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

• ClinicalTrials.gov Identifier: NCT03986138
• Recruitment Status: Completed
• First Posted: June 14, 2019
• Last Update Posted: November 10, 2021
• Sponsor: Guerbet
• Information provided by (Responsible Party): Guerbet

Tracking Information

• First Submitted Date: June 11, 2019
• First Posted Date: June 14, 2019
• Last Update Posted Date: November 10, 2021
• Actual Study Start Date: August 27, 2019
• Actual Primary Completion Date: December 9, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 12, 2021)

• 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
• 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 (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

• 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 Body Magnetic Resonance Imaging (MRI)
• Official Title: 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: 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: Lesion in Body Region

Intervention

• Drug: gadopiclenol
  Single intravenous bolus injection
• Drug: Gadobutrol 1 MMOLE/ML Intravenous Solution
  Single intravenous bolus injection

Study Arms

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 6, 2021): 304
• Original Estimated Enrollment (submitted: June 11, 2019): 250
• Actual Study Completion Date: December 9, 2020
• Actual Primary Completion Date: December 9, 2020 (Final data collection date for primary outcome measure)

Eligibility 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.

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: Bulgaria, France, Germany, Hungary, Italy, Korea, Republic of, Mexico, Poland, Spain, Ukraine, United States

Administrative Information

• NCT Number: NCT03986138
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Current Responsible Party: Guerbet
• Original Responsible Party: Same as current
• Current Study Sponsor: Guerbet
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Guerbet
• Verification Date: November 2021