier: NCT03996447    
Other Study ID Numbers: GDX-44-010
First Posted: June 24, 2019    Key Record Dates
Last Update Posted: June 4, 2020
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No