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

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

Tracking Information

• First Submitted Date: June 21, 2019
• First Posted Date: June 24, 2019
• Last Update Posted Date: July 2, 2021
• Actual Study Start Date: June 3, 2019
• Actual Primary Completion Date: September 11, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Efficacy and Safety of Gadopiclenol for Central Nervous System (CNS) Magnetic Resonance Imaging (MRI)
• Official Title: 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Diagnostic

Condition

• CNS Lesion
• Blood Brain Barrier Defect

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 30, 2020): 260
• Original Estimated Enrollment (submitted: June 21, 2019): 250
• Actual Study Completion Date: September 11, 2020
• Actual Primary Completion Date: September 11, 2020 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Belgium, France, Germany, Hungary, Italy, Korea, Republic of, Mexico, Poland, Spain, Taiwan, United States

Administrative Information

• NCT Number: NCT03996447
• Other Study ID Numbers: 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: Not Provided
• Current Responsible Party: Guerbet
• Original Responsible Party: Same as current
• Current Study Sponsor: Guerbet
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Lorie Loevner, MD; University of Pennsylvania

• PRS Account: Guerbet
• Verification Date: May 2021